Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Datopotamab Deruxtecan; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

Detailed Description

The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations, as well as participants who are TROP2 NMR+ at baseline. TROP2 NMR will be retrospectively assessed.

Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.

• Study Type: Interventional
• Enrollment (Estimated): 1170
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina
    • Centro de Investigaciones Medicas y Desarrollo LC SRL
  • Ciudad Autonoma de Buenos Aire, Argentina, 1125
    • Fundacion CENIT para la investigación en Neurociencias
  • Mar del Plata, Argentina, 7600
    • Hospital de La Comunidad
  • Pergamino, Argentina, B2700
    • Centro de Investigacion Pergamino SA
  • Rosario, Argentina, S2000DSV
    • Sanatorio Parque
  • Rosario, Argentina, 2000DSK
    • Instituto de Oncología de Rosario
  • Rosario, Argentina
    • Sanatorio Británico
  • San Juan, Argentina, 5400
    • Centro Polivalente de Asistencia E Investigacion Clinica Cer San Juan
  • Viedma, Argentina, 8500
    • Centro de Investigaciones Clinicas. Clinica Viedma S.A.
• Australia
  • Adelaide, Australia, 5000
    • CRSA/ St Andrews Hospital
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre (Fmc)
  • Frankston, Australia, 3199
    • PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)
  • Kogarah, Australia, 2217
    • St George Public Hospital
  • Wollongong, Australia, 2500
    • Southern Medical Day Care Centre
  • Woolloongabba, Australia, QLD 4102
    • Princess Alexandra Hospital
• Austria
  • Feldkirch, Austria, 6800
    • Landeskrankenhaus Feldkirch
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt Pulmologie
  • Vienna, Austria, 1210
    • Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf
• Belgium
  • Ghent, Belgium, 9000
    • Az Maria Middelares - Campus Maria Middelares
  • Haine-Saint-Paul, Belgium
    • Centre Hospitalier Jolimont-Lobbes
  • Hasselt, Belgium, 3500
    • Jessa Hospital
  • Ottignies, Belgium
    • Cliniques Saint Pierre Ottignies (CSPO)
  • Sint-Niklaas, Belgium, 9100
    • AZ Nikolaas
• Brazil
  • Belo Horizonte, Brazil, 30130 090
    • Personal Oncologia de Precisao - Cenantron
  • Caxias do Sul, Brazil, 95070-560
    • Fundaco Universidade de Caxias Do Sul- Instituto de Pesquisas Em Saude Ips-Ucs
  • Curitiba, Brazil, 81520-060
    • Hospital Erasto Gaertner
  • Ijuí, Brazil, 98700-000
    • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
  • ItajaĂ-, Brazil, 88301-220
    • Clinica de Neoplasias Litoral Ltda
  • Pelotas, Brazil, 96020-080
    • Clnica Lacks
  • Porto Alegre, Brazil, 90050-170
    • Santa Casa de Misericordia de Porto Alegre
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer - INCA
  • Santo André, Brazil, 09060-870
    • Centro de Estudos e Pesquisa de Hematologia e Oncologia - CEPHO
  • São Paulo, Brazil, 01236-030
    • Instituto de Ensino e Pesquisa São Lucas
  • Taubaté, Brazil, 12030-200
    • Instituto do Cancer Brasil - Unidade Taubate
• Canada
  • Québec, Canada, G1J 1Z4
    • CHU de Quebec -Universite Laval Hopital de L'Enfant-Jesus
• Chile
  • Santiago, Chile
    • Fundación Arturo López Pérez
  • Santiago, Chile, 7500000
    • Oncovida
  • Santiago, Chile, 7500653
    • Centro de Estudios Clínicos SAGA SpA
  • Santiago, Chile, 7500713
    • Orlandi Oncología
  • Viña del Mar, Chile
    • Oncocentro Apys
  • ViĂąa Del Mar, Chile, 254-0488
    • Centro de Investigaciones Clinicas Vina Del Mar
• China
  • Beijing, China, 100044
    • Peking University Peoples Hospital
  • Beijing Sheng, China, 100142
    • Peking University Cancer Hospital Beijing Cancer Hospital Beijing Institute for Cancer Research
  • Cangzhou, China, 061000
    • Cangzhou Peoples Hospital
  • Changchun, China, 130000
    • Jilin Cancer Hospital
  • Changchun, China, 130000
    • First Affiliated Hospital of Medical College of Jilin University
  • Changsha, China, 410011
    • Hunan Cancer Hospital
  • Chengdu, China, 610041
    • University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute SIC
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
  • Fuzhou, China, 350001
    • Fujian Medical University - Union Hospital Foochow Christian Union Hospital
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Guangzhou, China, 510080
    • The First Affiliated Hospital Sun Yat-Sen University
  • Guangzhou, China, 510095
