Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

June 3, 2026 updated by: Pfizer

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.

To join the study, participants must meet the following conditions:

Be 18 years or older.
Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.
Is not a candidate for complete surgical resection or curative chemoradiotherapy.
Do not have known actionable genomic alterations
Be treatment naïve for advanced or metastatic disease

Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.

Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:

Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.
Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.

Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.

The study will include regular visits for:

Treatment and health checks: while participant continues receiving treatment.
Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1410

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1056ABI
    - Recruiting
    - Centro de Investigaciones Metabólicas (CINME)
  - La Rioja, Argentina, F5300COE
    - Not yet recruiting
    - Fundación CORI para la Investigación y Prevención del Cáncer
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1122AAL
    - Recruiting
    - Instituto Argentino de Diagnóstico y Tratamiento (IADT)
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - Recruiting
    - Investigaciones Oncologicas C. Colon S.A.
  - Pilar, Buenos Aires, Argentina, 1629
    - Not yet recruiting
    - Hospital Universitario Austral
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, C1425
    - Recruiting
    - Investigaciones Clinicas Moleculares (ICM)
  - CABA, Buenos Aires F.D., Argentina, C1430EGF
    - Recruiting
    - Clinica Adventista Belgrano
- Córdoba Province
  - Córdoba, Córdoba Province, Argentina, X5004BAL
    - Recruiting
    - Hospital Italiano de Córdoba
Australia
- New South Wales
  - Kingswood, New South Wales, Australia, 2747
    - Not yet recruiting
    - Nepean Hospital
- Queensland
  - Birtinya, Queensland, Australia, 4575
    - Recruiting
    - Sunshine Coast University Hospital
  - Gympie, Queensland, Australia, 4570
    - Recruiting
    - Gympie Hospital
  - Nambour, Queensland, Australia, 4560
    - Recruiting
    - Nambour General Hospital
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Mater Misericordiae Limited
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Recruiting
    - Icon Cancer Centre Hobart
- Victoria
  - Melbourne, Victoria, Australia, 3065
    - Recruiting
    - St Vincent's Hospital
Brazil
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
    - Recruiting
    - Hospital Moinhos de Vento
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14051-140
    - Recruiting
    - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
  - Santo André, São Paulo, Brazil, 09060-650
    - Recruiting
    - Faculdade de Medicina do ABC
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 5G2
    - Recruiting
    - Arthur J.E. Child Comprehensive Cancer Centre
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Not yet recruiting
    - Princess Margaret Cancer Centre - University Health Network
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Recruiting
    - Centre Integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint -Jean
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - McGill University Health Centre
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Recruiting
    - Centre integre universitaire de sante et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
China
- - Nanjing, China, 210031
    - Not yet recruiting
    - Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  - Shanghai, China, 200123
    - Not yet recruiting
    - Shanghai East Hospital
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Not yet recruiting
    - Beijing Cancer Hospital
  - Beijing, Beijing Municipality, China, 100730
    - Not yet recruiting
    - Beijing Peking Union Medical College Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510515
    - Recruiting
    - Southern Medical University Nanfang Hospital
  - Huizhou, Guangdong, China, 516001
    - Recruiting
    - Huizhou Central People's Hospital
- Guangxi
  - Nanning, Guangxi, China, 530200
    - Not yet recruiting
    - Guangxi Medical University Affiliated Tumor Hospital
- Henan
  - Luoyang, Henan, China, 471003
    - Recruiting
    - The First Affiliated Hospital of Henan University of Science &Technology
  - Luoyang, Henan, China, 471000
    - Recruiting
    - The First Affiliated Hospital of Henan University of Science &Technology
- Hubei
  - Wuhan, Hubei, China, 430048
    - Not yet recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
  - Xiangyang, Hubei, China, 441106
    - Not yet recruiting
    - Xiangyang Central Hospital
- Hunan
  - Changsha, Hunan, China, 410011
    - Not yet recruiting
    - The Second Xiangya Hospital of Central South University
  - Changsha, Hunan, China, 410008
    - Not yet recruiting
    - Xiangya Hospital Central South University
- Jiangsu
  - Yangzhou, Jiangsu, China, 225001
    - Recruiting
    - Northern Jiangsu People's Hospital
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Not yet recruiting
    - The First Affiliated Hospital of Nanchang University
- Shandong
  - Jinan, Shandong, China, 250013
    - Recruiting
    - Jinan Central Hospital
  - Linyi, Shandong, China, 276001
    - Not yet recruiting
    - LinYi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Not yet recruiting
    - Fudan University Shanghai Cancer Center
- Shanxi
  - Taiyuan, Shanxi, China, 030000
    - Not yet recruiting
    - Shanxi Cancer Hospital
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Not yet recruiting
    - Sichuan Cancer Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310003
    - Not yet recruiting
