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
4 other identifiers
interventional
308
26 countries
232
Brief 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 Exon 20ins mutations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2020
Longer than P75 for phase_3
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 4, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2023
CompletedResults Posted
Study results publicly available
May 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2027
ExpectedJune 8, 2026
June 1, 2026
2.6 years
August 31, 2020
May 1, 2024
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
From randomization to either disease progression or death whichever occurs first (up to 29 months)
Secondary Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
Arm A: Amivantamab + Chemotherapy
EXPERIMENTALParticipants 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.
Arm B: Chemotherapy Alone
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Carboplatin will be administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (232)
City of Hope 2
Duarte, California, 91010, United States
University of California Irvine
Orange, California, 92868, United States
UCLA
Santa Monica, California, 90404, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612, United States
University Cancer And Blood Center LLC
Athens, Georgia, 30607, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816, United States
Langone Health at NYC University, NYU School of Medicine
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Sanford Health
Sioux Falls, South Dakota, 57104, United States
Texas Oncology Pa
Tyler, Texas, 75702, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Chris O'Brien Lifehouse
Camperdown, 2050, Australia
St George Hospital
Kogarah, 2217, Australia
Cabrini Medical Centre
Malvern, 3144, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
UZ Leuven
Leuven, 3000, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Fundacao Pio XII
Barretos, 14784-400, Brazil
Cetus Oncologia
Belo Horizonte, 30110-017, Brazil
Ynova Pesquisa Clinica
Florianópolis, 88020-210, Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
Ijuí, 98700-000, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, 96020 080, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, 20231 050, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22 250 905, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, 22281 100, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, 04014-002, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-075, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim
Vitória, 29308-014, Brazil
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
Beijing, 100142, China
Beijing Cancer Hospital
Beijing, 100142, China
Chinese PLA General Hospital
Beijing, 100853, China
Beijing Chest hospital, Capital medical university
Beijing, 101199, China
Peking University International Hospital
Beijing, 102206, China
Jilin cancer hospital
Changchun, 130000, China
Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II
Changsha, 410013, China
Hunan Cancer hospital
Changsha, 410013, China
The First People's Hospital Of Changzhou
Changzhou, 213003, China
West China Hospital Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
The Second Affiliated Hospital of Zhejiang University College of Medicine 1
Hangzhou, 310009, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin medical university cancer hospital
Harbin, 150000, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
Nanjing Drum Tower Hospital
Nanjing, 210031, China
Shanghai Chest Hospital
Shanghai, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai East Hospital
Shanghai, 200123, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, 518116, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Weifang People's Hospital
Weifang, 261000, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
Hospital of Jiangnan University
Wuxi, 214122, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Institut Bergonie
Bordeaux, 33000, France
Hospices Civils de Lyon HCL
Bron, 69500, France
Centre Georges Francois Leclerc
Dijon, 21000, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
CHR Hôpital Calmette
Lille, 59037, France
CHU Nantes - Hopital Nord Laënnec
Nantes, 44093, France
Institut Curie
Paris, 75005, France
CHU Bordeaux
Pessac, 33604, France
HIA Begin
Saint-Mandé, 94163, France
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Kliniken der Stadt Koeln gGmbH
Cologne, 51109, Germany
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
Gauting, 82131, Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, 69126, Germany
Onkologische Schwerpunktpraxis
Heilbronn, 74072, Germany
Bethanien Krankenhaus
Moers, 47441, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
Oncologianova GmbH
Recklinghausen, 45659, Germany
Orszagos Koranyi Tbc es Pulmonologiai Intezet
Budapest, H-1529, Hungary
Mátrai Gyógyintézet-Bronchológia
Gyöngyös, 3233, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár, 8000, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, 9700, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Basavatarakam Indo-American Hospital
Hyderabad, 500034, India
Tata Medical Center
Kolkata, 700160, India
Tata Memorial Hospital
Mumbai, 400012, India
HCG Manavta Cancer Centre
Nashik, 422002, India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, 110085, India
Noble Hospital Pvt Ltd
Pune, 411013, India
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, 95123, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
San Gerardo Hospital
Monza, 20052, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Irccs Gemelli
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Juntendo University Hospital
Bunkyō City, 113 8431, Japan
Saitama Medical University International Medical Center
Hidaka, 350-1298, Japan
National Hospital Organization Himeji Medical Center
Himeji, 670-8520, Japan
Kansai Medical University Hospital
Hirakata, 573 1191, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Kishiwada City Hospital
Kishiwada, 596-8501, Japan
Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
Kurashiki Central Hospital
Kurashiki, 710-8602, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Matsusaka Municipal Hospital
Matsusaka, 515-8544, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
Aichi Cancer Center Hospital
Nagoya, 464 8681, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Kindai University Hospital
Osaka Sayama Shi, 589 8511, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
Shizuoka Cancer Center
Shizuoka, 411 8777, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Ehime University Hospital
Toon-shi, 791-0295, Japan
Wakayama Medical University Hospital
Wakayama, 641 8510, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi, 755-0241, Japan
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Centro Oncologico de Chihuahua
Chihuahua City, 31217, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Mexico Centre for Clinical Research, S.A. de C.V.