    • Affiliated Cancer Hospital and Insititute of Guangzhou Medical University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine Zhejiang University
  • Hangzhou, China, 310000
    • Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Harbin, China, 150081
    • Harbin Medical University Cancer Hospital
  • Hefei, China
    • An Hui Cancer Hospital
  • Hohhot, China, 010050
    • Inner Mongolia Medical University- the Affiliated Hospital
  • Jiamusi, China, 154007
    • Jiamusi Cancer Hospital
  • Linyi, China, 276000
    • Linyi Cancer Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanjing, China, 210009
    • Zhongda Hospital, Southeast University
  • Shanghai, China, 200030
    • Shanghai Chest Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110042
    • Liaoning cancer Hospital & Institute
  • Wuhan, China, 430022
    • Union Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Xi'an, China, 710061
    • The First Affiliate Hospital of Xi'An Jiaotong University
  • Xianyang, China, 441021
    • Xiangyang Central Hospital
  • Zhengzhou, China, 450003
    • Henan Cancer Hospital
  • Ürümqi, China, 830000
    • The First Affiliated Hosptial of Xinjiang Medical University
• Czechia
  • Brno, Czechia, 63500
    • FN Brno Klinika Nemoci Plicnich a TBC
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc FNOL
• France
  • Avignon, France
    • Sainte-Catherine Institut du Cancer Avignon-Provence
  • Besançon, France, 25000
    • Hopital Jean Minjoz - CHU de Besancon
  • Bordeaux, France, 33075
    • CHU de Bordeaux - Hôpital Saint André
  • France, France, 86021
    • Centre Hospitalier Universitaire, CHU, de Poitiers
  • Lyon, France, 69008
    • Centre Leon Berard
  • Lyon, France, 69003
    • Hôpital Lyon Sud
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Marseille, France, 13015
    • APHM - Hôpital Nord
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nantes, France, 44000
    • CHU de Nantes
  • Nantes, France, 44277
    • Hopital prive du Confluent
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75020
    • Tenon Hospital
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Suresnes, France, 92150
    • Hopital Foch
• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Chemnitz, Germany, 9116
    • Klinikum Chemnitz
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen GmbH
  • Freiburg im Breisgau, Germany, 79106
    • Universitaetsklinikum Freiburg
  • Giessen, Germany
    • University Hospital Giessen, ZIM IV
  • Mannheim, Germany
    • External pharmacy Fortuna Herstellung GmbH of main site Universitaetsmedizin Mannheim
  • Munich, Germany, 80336
    • Ludwig-Maximilians University Hospital of Munich
  • Münster, Germany, 48149
    • University Hospital Mănster
• Greece
  • Athens, Greece, 11527
    • Sotiria General Hospital of Chest Diseases
  • Athens, Greece
    • Metropolitan Hospital - Athens
  • Heraklion, Greece, 71110
    • University General Hospital of Heraklion
  • Ioannina, Greece, 45500
    • University Hospital of Ioannina Uhi
  • Neo Faliro, Greece, 18547
    • Metropolitan Hospital
  • Pátrai, Greece, 26443
    • Olympion Hospital
  • Thessaloniki, Greece, 546 45
    • Euromedica General Clinic of Thessaloniki
  • Thessaloniki, Greece
    • St. Luke's Hospital
  • Thessalonki, Greece, 54622
    • Bioclinic Thessaloniki (Galinos clinic)
• Hong Kong
  • Hong Kong, Hong Kong, 99999
    • Prince of Wales Hospital / The Chinese University of Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Tuen Mun Hospital
  • Pok Fu Lam, Hong Kong, 999077
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1121
    • National Koranyi Institute For Pulmonology
  • Farkasgyepű, Hungary, 8582
    • Veszprem Megyei Tudogyogyintezet Farkasgyepu
  • KecskemĂŠt, Hungary, 6000
    • Bkmk Hospital
  • Szolnok, Hungary, 5007
    • Hetenyi G Korhaz, Onkologiai Kozpont
  • Székesfehérvár, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Korhaz Pulmonologiai Osztaly
  • Törökbálint, Hungary
    • Reformatus Pulmonologiai Centrum
• Italy
  • Candiolo, Italy, 10060
    • Istituto Di Candiolo Irccs
  • Lucca, Italy
    • Ospedale San Luca
  • Orbassano, Italy, 10043
    • Azienda Ospedaliero - Universitaria San Luigi Gonzaga
  • Rome, Italy
    • Ifo Regina Elena
  • Udine, Italy, 33100
    • Ospedale S. Maria Della Misericordia
  • Varese, Italy, 21100
    • ASST Sette Laghi
