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)

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: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Pemetrexed

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: Interventional
• Enrollment (Actual): 308
• Phase: Phase 3

Expanded Access

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Contacts and Locations

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 Clinica 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 Francois 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to 5 years 3 months
Duration of Response (DoR)	Up to 5 years 3 months
Overall Survival (OS)	Up to 5 years 3 months
Time to Subsequent Therapy (TST)	Up to 5 years 3 months
Progression-Free Survival After First Subsequent Therapy (PFS2)	Up to 5 years 3 months
Time to Symptomatic Progression (TTSP)	Up to 5 years 3 months
Number of Participants Treatment-emergent Adverse Events (TEAEs)	From Day 1 to 5 years 2 months
Number of Participants TEAEs With Severity	From Day 1 to 5 years 2 months
Number of Participants With Clinical Laboratory Abnormalities	Up to 5 years 3 months
Number of Participants With Vital Signs Abnormalities	Up to 5 years 3 months
Number of Participants With Physical Examination Abnormalities	Up to 5 years 3 months
Serum Concentration of Amivantamab	Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
Number of Participants With Anti-Amivantamab Antibodies	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)	From baseline to 5 years 3 months
Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)	From baseline to 5 years 3 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Zhou C, Tang KJ, Cho BC, Liu B, Paz-Ares L, Cheng S, Kitazono S, Thiagarajan M, Goldman JW, Sabari JK, Sanborn RE, Mansfield AS, Hung JY, Boyer M, Popat S, Mourao Dias J, Felip E, Majem M, Gumus M, Kim SW, Ono A, Xie J, Bhattacharya A, Agrawal T, Shreeve SM, Knoblauch RE, Park K, Girard N; PAPILLON Investigators. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. N Engl J Med. 2023 Nov 30;389(22):2039-2051. doi: 10.1056/NEJMoa2306441. Epub 2023 Oct 21.
• Sanborn RE, Zhou C, Tang KJ, Cho BC, Cheng S, Popat S, Ono A, Lu S, Majem M, Aguilar A, Del Rosario Garcia Campelo M, Hayashi H, Lee KY, Lee SH, Delmonte A, Alatorre-Alexander J, Richardson G, Santos V, Dooms C, Sabari JK, Shu CA, Girard N, Mansfield AS, Park K, Xia Y, Bhattacharya A, Buyukkaramikli N, Perualila N, Diels J, Acharya S, Chandler C, Proskorovsky I, Dearden L, Wortman-Vayn H, Mahadevia PJ, Knoblauch RE, Agrawal T, Baig M, Felip E. Amivantamab-Chemotherapy in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertions: Impact of Treatment Crossover and Other Endpoints from the Phase III PAPILLON Study. Target Oncol. 2025 Nov;20(6):979-989. doi: 10.1007/s11523-025-01182-0. Epub 2025 Nov 3.
• Kitazono S, Ono A, Kawamura T, Hataji O, Tanaka H, Matsumoto S, Watanabe N, Nagashima H, Oki M, Takahashi M, Anazawa T, Shirai T, Yamashita A, Wortman-Vayn H, Bhattacharya A, Agrawal T, Baig M, Knoblauch RE, Hayashi H. Amivantamab Plus Chemotherapy in Japanese Patients With EGFR Exon 20 Insertions NSCLC. Cancer Sci. 2025 Nov;116(11):3139-3148. doi: 10.1111/cas.70180. Epub 2025 Sep 8.
• Zhou C, Tang KJ, Liu B, Kim SW, Kitazono S, Ono A, Thiagarajan M, Hung JY, Boyer M, CIl T, Yao Y, Nagarkar R, Xie J, Bhattacharya A, Wortman-Vayn H, Baig M, Agrawal T, Lorenzini P, Lee SH, Cho BC. Amivantamab plus chemotherapy versus chemotherapy for first-line treatment of participants with EGFR exon 20 insertion-mutated advanced non-small cell lung cancer: PAPILLON Asia subgroup analysis. Lung Cancer. 2026 Mar;213:109302. doi: 10.1016/j.lungcan.2026.109302. Epub 2026 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): May 3, 2023
• Study Completion (Estimated): August 2, 2027

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; EGFR Exon20ins Mutation
• 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; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Pemetrexed; Carboplatin; amivantamab
• Other Study ID 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