    - The first Affiliated Hospital, Zhejiang University School of Medicine
  - Taizhou, Zhejiang, China, 317000
    - Not yet recruiting
    - Taizhou Hospital of Zhejiang Province
  - Wenzhou, Zhejiang, China, 325000
    - Not yet recruiting
    - The First Affiliated Hospital of Wenzhou Medical University
Czechia
- - Olomouc, Czechia, 779 00
    - Not yet recruiting
    - Fakultni nemocnice Olomouc
  - Ostrava, Czechia, 703 84
    - Recruiting
    - Nemocnice AGEL Ostrava - Vitkovice a.s.
  - Pardubice, Czechia, 532 03
    - Not yet recruiting
    - Multiscan s.r.o.
  - Prague, Czechia, 140 59
    - Not yet recruiting
    - Fakultni Thomayerova nemocnice
France
- - Paris, France, 75014
    - Recruiting
    - Groupe Hospitalier Paris Saint Joseph
  - Paris, France, 75014
    - Not yet recruiting
    - Hopitaux Universitaires Paris Centre-Hopital Cochin
  - Villejuif, France, 94805
    - Not yet recruiting
    - Gustave Roussy
- Haute Vienne
  - Limoges, Haute Vienne, France, 87042
    - Recruiting
    - Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
- Maine ET Loire
  - Angers, Maine ET Loire, France, 49055
    - Not yet recruiting
    - Institut de Cancérologie de l'Ouest
- Île-de-France Region
  - Boulogne-Billancourt, Île-de-France Region, France, 92100
    - Not yet recruiting
    - Hôpital Ambroise Paré
Germany
- - Berlin, Germany, 14165
    - Not yet recruiting
    - Helios Klinikum Emil von Behring Berlin-Zehlendorf
  - Chemnitz, Germany, 09116
    - Not yet recruiting
    - Klinikum Chemnitz gGmbH
  - Düsseldorf, Germany, 40479
    - Not yet recruiting
    - Marien Hospital Düsseldorf
  - Gera, Germany, 07548
    - Recruiting
    - SRH Wald-Klinikum Gera GmbH
  - Großhansdorf, Germany, 22927
    - Not yet recruiting
    - LungenClinic Grosshansdorf
- Hesse
  - Kassel, Hesse, Germany, 34125
    - Not yet recruiting
    - Klinikum Kassel GmbH
- Lower Saxony
  - Georgsmarienhütte, Lower Saxony, Germany, 49124
    - Not yet recruiting
    - Franziskus-Hospital Harderberg
Greece
- Attikí
  - Athens, Attikí, Greece, 155 62
    - Not yet recruiting
    - Metropolitan General Hospital
- Kentrikí Makedonía
  - Thessaloniki, Kentrikí Makedonía, Greece, 570 01
    - Not yet recruiting
    - European Interbalkan Medical Center
Hungary
- - Tatabánya, Hungary, 2800
    - Recruiting
    - Komarom-Esztergom Varmegyei Szent Borbala Korhaz
- Somogy County
  - Kaposvár, Somogy County, Hungary, 7400
    - Not yet recruiting
    - Somogy Vármegyei Kaposi Mór Oktató Kórház
India
- Gujarat
  - Surat, Gujarat, India, 395002
    - Recruiting
    - Nirmal Hospital Pvt Ltd.
  - Vadodara, Gujarat, India, 391760
    - Recruiting
    - Kailash Cancer Hospital & Research Centre
- Haryana
  - Gurugram, Haryana, India, 122001
    - Not yet recruiting
    - Artemis hospital
- Karnataka
  - Bangalore, Karnataka, India, 560085
    - Recruiting
    - Radhakrishna Multispecialty Hospital & IVF Centre
  - Belagavi, Karnataka, India, 590010
    - Recruiting
    - KLES Dr. Prabhakar Kore Hospital & M.R.C
  - Bengaluru, Karnataka, India, 560069
    - Not yet recruiting
    - Spandana Oncology Center
- Maharashtra
  - Nagpur, Maharashtra, India, 441108
    - Recruiting
    - National Cancer Institute
  - Nashik, Maharashtra, India, 422009
    - Recruiting
    - Apex Wellness Hospital
  - Pune, Maharashtra, India, 411004
    - Recruiting
    - Sahyadri Super Speciality Hospital
  - Thane, Maharashtra, India, 401107
    - Recruiting
    - Bhakti Vedanta Hospital and Research Institute
- Odisha
  - Bhubaneswar, Odisha, India, 751007
    - Recruiting
    - Sparsh Hospitals
- Telangana
  - Hyderabad, Telangana, India, 500034
    - Recruiting
    - Basavatarakam Indo American Cancer Hospital & Research Institute
Israel
- HA Merkaz
  - Ramat Gan, HA Merkaz, Israel, 5265601
    - Not yet recruiting
    - Sheba Medical Center
  - Ẕerifin, HA Merkaz, Israel, 7033001
    - Not yet recruiting
    - Yitzhak Shamir Medical Center
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 9112001
    - Recruiting
    - Hadassah Medical Center
  - Jerusalem, Jerusalem, Israel, 9103102
    - Recruiting
    - Shaare Zedek Medical Center
- TELL ABĪB
  - Tel Aviv, TELL ABĪB, Israel, 6423906
    - Recruiting
    - Sourasky Medical Center
Italy
- - Ravenna, Italy, 48121
    - Recruiting
    - Ausl Della Romagna- Ospedale Santa Maria Delle Croci Ravenna
- Campania
  - Naples, Campania, Italy, 80131
    - Not yet recruiting
    - Istituto Nazionale Tumori IRCCS Fondazione Pascale
- FC
  - Meldola, FC, Italy, 47014
    - Not yet recruiting
    - IRCCS Istituto Romagnolo per lo Studio Tumori (IRST) "Dino Amadori"
- Lombardy
  - Milan, Lombardy, Italy, 20141
    - Not yet recruiting
    - Istituto Europeo di Oncologia IRCCS
- ROME
  - Roma, ROME, Italy, 00144
    - Not yet recruiting
    - IRCCS Istituto Nazionale dei Tumori Regina Elena
  - Roma, ROME, Italy, 00186
    - Not yet recruiting
    - Ospedale Isola Tiberina - Gemelli Isola
Japan
- - Fukuoka, Japan, 810-8563
    - Recruiting
    - National Hospital Organization Kyushu Medical Center
  - Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center
  - Kochi, Japan, 780-8077
    - Recruiting
    - National Hospital Organization Kochi National Hospital
  - Kyoto, Japan, 612-8555
    - Recruiting
    - National Hospital Organization Kyoto Medical Center
  - Okayama, Japan, 701-1192
    - Recruiting
    - National Hospital Organization Okayama Medical Center
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 466-8560
    - Recruiting
    - Nagoya University Hospital
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - Recruiting
    - National Hospital Organization Shikoku Cancer Center
- Fukuoka
  - Kurume, Fukuoka, Japan, 830-0011
    - Recruiting
    - Kurume University Hospital
- Gunma
  - Otashi, Gunma, Japan, 373-8550
    - Recruiting