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Roma Crc - Centro Ricerche Clinich
• Japan
  • Ehime, Japan
    • NHO Shikoku Cancer Center
  • Fukoka, Japan, 830-0011
    • Kurume University Hospital
  • Fukuoka, Japan, 812-0054
    • Kyushu University Hospital
  • Fukuoka, Japan, 811-1395
    • Kyushu Cancer Center
  • Hokkaido, Japan, 006-0811
    • Teine Keijinkai Hospital
  • Hyōgo, Japan, 663-8501
    • Hyogo Medical University Hospital
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kanagawa, Japan, 252-0375
    • Kitasato University Hospital
  • Kumamoto, Japan, 861-4193
    • Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectual University of Medicine
  • Mie, Japan, 515-8544
    • Matsusaka Municipal Hospital
  • Miyagi, Japan, 981-0914
    • Sendai Kousei Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 573-1191
    • Kansai Medical University Hospital
  • Osaka, Japan, 540-0008
    • Osaka International Cancer Institute
  • Osaka, Japan, 591-8555
    • NHO Kinki-Chuo Chest Medical Center
  • Osaka, Japan, 560-8552
    • Osaka Toneyama Medical Center
  • Tochigi, Japan, 321-0293
    • Dokkyo Medical University Hospital
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 143-8540
    • Toho University Omori Medical Center
  • Tokyo, Japan, 113-0021
    • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  • Tokyo, Japan, 135-0063
    • The Cancer Institute Hospital of JFCR
  • Yamaguchi, Japan, 740-8510
    • Iwakuni Clinical Center
  • Yamaguchi, Japan, 755-0241
    • Yamaguchi-Ube Medical Center
  • Yamanashi, Japan, 400-8506
    • Yamanashi Prefectural Central Hospital
• Mexico
  • Cuauhtémoc, Mexico
    • Cryptex Investigacion Clinica Sa de Cv
  • Guadalajara, Mexico
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Mexico City, Mexico
    • Instituto Nacional De Cancerologia
  • Mexico City, Mexico
    • Health Pharma Professional Research S.A de C.V.
  • Oaxaca City, Mexico
    • Centro de Investigacion Clinica de Oaxaca CICLO
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5200 ME
    • Jeroen Bosch Ziekenhuis Jbz
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • Leiden, Netherlands, 2333ZA
    • Leiden University Medical Center
• Poland
  • Bialystok, Poland, 15-540
    • II Klinika Chorob Pluc I Gruzlicy
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej
  • Lodz, Poland, 93-338
    • Instytut Centrum Zdrowia Matki Polki (Iczmp)
  • Lublin, Poland, 20-954
    • SPSK4, Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Poznan, Poland, 60-693
    • Med Polonia Sp. z o.o.
  • Warsaw, Poland, 02-778
    • Maria Sklodowska-Curie National Research Institute of Oncology
• Portugal
  • Lisbon, Portugal, 1400-038
    • Fundação Champalimaud
  • Porto, Portugal
    • Hospital CUF Porto
  • Porto, Portugal, 4150-001
    • IPO Porto Francisco Gentil, E.P.E.
• Romania
  • Cluj-Napoca, Romania, 400015
    • Institute of Oncology Prof. Dr. Ion Chiricuta
  • Craiova, Romania, 200094
    • Onco Clinic Consult SA
  • Craiova, Romania, 200745
    • Centrul de Oncologie Sfantu Nectarie
  • Jud Timis, Romania
    • SC Oncomed SRL
  • Timișoara, Romania, 300166
    • Oncocenter Oncologie Clinica S.R.L
• South Korea
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Gangnam-Gu, South Korea, 6351
    • Samsung Medical Center
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Jinju-si Gyeongsangnam-do, South Korea, 52727
    • Gyeongsang National University Hospital
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 3722
    • Yonsei University Health System - Severance Hospital
  • Seoul, South Korea, 6591
    • The Catholic Univ. of Korea, Seoul St. Marys Hospital
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08035
    • Vall Hebron University Hospital
  • Lleida, Spain, 25198
    • Hospital Universitario Arnau de Vilanova
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Málaga, Spain, 29011
    • Hospital Regional Universitario Malaga
  • Ourense, Spain, 32005
    • CHUO
  • Seville, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Seville, Spain, 41009
    • Hosp Univ Virgen Macarena
  • Valenica, Spain, 46026
    • Hospital Universitario y Politecnico de la Fe
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Switzerland
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen
  • Thun, Switzerland, 3600
    • Spital STS AG
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital
  • Hsia, Taiwan
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 112
