AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3PAPILLONNCT04538664

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

A Phase 3 study testing Amivantamab, Pemetrexed and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 232 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Amivantamab, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
232 sitesin 26 countries
Study dates
13 Oct 2020to 31 Dec 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

232 sites in 26 countries.

232 sites in 26 countries

China34 sites

  • Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II

    Beijing, 100142

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese PLA General Hospital

    Beijing, 100853

  • Beijing Chest hospital, Capital medical university

    Beijing, 101199

  • Peking University International Hospital

    Beijing, 102206

  • Jilin cancer hospital

    Changchun, 130000

  • Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II

    Changsha, 410013

  • Hunan Cancer hospital

    Changsha, 410013

  • The First People's Hospital Of Changzhou

    Changzhou, 213003

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University College of Medicine 1

    Hangzhou, 310009

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin medical university cancer hospital

    Harbin, 150000

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000

  • Nanjing Drum Tower Hospital

    Nanjing, 210031

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai East Hospital

    Shanghai, 200123

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, 518116

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Weifang People's Hospital

    Weifang, 261000

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

  • Hospital of Jiangnan University

    Wuxi, 214122

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Japan23 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Kishiwada City Hospital

    Kishiwada, 596-8501

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • Kurashiki Central Hospital

    Kurashiki, 710-8602

  • Kurume University Hospital

    Kurume, 830-0011

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Aichi Cancer Center Hospital

    Nagoya, 464 8681

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Iwate Medical University Hospital

    Shiwa-gun, 028-3695

  • Shizuoka Cancer Center

    Shizuoka, 411 8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Ehime University Hospital

    Toon-shi, 791-0295

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • National Hospital Organization Yamaguchi Ube Medical Center

    Yamaguchi, 755-0241

Other trials in Japan

United States17 sites

  • University Cancer And Blood Center LLC

    Athens, Georgia, 30607

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope 2

    Duarte, California, 91010

  • Regional Cancer Care Associates LLC

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Langone Health at NYC University, NYU School of Medicine

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • University of California Irvine

    Orange, California, 92868

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • UCLA

    Santa Monica, California, 90404

  • Sanford Health

    Sioux Falls, South Dakota, 57104

  • Washington University Medical Center

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer & Research Institute

    Tampa, Florida, 33612

  • Texas Oncology Pa

    Tyler, Texas, 75702

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Brazil16 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Cetus Oncologia

    Belo Horizonte, 30110-017

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20231 050

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

    Sorocaba, 18030-075

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Vitória, 29308-014

Other trials in Brazil

Spain15 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. de Burgos

    Burgos, 09003

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

  • Hosp Virgen de La Victoria

    Málaga, 29010

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Russia13 sites

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035

  • Moscow City Oncology Hospital No 62

    Krasnogorsk, 143423

  • Krasnoyarsk Regional Oncology Dispensary

    Krasnoyarsk, 660133

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663

  • MCK

    Moscow, 115533

  • City Clinical Hospital #1

    Nal'chik, 360000

  • Nizhny Novgorod Regional Oncological Dispensary

    Nizhny Novgorod, 603000

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Oncology Medical Clinics AV Medical group

    Saint Petersburg, 196006

  • N.N. Petrov Research Institute Of Oncology

    Saint Petersburg, 197758

  • Tomsk Cancer Research Institute

    Tomsk, 634050

  • Bashkir State Medical University

    Ufa, 450083

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl, 150054

Other trials in Russia

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • National Cancer Center 1

    Gyeonggi-do, 10408

  • GyeongSang National University Hospital

    Gyeongsangnam-do, 52727

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

Other trials in South Korea

Germany10 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Kliniken der Stadt Koeln gGmbH

    Cologne, 51109

  • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

    Gauting, 82131

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126

  • Onkologische Schwerpunktpraxis

    Heilbronn, 74072

  • Bethanien Krankenhaus

    Moers, 47441

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Oncologianova GmbH

    Recklinghausen, 45659

Other trials in Germany

Italy10 sites

  • A O U Sant Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

    Catania, 95123

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • San Gerardo Hospital

    Monza, 20052

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Irccs Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

France9 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Hospices Civils de Lyon HCL

    Bron, 69500

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • CHR Hôpital Calmette

    Lille, 59037

  • CHU Nantes - Hopital Nord Laënnec

    Nantes, 44093

  • Institut Curie

    Paris, 75005

  • CHU Bordeaux

    Pessac, 33604

  • HIA Begin

    Saint-Mandé, 94163

Other trials in France

Turkey (Türkiye)9 sites

  • Adana City Hospital

    Adana, 01060

  • Başkent University Medical Faculty Adana Application and Research Center

    Adana, 01250

  • Gazi University Hospital

    Ankara, 6560

  • Ankara Bilkent City Hospital

    Ankara, 6800

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

    Istanbul, 34098

  • Medipol Mega University Hospital

    Istanbul, 34214

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Izmir Medical Park Hospital

    Izmir, 35580

Other trials in Turkey (Türkiye)

Mexico8 sites

  • Centro Oncologico de Chihuahua

    Chihuahua City, 31217

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Health Pharma Professional Research

    México, 03100

  • Mexico Centre for Clinical Research, S.A. de C.V.