    - Gunma Prefectural Cancer Center
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0047
    - Recruiting
    - Kobe City Medical Center General Hospital
  - Kobe, Hyōgo, Japan, 650-0046
    - Recruiting
    - Kobe Minimally invasive Cancer Center
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - Recruiting
    - NHO Mito Medical Center
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8650
    - Recruiting
    - National Hospital Organization Kanazawa Medical Center
- Kochi
  - Nankoku, Kochi, Japan, 783-8505
    - Not yet recruiting
    - Kochi Medical School Hospital
- Mie-ken
  - Tsu, Mie-ken, Japan, 514-1101
    - Recruiting
    - Mie Chuo Medical Center
- Miyagi
  - Sendai, Miyagi, Japan, 9810914
    - Recruiting
    - Sendai Kousei Hospital
- Nagasaki
  - Ōmura, Nagasaki, Japan, 856-8562
    - Recruiting
    - National Hospital Organization Nagasaki Medical Center
- Niigata
  - Niigata, Niigata, Japan, 951-8566
    - Recruiting
    - Niigata Prefectural Cancer Center Niigata Hospital
- Oita Prefecture
  - Beppu, Oita Prefecture, Japan, 874-0011
    - Recruiting
    - National Hospital Organization Beppu Medical Center
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital
  - Suita, Osaka, Japan, 565-0871
    - Recruiting
    - The University of Osaka Hospital
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8603
    - Recruiting
    - Nippon Medical School Hospital
  - Chuo-ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital
  - Kiyose, Tokyo, Japan, 204-8585
    - Recruiting
    - National Hospital Organization Tokyo National Hospital
  - Shinjyuku-ku, Tokyo, Japan, 162-8655
    - Recruiting
    - National Center for Global Health and Medicine
- Yamaguchi
  - Ube, Yamaguchi, Japan, 755-0241
    - Not yet recruiting
    - National Hospital Organization Yamaguchi Ube Medical Center
Poland
- - Lodz, Poland, 90-302
    - Not yet recruiting
    - Instytut MSF Sp zoo
  - Opole, Poland, 45-061
    - Not yet recruiting
    - SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
  - Wroclaw, Poland, 53-413
    - Not yet recruiting
    - Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-519
    - Not yet recruiting
    - Pratia Onkologia Katowice
Puerto Rico
- - Dorado, Puerto Rico, 00646
    - Recruiting
    - Pan American Center for Oncology Trials, LLC- Dorado Office
  - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Pan American Center for Oncology Trials, LLC
  - San Juan, Puerto Rico, 00917
    - Recruiting
    - BRCR Global Puerto Rico - Hato Rey
Spain
- - Barcelona, Spain, 08041
    - Not yet recruiting
    - Hospital De La Santa Creu I Sant Pau
  - Granada, Spain, 18016
    - Recruiting
    - Hospital Universitario San Cecilio
  - Huelva, Spain, 21005
    - Recruiting
    - Hospital Universitario Juan Ramon Jimenez
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Universitario Fundacion Jimenez Díaz
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Clinico San Carlos
  - Palma, Spain, 07120
    - Not yet recruiting
    - Hospital Universitari Son Espases
  - Seville, Spain, 41014
    - Not yet recruiting
    - Hospital Universitario Virgen de Valme
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet
- A Coruña [LA Coruña]
  - Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
    - Recruiting
    - CHUS - Hospital Clinico Universitario
- Alicante
  - Elche, Alicante, Spain, 03203
    - Not yet recruiting
    - Hospital General Universitario de Elche
- Barcelona [barcelona]
  - Barcelona, Barcelona [barcelona], Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Barcelona [barcelona], Spain, 08003
    - Recruiting
    - Parc de Salut Mar - Hospital del Mar
- Cádiz
  - Jerez de la Frontera, Cádiz, Spain, 11407
    - Not yet recruiting
    - Hospital Jerez de la Frontera
- Girona [gerona]
  - Girona, Girona [gerona], Spain, 17007
    - Not yet recruiting
    - Institut Català d'Oncologia (ICO) - Girona
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de octubre
  - Madrid, Madrid, Comunidad de, Spain, 28009
    - Recruiting
    - Hospital General Universitario Gregorio Marañon
  - Torrejón de Ardoz, Madrid, Comunidad de, Spain, 28850
    - Recruiting
    - Hospital Universitario de Torrejón
Taiwan
- - Hsinchu, Taiwan, 300195
    - Recruiting
    - National Taiwan University Hospital - Hsinchu branch
  - Kaohsiung City, Taiwan, 83301
    - Recruiting
    - Chang Gung Memorial Hospital at Kaohsiung
  - Taichung, Taiwan, 40447
    - Not yet recruiting
    - China Medical University Hospital
  - Taichung, Taiwan, 402306
    - Recruiting
    - Chung Shan Medical University Hospital
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Not yet recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 110
    - Recruiting
    - Taipei Medical University Hospital
  - Taipei, Taiwan, 106
    - Recruiting
    - National Taiwan University Cancer Center (NTUCC)
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Medical Foundation-Linkou Branch
- Changhua
  - Changhua County, Changhua, Taiwan, 50006
    - Recruiting
    - Changhua Christian Hospital
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01140
    - Not yet recruiting
    - Adana Medical Park Seyhan Hastanesi
  - Ankara, Turkey (Türkiye), 06560
    - Recruiting
    - Gazi University Health Research and Application Center Gazi Hospital
  - Ankara, Turkey (Türkiye), 06520
    - Not yet recruiting
    - Memorial Ankara Hastanesi
  - Ankara, Turkey (Türkiye), 06010
    - Not yet recruiting
    - Gulhane Egitim Arastirma Hastanesi
  - Diyarbakır, Turkey (Türkiye), 21200
    - Recruiting
    - Dicle Üniversitesi
  - Samsun, Turkey (Türkiye), 55200
    - Not yet recruiting
    - Samsun Medical Park Hastanesi
- İstanbul
  - Istanbul, İstanbul, Turkey (Türkiye), 34010
    - Not yet recruiting
    - Istinye University - Liv Hospital - Topkapi