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10055
    • National Taiwan University Hospital
  • Taoyuan District, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi hospital
  • Bangkok, Thailand, 10330
    • Faculty of Medicine Chulalongkorn University
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
  • Hat Yai, Thailand, 90110
    • Prince of Songkla University PSU - Faculty of Medicine
  • Nonthaburi, Thailand, 40002
    • Khon Kaen University - Faculty of Medicine-Srinagarind Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1230
    • Baskent University
  • Ankara, Turkey (Türkiye), 6800
    • Ankara Bilkent City Hospital
  • Antalya, Turkey (Türkiye), 7070
    • Akdeniz University Hospital
  • Bağcılar, Turkey (Türkiye), 34214
    • Medipol Mega University Hospital
  • Bornova-Izmir, Turkey (Türkiye)
    • Ege Universitesi Gogus Hastaliklari Poliklinigi
  • Cankaya/Ankara, Turkey (Türkiye), 6520
    • Memorial Ankara Hospital
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul Medeniyet University Medical Faculty
  • Seyhan, Turkey (Türkiye)
    • Adana Acibadem Hospital
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center Pc
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer and Research Centers
    • Prescott Valley, Arizona, United States, 86314
      • Arizona Oncology Associates, PC - NAHOA
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Prebyterian
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care Medical Group
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic
    • Santa Monica, California, United States, 90404
      • Ronald Reagan UCLA Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • UCHealth Memorial Hospital
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists - South
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialist of North Florida
    • Palm Bay, Florida, United States, 32901
      • Cancer Care Centers of Brevard, Inc.
    • Pensacola, Florida, United States, 32503
      • Woodlands Medical Specialists, PA
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists-North
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Emory University - Winship Cancer Institute Wci
  • Illinois
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners of Maryland
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Heamtology P.A.
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute; Inv Drg Svc Pharm
    • Brighton, Massachusetts, United States, 02135
      • Dana Farber Cancer Institute At St. Elizabeth'S Medical Center
    • Foxborough, Massachusetts, United States, 02035
      • Dana Farber Brigham Cancer Center
    • Milford, Massachusetts, United States, 01757
      • Dana Farber At Milford Regional Cancer Center
    • South Weymouth, Massachusetts, United States, 02190
      • Dana Farber/Bwcc in Affiliation With South Shore Hospital
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Astera Cancer Care
    • Hackensack, New Jersey, United States, 07601
      • Regional Cancer Care Associates LLC
  • New York
    • New Hyde Park, New York, United States, 11042
      • North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park
    • Patchogue, New York, United States, 11772
      • North Shore Hematology Oncology Associates
    • Port Jefferson Station, New York, United States, 11776
      • North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
    • The Bronx, New York, United States, 10469
      • North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx
  • Texas
    • McAllen, Texas, United States, 78503
      • Texas Oncology, P.A.
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
    • Sugar Land, Texas, United States, 77479
      • Texas Oncology, P.A.
    • Tyler, Texas, United States, 75702
      • Texas Oncology-Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists IHO Corp
  • Washington
    • Lacey, Washington, United States, 98503
      • Providence Regional Cancer System
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is >18 years old).
3. Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of 6 slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study.
4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study.
5. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease and should not have progressed on or within the 6 months of completion.
6. Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.

