A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions (PAPILLON)

June 4, 2026 updated by: Janssen Research & Development, LLC

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. Amivantamab (JNJ-61186372) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody directed against epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) tyrosine kinase receptors that is being developed for the treatment of solid tumors. The hypothesis is that amivantamab, when given in combination with standard of care carboplatin-pemetrexed chemotherapy, will prolong PFS compared with carboplatin-pemetrexed in patients with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins activating mutations. The study will include a Screening phase (28 days), a Treatment phase (from Cycle 1 Day 1 [21-day cycle] till end of treatment [30 days after last dose]) and a Follow up phase (from the end of treatment visit and until the end of study, death, loss to follow-up, or withdrawal of consent from participation in the study, whichever comes first). An independent data monitoring committee (IDMC) will be commissioned for the periodic review of safety and tolerability data, as well as planned efficacy analyses. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis). The total duration of the study is up to 48 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

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

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Chris O'Brien Lifehouse
      • Kogarah, Australia, 2217
        • St George Hospital
      • Malvern, Australia, 3144
        • Cabrini Medical Centre
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Roeselare, Belgium, 8800
        • Algemeen Ziekenhuis Delta
      • Yvoir, Belgium, 5530
        • CHU UCL Namur - Site Godinne
  • Brazil
      • Barretos, Brazil, 14784-400
        • Fundacao Pio XII
      • Belo Horizonte, Brazil, 30110-017
        • Cetus Oncologia
      • Florianópolis, Brazil, 88020-210
        • Ynova Pesquisa Clinica
      • Ijuí, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
      • Natal, Brazil, 59062 000
        • Liga Norte Riograndense contra o cancer
      • Pelotas, Brazil, 96020 080
        • UPCO Unidade de Pesquisa Clinica em Oncologia
      • Porto Alegre, Brazil, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
      • Rio de Janeiro, Brazil, 22 250 905
        • Oncoclinicas Rio de Janeiro S A
      • Rio de Janeiro, Brazil, 22281 100
        • Instituto D Or de Pesquisa e Ensino IDOR
      • Rio de Janeiro, Brazil, 20231 050
        • Ministerio da Saude Instituto Nacional do Cancer
      • Sorocaba, Brazil, 18030-075
        • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa São Camilo
      • São Paulo, Brazil, 01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • São Paulo, Brazil, 01246 000
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • Vitória, Brazil, 29308-014
        • Hospital Evangelico de Cachoeiro de Itapemirim
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, China, 101199
        • Beijing Chest Hospital, Capital Medical University
      • Beijing, China, 102206
        • Peking University International Hospital
      • Beijing, China, 100142
        • Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
      • Changchun, China, 130000
        • Jilin Cancer Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II
      • Changzhou, China, 213003
        • The First People's Hospital of Changzhou
      • Chengdu, China, 610041
        • West China Hospital Sichuan University
      • Chongqing, China, 400030
        • Chongqing University Cancer Hospital
      • Fuzhou, China, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 510080
        • The First Affiliated Hospital Sun Yat sen University
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310009
        • The Second Affiliated Hospital of Zhejiang University College of Medicine
      • Hangzhou, China, 310003
        • The First Affiliated Hospital Zhejiang University College of Medicine
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hangzhou, China, 310009
        • The Second Affiliated Hospital of Zhejiang University College of Medicine 1
      • Harbin, China, 150000
        • Harbin Medical University Cancer Hospital
      • Linhai, China, 317000
        • Taizhou Hospital of Zhejiang Province
      • Nanjing, China, 210031
        • Nanjing Drum Tower Hospital
      • Shanghai, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, China, 200123
        • Shanghai East Hospital
      • Shenyang, China, 110004
        • Shengjing Hospital of China Medical University
      • Shenzhen, China, 518116
        • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
      • Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Weifang, China, 261000
        • Weifang People's Hospital
      • Wuhan, China, 430030
        • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
      • Wuxi, China, 214122
        • Hospital of Jiangnan University
      • Xi'an, China, 710061
        • The First Affiliated Hospital of Xian Jiaotong University
      • Yantai, China, 264000
        • Yantai Yuhuangding Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • France
      • Bordeaux, France, 33000
        • Institut Bergonie
      • Bron, France, 69500
        • Hospices Civils de Lyon HCL
      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Lille, France, 59037
        • CHR Hôpital Calmette
      • Nantes, France, 44093
        • CHU Nantes - Hopital Nord Laënnec
      • Paris, France, 75005
        • Institut Curie
      • Pessac, France, 33604
        • CHU Bordeaux
      • Saint-Mandé, France, 94163
        • HIA Begin
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Cologne, Germany, 50937
        • Universitaetsklinikum Koeln
      • Cologne, Germany, 51109
        • Kliniken der Stadt Koeln gGmbH
      • Gauting, Germany, 82131
        • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
      • Heidelberg, Germany, 69126
        • Thoraxklinik am Universitatsklinikum Heidelberg
      • Heilbronn, Germany, 74072
        • Onkologische Schwerpunktpraxis
      • Moers, Germany, 47441
        • Bethanien Krankenhaus
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Recklinghausen, Germany, 45659
        • Oncologianova GmbH
  • Hungary
      • Budapest, Hungary, H-1529
        • Orszagos Koranyi Tbc es Pulmonologiai Intezet
      • Gyöngyös, Hungary, 3233
        • Mátrai Gyógyintézet-Bronchológia
      • Szombathely, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz
      • Székesfehérvár, Hungary, 8000
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Törökbálint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
  • India
      • Hyderabad, India, 500034
        • Basavatarakam Indo-American Hospital
      • Kolkata, India, 700160
        • Tata Medical Center
      • Mumbai, India, 400012
        • Tata Memorial Hospital
      • Nashik, India, 422002
        • HCG Manavta Cancer Centre
      • New Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research Centre
      • Pune, India, 411013
        • Noble Hospital Pvt Ltd
  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Kfar Saba, Israel, 44281
        • Meir Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bologna, Italy, 40138
        • A O U Sant Orsola Malpighi
      • Catania, Italy, 95123
        • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20132
        • Irccs Ospedale San Raffaele
      • Monza, Italy, 20052
        • San Gerardo Hospital
      • Ravenna, Italy, 48121
        • Ospedale S. Maria Delle Croci
      • Roma, Italy, 00168