  - Istanbul, İstanbul, Turkey (Türkiye), 34722
    - Not yet recruiting
    - TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  - Istanbul, İstanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Medipol Mega Universite Hastanesi
United States
- Arizona
  - Bullhead City, Arizona, United States, 86442
    - Recruiting
    - Pioneer Research Center
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Gilbert, Arizona, United States, 85297
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Glendale, Arizona, United States, 85306
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Goodyear, Arizona, United States, 85395
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Mesa, Arizona, United States, 85202
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Mesa, Arizona, United States, 85206
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Phoenix, Arizona, United States, 85028
    - Recruiting
    - Ironwood Cancer & Research Centers
  - Scottsdale, Arizona, United States, 85260
    - Recruiting
    - Ironwood Cancer & Research Centers
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Recruiting
    - Highlands Oncology Group
  - Rogers, Arkansas, United States, 72758
    - Recruiting
    - Highlands Oncology Group
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Highlands Oncology Group
- California
  - Anaheim, California, United States, 92805
    - Recruiting
    - Los Angeles Cancer Network - Anaheim
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Orange Coast Memorial Medical Center
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Los Angeles Cancer Network - Fountain Valley
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Memorial Care Orange Coast Medical Center Attn
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - OC Blood and Cancer Care
  - Laguna Hills, California, United States, 92653
    - Recruiting
    - Memorial Care Saddleback Medical Center Attn
  - Lodi, California, United States, 95242
    - Not yet recruiting
    - Stockton Hematology Oncology Medical Group
  - Long Beach, California, United States, 90806
    - Recruiting
    - Memorial Care Long Beach Medical Center
  - Los Angeles, California, United States, 90017
    - Recruiting
    - Los Angeles Cancer Network - Good Samaritan
  - Manteca, California, United States, 95336
    - Not yet recruiting
    - Stockton Hematology Oncology Medical Group
  - Modesto, California, United States, 95350
    - Not yet recruiting
    - Stockton Hematology Oncology Medical Group
  - Riverside, California, United States, 92501
    - Recruiting
    - Los Angeles Cancer Network - Riverside
  - Santa Barbara, California, United States, 93105
    - Recruiting
    - Sansum Clinic
  - Solvang, California, United States, 93463
    - Recruiting
    - Sansum Clinic
  - Stockton, California, United States, 95204
    - Not yet recruiting
    - Stockton Hematology Oncology Group
  - Tracy, California, United States, 95377
    - Not yet recruiting
    - Stockton Hematology Oncology Medical Group
  - Van Nuys, California, United States, 91405
    - Recruiting
    - Los Angeles Cancer Network - Valley Presbyterian
- Florida
  - Bonita Springs, Florida, United States, 34135
    - Recruiting
    - Florida Cancer Specialists
  - Bradenton, Florida, United States, 34211
    - Recruiting
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33909
    - Recruiting
    - Florida Cancer Specialists
  - Clearwater, Florida, United States, 33761
    - Recruiting
    - Florida Cancer Specialists
  - Coral Springs, Florida, United States, 33065
    - Recruiting
    - BRCR Global- Coral Springs
  - Daytona Beach, Florida, United States, 32117
    - Recruiting
    - Florida Cancer Specialists
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Florida Cancer Specialists
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Cancer Specialists of North Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Recruiting
    - Helios Clinical Research
  - Fort Myers, Florida, United States, 33908
    - Recruiting
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33901
    - Recruiting
    - Florida Cancer Specialists - South
  - Fort Myers, Florida, United States, 33905
    - Recruiting
    - Florida Cancer Specialists
  - Gainesville, Florida, United States, 32605
    - Recruiting
    - Florida Cancer Specialists
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32204
    - Recruiting
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32218
    - Recruiting
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32258
    - Recruiting
    - Cancer Specialists of North Florida
  - Largo, Florida, United States, 33770
    - Recruiting
    - Florida Cancer Specialists
  - Lecanto, Florida, United States, 34461
    - Recruiting
    - Florida Cancer Specialists
  - N. Venice, Florida, United States, 34275
    - Recruiting
    - Florida Cancer Specialists
  - Naples, Florida, United States, 34102
    - Recruiting
    - Florida Cancer Specialists
  - Neptune Beach, Florida, United States, 32266
    - Recruiting
    - Cancer Specialists of North Florida
  - Ocala, Florida, United States, 34474
    - Recruiting
    - Florida Cancer Specialists
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Mid Florida Hematology and Oncology Center
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Florida Cancer Specialists
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Cancer Institute
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Florida Cancer Specialists
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Ambulatory Care Center
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Orlando Health Orlando Regional Medical Center
  - Palm Bay, Florida, United States, 32901
    - Recruiting
    - Cancer Care Centers of Brevard, Inc.
  - Palm Beach Gardens, Florida, United States, 33410