    Mexico City, 03100

  • Médica Sur

    Mexico City, 14050

  • Instituto Nacional de Cancerologia

    Mexico City, 14080

  • i Can Oncology Center

    Monterrey, 64710

  • Oncologia Integral Satelite

    Naucalpan, 53100

Other trials in Mexico

India6 sites

  • Basavatarakam Indo-American Hospital

    Hyderabad, 500034

  • Tata Medical Center

    Kolkata, 700160

  • Tata Memorial Hospital

    Mumbai, 400012

  • HCG Manavta Cancer Centre

    Nashik, 422002

  • Rajiv Gandhi Cancer Institute & Research Centre

    New Delhi, 110085

  • Noble Hospital Pvt Ltd

    Pune, 411013

Other trials in India

Poland6 sites

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Private Specialist Hospitals - MedPolonia

    Poznan, 60-693

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Medical Foundation

    Kaohsiung City, 833

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Hungary5 sites

  • Orszagos Koranyi Tbc es Pulmonologiai Intezet

    Budapest, H-1529

  • Mátrai Gyógyintézet-Bronchológia

    Gyöngyös, 3233

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, 8000

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Israel5 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Portugal5 sites

  • Hosp. Cuf Descobertas

    Lisbon, 1998-018

  • Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

    Lisbon, G1R 2J6

  • Centro Hospitalar Universitario do Porto, EPE

    Porto, 4099-001

  • Instituto Portugues de Oncologia

    Porto, 4200-072

  • Centro Hospitalar de Vila Nova de Gaia Espinho E P E

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

Australia4 sites

  • Chris O'Brien Lifehouse

    Camperdown, 2050

  • St George Hospital

    Kogarah, 2217

  • Cabrini Medical Centre

    Malvern, 3144

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

Other trials in Australia

Malaysia4 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Belgium3 sites

  • UZ Leuven

    Leuven, 3000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

  • CHU UCL Namur - Site Godinne

    Yvoir, 5530

Other trials in Belgium

Canada3 sites

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Thailand3 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Songklanagarind Hospital, Prince of Songkla University

    Songkhla, 90110

Other trials in Thailand

Ukraine3 sites

  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

    Dnipro, 49102

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091

  • National Cancer Institute

    Kyiv, 03022

Other trials in Ukraine

United Kingdom3 sites

  • Edinburgh Cancer Centre Western General

    Edinburgh, EH4 2XU

  • The Royal Marsden NHS Trust Chelsea

    London, SW3 6JJ

  • The Royal Marsden NHS Trust Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

Puerto Rico1 site

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: 61186372NSC3001: 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.

Being tested
Amivantamab, Pemetrexed, Carboplatin
Keywords
EGFR Exon20ins Mutation, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmivantamabDrug

    Also called JNJ-61186372

    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.

  • PemetrexedDrug

    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.

  • CarboplatinDrug

    Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.

  • PemetrexedDrug

    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.

Study groups in NCT04538664
Study groupRoleWhat they receive
Arm A: Amivantamab + ChemotherapyExperimentalParticipants 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.
Receives: Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin
Arm B: Chemotherapy AloneExperimentalParticipants 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.
Receives: Drug: Carboplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From randomization to either disease progression or death whichever occurs first (up to 29 months)

Secondary outcomes (15)

  1. Objective Response Rate (ORR)

    Measured: Up to 5 years 3 months

  2. Duration of Response (DoR)

    Measured: Up to 5 years 3 months

  3. Overall Survival (OS)

    Measured: Up to 5 years 3 months

  4. Time to Subsequent Therapy (TST)

    Measured: Up to 5 years 3 months

  5. Progression-Free Survival After First Subsequent Therapy (PFS2)

    Measured: Up to 5 years 3 months

  6. Time to Symptomatic Progression (TTSP)

    Measured: Up to 5 years 3 months

  7. Number of Participants Treatment-emergent Adverse Events (TEAEs)

    Measured: From Day 1 to 5 years 2 months

  8. Number of Participants TEAEs With Severity

    Measured: From Day 1 to 5 years 2 months

  9. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Up to 5 years 3 months

  10. Number of Participants With Vital Signs Abnormalities

    Measured: Up to 5 years 3 months

  11. Number of Participants With Physical Examination Abnormalities

    Measured: Up to 5 years 3 months

  12. Serum Concentration of Amivantamab

    Measured: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)

  13. Number of Participants With Anti-Amivantamab Antibodies

    Measured: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)

  14. Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    Measured: From baseline to 5 years 3 months

  15. Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)

    Measured: From baseline to 5 years 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2020
  2. Study start13 Oct 2020
  3. Primary completion3 May 2023
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04538664
Sponsor's protocol ID
CR108850
Other IDs
61186372NSC3001, 2023-506033-29-00, 2023
Acronym
PAPILLON
Status last verified
Nov 2026
First submitted
31 Aug 2020
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Publications

  • Tang K, Wu F, Yang F, Yao Y, Zhao Y, Zhou J, Sun P, Wang D, Lv D, Wang H, Hu Y, Li Q, Song Y, Gao G, Pan F, Bhattacharya A, Baig M, Lorenzini PA, Wortman-Vayn H, Agrawal T, Zhou C. Amivantamab plus chemotherapy vs. chemotherapy as first-line treatment in Chinese mainland patients with EGFR exon 20 insertion non-small cell lung cancer: Subgroup analysis of the randomized PAPILLON trial. Chin Med J (Engl). 2026 May 26. doi: 10.1097/CM9.0000000000004134. Online ahead of print.

    PubMed 42192224

  • 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.

    PubMed 41671628

  • 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.

    PubMed 41184595

  • 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.

    PubMed 40922529

  • 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.

    PubMed 37870976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amivantamab, Pemetrexed and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 232 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in China, Japan, United States, Brazil, Spain and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04538664, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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