        • Irccs Gemelli
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
      • Bunkyō City, Japan, 113 8431
        • Juntendo University Hospital
      • Hidaka, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Himeji, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Hirakata, Japan, 573 1191
        • Kansai Medical University Hospital
      • Kanazawa, Japan, 920 8641
        • Kanazawa University Hospital
      • Kashiwa, Japan, 277 8577
        • National Cancer Center Hospital East
      • Kishiwada, Japan, 596-8501
        • Kishiwada City Hospital
      • Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Kurashiki, Japan, 710-8602
        • Kurashiki Central Hospital
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Matsusaka, Japan, 515-8544
        • Matsusaka Municipal Hospital
      • Nagoya, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • Nagoya, Japan, 464 8681
        • Aichi Cancer Center Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka Sayama Shi, Japan, 589 8511
        • Kindai University Hospital
      • Sagamihara, Japan, 252-0375
        • Kitasato University Hospital
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Shiwa-gun, Japan, 028-3695
        • Iwate Medical University Hospital
      • Shizuoka, Japan, 411 8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 135 8550
        • The Cancer Institute Hospital of JFCR
      • Toon-shi, Japan, 791-0295
        • Ehime University Hospital
      • Wakayama, Japan, 641 8510
        • Wakayama Medical University Hospital
      • Yamaguchi, Japan, 755-0241
        • National Hospital Organization Yamaguchi Ube Medical Center
  • Malaysia
      • George Town, Malaysia, 10990
        • Hospital Pulau Pinang
      • Johor Bahru, Malaysia, 81100
        • Hospital Sultan Ismail
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
  • Mexico
      • Chihuahua City, Mexico, 31217
        • Centro Oncologico de Chihuahua
      • Guadalajara, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Mexico City, Mexico, 14080
        • Instituto Nacional De Cancerologia
      • Mexico City, Mexico, 14050
        • Médica Sur
      • Mexico City, Mexico, 03100
        • Mexico Centre for Clinical Research, S.A. de C.V.
      • Monterrey, Mexico, 64710
        • i Can Oncology Center
      • México, Mexico, 03100
        • Health Pharma Professional Research
      • Naucalpan, Mexico, 53100
        • Oncologia Integral Satelite
  • Poland
      • Bydgoszcz, Poland, 85 796
        • Centrum Onkologii im Prof F Lukaszczyka
      • Gdansk, Poland, 80 214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Poland, 81 519
        • Szpitale Pomorskie Sp z o o
      • Olsztyn, Poland, 10-357
        • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
      • Poznan, Poland, 60-693
        • Private Specialist Hospitals - MedPolonia
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Portugal
      • Lisbon, Portugal, G1R 2J6
        • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
      • Lisbon, Portugal, 1998-018
        • Hosp. Cuf Descobertas
      • Porto, Portugal, 4099-001
        • Centro Hospitalar Universitario do Porto, EPE
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia
      • Vila Nova de Gaia, Portugal, 4434 502
        • Centro Hospitalar de Vila Nova de Gaia Espinho E P E
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Center for Oncology Trials LLC
  • Russia
      • Irkutsk, Russia, 664035
        • Irkutsk Regional Oncology Dispensary
      • Krasnogorsk, Russia, 143423
        • Moscow City Oncology Hospital № 62
      • Krasnoyarsk, Russia, 660133
        • Krasnoyarsk Regional Oncology Dispensary
      • Kuzmolovsky, Russia, 188663
        • Leningrad Regional Oncology Dispensary
      • Moscow, Russia, 115533
        • MCK
      • Nal'chik, Russia, 360000
        • City Clinical Hospital #1
      • Nizhny Novgorod, Russia, 603000
        • Nizhny Novgorod Regional Oncological Dispensary
      • Saint Petersburg, Russia, 197758
        • N.N. Petrov Research Institute Of Oncology
      • Saint Petersburg, Russia, 194291
        • Leningrad Regional Clinical Hospital
      • Saint Petersburg, Russia, 196006
        • Oncology Medical Clinics AV Medical group
      • Tomsk, Russia, 634050
        • Tomsk Cancer Research Institute
      • Ufa, Russia, 450083
        • Bashkir State Medical University
      • Yaroslavl, Russia, 150054
        • Yaroslavl Regional Clinical Oncology Hospital
  • South Korea
      • Busan, South Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Gyeonggi-do, South Korea, 10408
        • National Cancer Center 1
      • Gyeongsangnam-do, South Korea, 52727
        • Gyeongsang National University Hospital
      • Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03181
        • Kangbuk Samsung Hospital
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Mary s Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Hosp Univ A Coruna
      • Badalona, Spain, 08916
        • Inst. Cat. D'Oncologia-Badalona
      • Barcelona, Spain, 08025
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Hosp. Univ. Quiron Dexeus
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Burgos, Spain, 09003
        • Hosp. Univ. de Burgos
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28007
        • Hosp. Gral. Univ. Gregorio Maranon
      • Majadahonda, Spain, 28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Málaga, Spain, 29010
        • Hosp Virgen de La Victoria
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Seville, Spain, 41013
        • Hosp. Virgen Del Rocio
      • Zaragoza, Spain, 50009
        • Hosp. Clinico Univ. Lozano Blesa
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Medical Foundation
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital and Medical College
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital, Prince of Songkla University
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Adana City Hospital
      • Adana, Turkey (Türkiye), 01250
        • Başkent University Medical Faculty Adana Application and Research Center
      • Ankara, Turkey (Türkiye), 6560
        • Gazi University Hospital
      • Ankara, Turkey (Türkiye), 6800
        • Ankara Bilkent City Hospital
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34722
        • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol Mega University Hospital
      • Izmir, Turkey (Türkiye), 35580
        • Izmir Medical Park Hospital
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
      • Kyiv, Ukraine, 02091
        • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
      • Kyiv, Ukraine, 03022
        • National Cancer Institute
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre Western General
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Trust Chelsea
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Trust Sutton
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope 2
      • Orange, California, United States, 92868
        • University of California Irvine
      • Santa Monica, California, United States, 90404
        • UCLA
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer & Research Institute
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Regional Cancer Care Associates LLC
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • Langone Health at NYC University, NYU School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Health
    • Texas
      • Tyler, Texas, United States, 75702
        • Texas Oncology Pa
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Salem, Virginia, United States, 24153
        • Blue Ridge Cancer Care