    - Recruiting
    - Florida Cancer Specialists
  - Port Charlotte, Florida, United States, 33980
    - Recruiting
    - Florida Cancer Specialists
  - Port Saint Lucie, Florida, United States, 34952
    - Recruiting
    - Hematology Oncology Associates of the Treasure Coast
  - Saint Augustine, Florida, United States, 32086
    - Recruiting
    - Cancer Specialists of North Florida
  - Sarasota, Florida, United States, 34236
    - Recruiting
    - Florida Cancer Specialists
  - Sebring, Florida, United States, 33870
    - Recruiting
    - Florida Cancer Specialists
  - St. Petersburg, Florida, United States, 33705
    - Recruiting
    - Florida Cancer Specialists
  - St. Petersburg, Florida, United States, 33701
    - Recruiting
    - Florida Cancer Specialists
  - Tallahassee, Florida, United States, 32308
    - Recruiting
    - Florida Cancer Specialists
  - Tamarac, Florida, United States, 33321
    - Recruiting
    - BRCR Medical Center Inc.
  - Tampa, Florida, United States, 33607
    - Recruiting
    - Florida Cancer Specialists
  - Tavares, Florida, United States, 32778
    - Recruiting
    - Florida Cancer Specialists
  - The Villages, Florida, United States, 32159
    - Recruiting
    - Florida Cancer Specialists
  - Trinity, Florida, United States, 34655
    - Recruiting
    - Florida Cancer Specialists
  - Wellington, Florida, United States, 33414
    - Recruiting
    - Florida Cancer Specialists
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Florida Cancer Specialists - East
  - Winter Park, Florida, United States, 32789
    - Recruiting
    - Florida Cancer Specialists
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Recruiting
    - Illinois Cancer Specialists
  - Bloomington, Illinois, United States, 61704
    - Recruiting
    - Illinois CancerCare - Bloomington
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - University of Illinois Hospital and Health Sciences System
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)
  - Galesburg, Illinois, United States, 61401
    - Recruiting
    - Illinois CancerCare - Galesburg
  - Hinsdale, Illinois, United States, 60521
    - Recruiting
    - Hope and Healing Cancer Services
  - New Lenox, Illinois, United States, 60451
    - Recruiting
    - Hope and Healing Cancer Services
  - Ottawa, Illinois, United States, 61350
    - Recruiting
    - Illinois CancerCare-Ottawa-Fox River Cancer Center
  - Pekin, Illinois, United States, 61554
    - Recruiting
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61615
    - Recruiting
    - Illinois CancerCare, P.C.
  - Peru, Illinois, United States, 61354
    - Recruiting
    - Illinois CancerCare-Peru - Valley Regional Cancer Center
  - Washington, Illinois, United States, 61571
    - Recruiting
    - Illinois CancerCare-Washington
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Not yet recruiting
    - Pontchartrain Cancer Center
  - Hammond, Louisiana, United States, 70403
    - Not yet recruiting
    - Pontchartrain Cancer Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Brandywine, Maryland, United States, 20613
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Columbia, Maryland, United States, 21044
    - Recruiting
    - Maryland Oncology Hematology - Columbia
  - Germantown, Maryland, United States, 20876
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Largo, Maryland, United States, 20774
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Rockville, Maryland, United States, 20850
    - Recruiting
    - Maryland Oncology Hematology, P.A.
  - Silver Spring, Maryland, United States, 20904
    - Recruiting
    - Maryland Oncology Hematology, P.A.
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Chaska, Minnesota, United States, 55318
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Coon Rapids, Minnesota, United States, 55433
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Edina, Minnesota, United States, 55435
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Maple Grove, Minnesota, United States, 55369
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
  - Woodbury, Minnesota, United States, 55125
    - Recruiting
    - Minnesota Oncology Hematology, P.A.
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Cancer Partners of Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - NHO Revive Research Institute, LLC
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - NHO Support Center
- New York
  - Albany, New York, United States, 12206
    - Recruiting
    - New York Oncology Hematology
  - Clifton Park, New York, United States, 12065
    - Recruiting
    - New York Oncology Hematology
  - Nyack, New York, United States, 10960
    - Recruiting
    - Hematology Oncology Associates of Rockland
- North Carolina
  - Wilson, North Carolina, United States, 27893
    - Recruiting
    - Carolina Cancer Research Center
- Ohio
  - Cincinnati, Ohio, United States, 45245
    - Recruiting
    - Oncology Hematology Care Clinical Trials
  - Cincinnati, Ohio, United States, 45211
    - Recruiting
    - Oncology Hematology Care Clinical Trials
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - Oncology Hematology Care Clinical Trials
  - Fairfield, Ohio, United States, 45014
    - Recruiting
    - Oncology Hematology Care Clinical Trials
- Oregon
  - Happy Valley, Oregon, United States, 97015
    - Recruiting
    - Northwest Cancer Specialists, P.C
  - Portland, Oregon, United States, 97227
    - Recruiting
    - Northwest Cancer Specialists, P.C.
  - Tigard, Oregon, United States, 97223
    - Recruiting
    - Northwest Cancer Specialists, P.C
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Recruiting
    - Tennessee Oncology, PLLC - Chattanooga Downtown
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Tennessee Oncology, PLLC - Chattanooga - Medical Park II
  - Franklin, Tennessee, United States, 37067