Mexico City, 03100, Mexico
Médica Sur
Mexico City, 14050, Mexico
Instituto Nacional de Cancerologia
Mexico City, 14080, Mexico
Health Pharma Professional Research
México, 03100, Mexico
i Can Oncology Center
Monterrey, 64710, Mexico
Oncologia Integral Satelite
Naucalpan, 53100, Mexico
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Szpitale Pomorskie Sp z o o
Gdynia, 81 519, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357, Poland
Private Specialist Hospitals - MedPolonia
Poznan, 60-693, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Hosp. Cuf Descobertas
Lisbon, 1998-018, Portugal
Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
Lisbon, G1R 2J6, Portugal
Centro Hospitalar Universitario do Porto, EPE
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia
Porto, 4200-072, Portugal
Centro Hospitalar de Vila Nova de Gaia Espinho E P E
Vila Nova de Gaia, 4434 502, Portugal
Pan American Center for Oncology Trials LLC
Rio Piedras, 00935, Puerto Rico
Irkutsk Regional Oncology Dispensary
Irkutsk, 664035, Russia
Moscow City Oncology Hospital № 62
Krasnogorsk, 143423, Russia
Krasnoyarsk Regional Oncology Dispensary
Krasnoyarsk, 660133, Russia
Leningrad Regional Oncology Dispensary
Kuzmolovsky, 188663, Russia
MCK
Moscow, 115533, Russia
City Clinical Hospital #1
Nal'chik, 360000, Russia
Nizhny Novgorod Regional Oncological Dispensary
Nizhny Novgorod, 603000, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Oncology Medical Clinics AV Medical group
Saint Petersburg, 196006, Russia
N.N. Petrov Research Institute Of Oncology
Saint Petersburg, 197758, Russia
Tomsk Cancer Research Institute
Tomsk, 634050, Russia
Bashkir State Medical University
Ufa, 450083, Russia
Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, 150054, Russia
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
National Cancer Center 1
Gyeonggi-do, 10408, South Korea
GyeongSang National University Hospital
Gyeongsangnam-do, 52727, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Inst. Cat. D'Oncologia-Badalona
Badalona, 08916, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, 08028, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Univ. de Burgos
Burgos, 09003, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, 833, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Songklanagarind Hospital, Prince of Songkla University
Songkhla, 90110, Thailand
Adana City Hospital
Adana, 01060, Turkey (Türkiye)
Başkent University Medical Faculty Adana Application and Research Center
Adana, 01250, Turkey (Türkiye)
Gazi University Hospital
Ankara, 6560, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 6800, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
Istanbul, 34098, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Izmir Medical Park Hospital
Izmir, 35580, Turkey (Türkiye)
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, 49102, Ukraine
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv, 02091, Ukraine
National Cancer Institute
Kyiv, 03022, Ukraine
Edinburgh Cancer Centre Western General
Edinburgh, EH4 2XU, United Kingdom
The Royal Marsden NHS Trust Chelsea
London, SW3 6JJ, United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton, SM2 5PT, United Kingdom
Related Publications (5)
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.
PMID: 42192224DERIVEDZhou 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.
PMID: 41671628DERIVEDSanborn 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.
PMID: 41184595DERIVEDKitazono 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.
PMID: 40922529DERIVEDZhou 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.
PMID: 37870976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Medical Director
- Organization
- Janssen Research & Development
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 4, 2020
Study Start
October 13, 2020
Primary Completion
May 3, 2023
Study Completion (Estimated)
August 2, 2027
Last Updated
June 8, 2026
Results First Posted
May 29, 2024
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
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