Key Exclusion Criteria:

1. Has received prior systemic treatment for advanced/metastatic NSCLC.

2. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):

   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
   2. TROP2-targeted therapy
   3. Any anti-PD-1, anti-PD-L1, or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
   4. Any other ICIs Subjects who received adjuvant or neoadjuvant therapy other than those listed above are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced or metastatic disease.

3. Has received a live vaccine within 30 days prior to the first dose of study treatment.

   Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. For any subject receiving an approved severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine, please follow the vaccine label and/or local guidance. The vaccine manufacturer and the date of administration should be recorded on the electronic case report form (Concomitant Medications page), as should any AEs relating to the vaccine (including hypersensitivity or allergies). Note: Any licensed SARS-CoV2 vaccine (including those authorized for emergency use) in a particular country is allowed in the study as long as the vaccine is an mRNA vaccine, replication-incompetent adenoviral vaccine, or inactivated vaccine. Such vaccines will be treated just as any other concomitant therapy.

   Investigational vaccines (ie, those not licensed or authorized for emergency use) are not allowed.

4. Has spinal cord compression or clinically active untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI with contrast preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator must delay of study treatment to document stability of CNS metastases with repeat imaging at least 2 weeks later (in which case, repeat of all screening activity may be required).

5. Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including:

   1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the 12-lead electrocardiogram [ECG] performed at screening).
   2. Myocardial infarction within 6 months prior to Cycle 1 Day 1.
   3. History of a serious cardiac arrhythmia requiring treatment
   4. Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
   5. Left ventricular ejection fraction (LVEF) <50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization.
   6. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
   7. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).
6. Clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dato-DXd + Pembrolizumab + Platinum Chemotherapy; Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).	Drug: Datopotamab Deruxtecan; Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: Dato-DXd; Drug: Pembrolizumab; Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA®; Drug: Carboplatin; Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.; Drug: Cisplatin; Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Experimental: Dato-DXd + Pembrolizumab; Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.	Drug: Datopotamab Deruxtecan; Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: Dato-DXd; Drug: Pembrolizumab; Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA®
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Chemotherapy; Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).	Drug: Pembrolizumab; Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA®; Drug: Carboplatin; Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.; Drug: Cisplatin; Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.; Drug: Pemetrexed; Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.; Other Names: Alimta; Pemfexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants	Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival Based on Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive	Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Overall Survival in All Randomized Participants	Overall Survival (OS) is defined as the time from randomization to death due to any cause.	From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Overall Survival in All Randomized Participants who are TROP2 NMR positive	Overall Survival (OS) is defined as the time from randomization to death due to any cause.	From randomization until disease progression or death (whichever occurs first), up to approximately 76 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants	Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Objective Response Rate by Blinded Independent Central Review in All Randomized Participants who are TROP2 NMR positive	Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Objective Response Rate by Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Duration of Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1.	From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
Time to Response by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1.	From randomization to date of first objective response (CR or PR), up to approximately 43 months
Disease Control Rate by BICR and Investigator in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1.	From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Progression-free Survival 2 in Both All Randomized Participants and Randomized Participants who are TROP2 NMR positive	Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice	From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Time to Deterioration	Time to Deterioration (TTD) is defined as the time from randomization to first onset of a ≥10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent ≥10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a ≥10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13).	From randomization until disease progression or death (whichever occurs first), up to approximately 76 months
Number of Participants With Treatment-emergent Adverse Events (TEAE)	A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment.	Up to 76 months
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA	The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.	Baseline and up to 76 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo
• Collaborators: Merck Sharp & Dohme LLC; AstraZeneca
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

General Publications

• Okamoto I, Kuyama S, Girard N, Lu S, Franke F, Li Z, Danchaivijitr P, Han JY, Sun JM, Sugawara S, Pan E, Ren N, Chen A, Rajagopalan R, Lisberg AE. TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab +/- platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer. Future Oncol. 2024;20(37):2927-2936. doi: 10.1080/14796694.2024.2409621. Epub 2024 Oct 29.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): May 11, 2029
• Study Completion (Estimated): May 11, 2029

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pembrolizumab; Pemetrexed; Datopotamab Deruxtecan (Dato-DXd); Metastatic Non Small Cell Lung Cancer; Advanced Non Small Cell Lung Cancer; Tropion-Lung07
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Platinum Compounds; Pemetrexed; Carboplatin; Cisplatin; pembrolizumab
• Other Study ID Numbers: DS1062-A-U303; 2022-500802-16-00 (Other Identifier: EU CT Number); TROPION-Lung07 (Other Identifier: DAIICHI SANKYO); MK-3475-E10 (Other Identifier: Merck); jRCT2061220066 (Registry Identifier: jRCT Number); KEYNOTE-E10 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No