    - Recruiting
    - Tennessee Oncology, PLLC - Franklin
  - Gallatin, Tennessee, United States, 37066
    - Recruiting
    - Tennessee Oncology, PLLC - Gallatin
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Tennessee Cancer Specialists Dowell Springs location
  - Knoxville, Tennessee, United States, 37932
    - Recruiting
    - Tennessee Cancer Specialists - Parkwest Location
  - Lebanon, Tennessee, United States, 37090
    - Recruiting
    - Tennessee Oncology, PLLC - Lebanon
  - Mount Juliet, Tennessee, United States, 37122
    - Recruiting
    - Tennesseee Oncology, PLLC - Mount Juliet
  - Murfreesboro, Tennessee, United States, 37129
    - Recruiting
    - Tennessee Oncology, PLLC - Murfreesboro
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - SCRI Oncology Partners
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
  - Nashville, Tennessee, United States, 37205
    - Recruiting
    - Tennessee Oncology, PLLC - Saint Thomas West
  - Shelbyville, Tennessee, United States, 37160
    - Recruiting
    - Tennessee Oncology, PLLC -Shelbyville
- Texas
  - Abilene, Texas, United States, 79606
    - Recruiting
    - Texas Oncology - West Texas
  - Allen, Texas, United States, 75013
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Amarillo, Texas, United States, 79124
    - Recruiting
    - Texas Oncology - West Texas
  - Arlington, Texas, United States, 76012
    - Not yet recruiting
    - Texas Oncology - DFW
  - Arlington, Texas, United States, 76014
    - Not yet recruiting
    - Texas Oncology - DFW
  - Austin, Texas, United States, 78758
    - Recruiting
    - Texas Oncology - Central/South Texas
  - Beaumont, Texas, United States, 77702
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Bedford, Texas, United States, 76022
    - Not yet recruiting
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75203
    - Not yet recruiting
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75230
    - Not yet recruiting
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75231
    - Not yet recruiting
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75237
    - Not yet recruiting
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75246
    - Not yet recruiting
    - Texas Oncology - DFW
  - Denison, Texas, United States, 75020
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Denton, Texas, United States, 76201
    - Recruiting
    - Texas Oncology - Northeast Texas
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Texas Oncology - West Texas
  - El Paso, Texas, United States, 79915
    - Recruiting
    - Texas Oncology - West Texas
  - El Paso, Texas, United States, 79938
    - Recruiting
    - Texas Oncology - West Texas
  - Flower Mound, Texas, United States, 75028
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Fort Worth, Texas, United States, 76104
    - Not yet recruiting
    - Texas Oncology - DFW
  - Grapevine, Texas, United States, 76051
    - Not yet recruiting
    - Texas Oncology - DFW
  - Harlingen, Texas, United States, 78550
    - Recruiting
    - Texas Oncology - Central/South Texas
  - Houston, Texas, United States, 77024
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77054
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77070
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Humble, Texas, United States, 77338
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Products Center (IPC)
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Products Center
  - Lewisville, Texas, United States, 75056
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Longview, Texas, United States, 75601
    - Recruiting
    - Texas Oncology - Northeast Texas
  - McAllen, Texas, United States, 78503
    - Recruiting
    - Texas Oncology - Central/South Texas
  - McKinney, Texas, United States, 75071
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Midland, Texas, United States, 79701
    - Recruiting
    - Texas Oncology - West Texas
  - Odessa, Texas, United States, 79761
    - Recruiting
    - Texas Oncology - West Texas
  - Palestine, Texas, United States, 75801
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Paris, Texas, United States, 75460
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Pearland, Texas, United States, 77584
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Plano, Texas, United States, 75075
    - Not yet recruiting
    - Texas Oncology - DFW
  - Plano, Texas, United States, 75093
    - Not yet recruiting
    - Texas Oncology - DFW
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - Texas Oncology - Gulf Coast
  - The Woodlands, Texas, United States, 77380
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Texas Oncology - Northeast Texas
  - Waco, Texas, United States, 76712
    - Recruiting
    - Texas Oncology - Central/South Texas
  - Webster, Texas, United States, 77598
    - Recruiting
    - Texas Oncology - Gulf Coast
  - Weslaco, Texas, United States, 78596
    - Recruiting
    - Texas Oncology - Central/South Texas
  - Wichita Falls, Texas, United States, 76310
    - Recruiting
    - Texas Oncology - West Texas
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Not yet recruiting
    - University of Virginia
  - Charlottesville, Virginia, United States, 22911
    - Not yet recruiting
    - UVA Health Cancer Care Pantops
  - Charlottesville, Virginia, United States, 22903
    - Not yet recruiting
    - UVA Comprehensive Cancer Center
  - Charlottesville, Virginia, United States, 22903
    - Not yet recruiting
    - UVA Health Fontaine Research Park
- Washington
  - Vancouver, Washington, United States, 98684
    - Recruiting
    - Northwest Cancer Specialists, P.C.
- Wisconsin
  - Hudson, Wisconsin, United States, 54016
    - Recruiting
    - Minnesota Oncology Hematology, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