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
  • A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

  • Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
  • Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
  • Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
  • Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Amivantamab + Chemotherapy
Participants will receive pemetrexed 500 milligram per meter square (mg/m^2) intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin area under the concentration-time curve 5 milligram per milliliter (mg/mL) per minute (AUC 5) will be administered as IV infusion on Day 1 of each 21 day cycle, for up to 4 cycles. Participants will receive amivantamab 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will continue to receive the amivantamab plus chemotherapy in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.
Drug: Amivantamab
Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3 and will continue the same treatment in OLE phase then in LTE phase.
Other Names:
  • JNJ-61186372
Drug: Pemetrexed
Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.
Drug: Carboplatin
Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Drug: Pemetrexed
Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.
Experimental: Arm B: Chemotherapy Alone
Participants will receive pemetrexed 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. Carboplatin AUC 5 IV infusion will be administered on Day 1 of each 21-day cycle for up to 4 cycles. Following the primary analysis for efficacy, the study will transition to an OLE phase and participants will either continue to receive the chemotherapy or cross over to amivantamab in OLE phase. Participants who completed OLE period will enter LTE period and continue to receive same treatment.
Drug: Pemetrexed
Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm A and will continue the same treatment in OLE phase then in LTE phase.
Drug: Carboplatin
Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Drug: Pemetrexed
Pemetrexed will be administered as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arm B and will continue the same treatment in OLE phase then in LTE phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: From randomization to either disease progression or death whichever occurs first (up to 29 months)
PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum).
From randomization to either disease progression or death whichever occurs first (up to 29 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Duration of Response (DoR)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Overall Survival (OS)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Time to Subsequent Therapy (TST)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Progression-Free Survival After First Subsequent Therapy (PFS2)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Time to Symptomatic Progression (TTSP)
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Number of Participants Treatment-emergent Adverse Events (TEAEs)
Time Frame: From Day 1 to 5 years 2 months
From Day 1 to 5 years 2 months
Number of Participants TEAEs With Severity
Time Frame: From Day 1 to 5 years 2 months
From Day 1 to 5 years 2 months
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Number of Participants With Vital Signs Abnormalities
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Number of Participants With Physical Examination Abnormalities
Time Frame: Up to 5 years 3 months
Up to 5 years 3 months
Serum Concentration of Amivantamab
Time Frame: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Number of Participants With Anti-Amivantamab Antibodies
Time Frame: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Time Frame: From baseline to 5 years 3 months
From baseline to 5 years 3 months
Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Time Frame: From baseline to 5 years 3 months
From baseline to 5 years 3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108850
  • 2020-000633-40 (EudraCT Number)
  • 61186372NSC3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-506033-29-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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