18 years of age or older at screening.
Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).
Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
PD-L1 status available based on local testing results
Measurable disease based on RECIST v1.1 per investigator.
Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
Expected survival ≥12 weeks

Exclusion Criteria:

Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter < 1 cm are permitted.
Participants with clinically significant risk of hemorrhage or fistula are excluded.
Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
History of allogeneic organ / hematopoietic stem cell transplantation.
Participants with any of the following respiratory conditions:
Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
Grade ≥3 pulmonary disease unrelated to underlying malignancy
History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
History of severe bleeding tendency or coagulation dysfunction
History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
Participants with history of immunodeficiency
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Previous systemic anti-tumor therapy including:
1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
2. Previous treatment with immunotherapy
3. Prior radiotherapy > 30 Gy to the lung < 6 months of first dose of study intervention
4. Palliative local therapy < 2 weeks before the first dose of study intervention;
5. Non-specific immunomodulatory therapy < 2 weeks before the first dose.
6. Prior systemic anti-angiogenic therapy
Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
Prior and concomitant therapy:
1. therapeutic oral or parenteral anticoagulants or thrombolytic agents < 10 days to the first dose.
2. chronic antiplatelet therapy <7 days to randomization.
3. live or attenuated live vaccine < 4 weeks to the first dose.
4. current high-dose systemic corticosteroids.
5. prohibited concomitant medication(s) < 21 days to the first dose.
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.	Biological: PF-08634404 Solution for infusion Drug: Chemotherapy Regimen 1 Injection for IV use
Active Comparator: Arm B Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.	Drug: Chemotherapy Regimen 1 Injection for IV use Biological: Pembrolizumab Injection for IV use
Experimental: Arm C Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.	Biological: PF-08634404 Solution for infusion Drug: Chemotherapy Regimen 2 Injection for IV use
Active Comparator: Arm D Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.	Biological: Pembrolizumab Injection for IV use Drug: Chemotherapy Regimen 2 Injection for IV use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: Approximately 39 months	Overall survival defined as the time from the date of randomization to the date of death due to any cause.	Approximately 39 months
Progression Free Survival (PFS) assessed by blinded independent central review (BICR) Time Frame: Approximately 32 months	Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first.	Approximately 32 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by BICR Time Frame: Approximately 32 months	ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR.	Approximately 32 months
Progression Free Survival as assessed by Investigator Time Frame: Approximately 32 months	Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.	Approximately 32 months
Confirmed ORR using RECIST v1.1 as assessed by investigator Time Frame: Approximately 32 months	ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by BICR.	Approximately 32 months
Duration of Response (DoR) as assessed by BICR Time Frame: Approximately 32 months	The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.	Approximately 32 months
Duration of Response (DoR) as assessed by Investigator Time Frame: Approximately 32 months	The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first.	Approximately 32 months
Number of Participants With Adverse Events (AEs) Time Frame: Through end of study and up to approximately 39 months	AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).	Through end of study and up to approximately 39 months
Number of Participants With Clinical Laboratory Abnormalities Time Frame: through end of study and up to approximately 39 months	Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing.	through end of study and up to approximately 39 months
Pharmacokinetics (PK): Serum concentrations of PF-08634404 Time Frame: Through end of study and up to approximately 39 months	Predose and postdose concentrations of PF-08634404	Through end of study and up to approximately 39 months
Incidence of Anti-Drug Antibody (ADA) against PF-08634404. Time Frame: Through end of study and up to approximately 39 months		Through end of study and up to approximately 39 months
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 QLQ-LC13 Time Frame: Approximately 39 months	EORTC QLQ-LC13 is a lung cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire, the EORTC QLQ-C30.	Approximately 39 months
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 Time Frame: Approximately 39 months	TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.	Approximately 39 months
Time to definitive deterioration (TTdD) in in the global health status/QoL and physical function scores on the EORTC QLQ-C30 Time Frame: Approximately 39 months	TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.	Approximately 39 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) and physical function scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Time Frame: Approximately 39 months	The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.	Approximately 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

February 27, 2029

Study Completion (Estimated)

August 26, 2032

Study Registration Dates

First Submitted

October 28, 2025

First Submitted That Met QC Criteria

October 28, 2025

First Posted (Actual)

October 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C6461001
Symbiotic-Lung-01 (Other Identifier: Pfizer)
2025-523461-17-01 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Sidney Kimmel Cancer Center at Thomas Jefferson...
Bristol-Myers Squibb

Terminated

Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer

Stage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...

United States
National Cancer Institute (NCI)

Active, not recruiting

Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)

Lung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7

United States, Puerto Rico
National Cancer Institute (NCI)

Completed

A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC

Stage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma

United States
M.D. Anderson Cancer Center

Completed

Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...

United States
National Cancer Institute (NCI)

Terminated

Pioglitazone Hydrochloride in Treating Patients With Stage IA-IIIA Non-small Cell Lung Cancer

Stage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma

United States
Pfizer

Recruiting

A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)

Non-small Cell Carcinoma | Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Cancer Metastatic

United States, United Kingdom, Canada, Taiwan, China, Belgium, Spain, Australia, France, Czechia, India, Slovakia, Japan, Finland, Greece, Denmark, Puerto Rico, Germany, Netherlands, Bulgaria, Italy, Sweden, Mexico, South Korea, Israel, A... and more
National Cancer Institute (NCI)

Terminated

Azacitidine and Entinostat in Treating Patients With Newly Diagnosed Stage IA-IIIA Non-Small Lung Cancer Undergoing Surgery

Stage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma

United States
University of Southern California
National Cancer Institute (NCI); Society of Thoracic Radiology

Completed

Dynamic Perfusion Computed Tomography in Patients With Localized Non-small Cell Lung Cancer

Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma

United States
Pfizer

Not yet recruiting

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

Carcinoma | Lung Neoplasms | Non-Small Cell Lung Cancer | Lung Disease | Non-Small-Cell Lung | Carcinoma, Non-Small-Cell Lung (NSCLC) | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamous | Lung Cancer (NSCLC)
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Completed

Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following Surgery

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...

United States

Clinical Trials on PF-08634404

Pfizer

Recruiting

Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer

Lung Neoplasms | Small Cell Lung Cancer | Carcinoma, Small Cell Lung | Small Cell Lung Cancer ( SCLC ) | Transformed Small Cell Lung Cancer | Small Cell Cancer Of The Lung

United States, Taiwan, Israel, China, Japan
Pfizer

Recruiting

Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Small Cell Lung Cancer (SCLC)

Spain, Taiwan, Australia, France, Japan, United States, China, Puerto Rico, Italy
Pfizer
Astellas Pharma Inc

Recruiting

Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer

Urothelial Carcinoma | Urothelial Cancer | Advanced/Metastatic Urothelial Cancer

United States, Japan, Australia, Puerto Rico, China
Pfizer

Recruiting

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Non-Small Cell Lung Cancer | Carcinoma, Non-Small Cell Lung | Advanced/Metastatic Non-Small Cell Lung Cancer

United States, Taiwan, Japan, China, Spain, Puerto Rico, Italy
Pfizer
GOG Foundation

Not yet recruiting

Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer

Endometrial Neoplasms | Endometrial Cancer

United States
Pfizer

Not yet recruiting

Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC

Carcinoma | Lung Neoplasms | Non-Small Cell Lung Cancer | Lung Disease | Non-Small-Cell Lung | Carcinoma, Non-Small-Cell Lung (NSCLC) | Non-small Cell Lung Cancer, Squamous | Non-small Cell Lung Cancer, Non-squamous | Lung Cancer (NSCLC)
Pfizer

Recruiting

Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.

Carcinoma, Hepatocellular | Liver Neoplasms | Hepatocellular Carcinoma | Advanced Hepatocellular Carcinoma | Unresectable Hepatocellular Carcinoma | Hepatocellular Cancer | Metastatic Hepatocellular Carcinoma

United States, Taiwan, Japan, Puerto Rico
Pfizer

Recruiting

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Esophageal Adenocarcinoma | Gastroesophageal Junction Cancer | Metastatic Gastric Cancer | Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma

United States, Puerto Rico
Pfizer

Recruiting

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

Digestive System Diseases | Gastrointestinal Diseases | Neoplasms by Site | Gastrointestinal Neoplasms | Digestive System Neoplasms | Colonic Diseases | Intestinal Diseases | Colorectal Neoplasms | Intestinal Neoplasms | Rectal Diseases

United States, Taiwan, China, Canada, Australia, Spain, Japan, France, Belgium, Puerto Rico, Argentina, Poland, Germany, Brazil, Israel, Italy, Denmark
Pfizer

Completed

To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

Healthy

United Kingdom

Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

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product manufactured in and exported from the U.S.

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