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)

April 23, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Approved 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
      • Florianopolis, Brazil, 88020-210
        • YNOVA Pesquisa Clinica
      • Ijui, 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, 90610-000
        • Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS
      • Porto Alegre, Brazil, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Rio De Janeiro, Brazil, 20231 050
        • Ministerio da Saude - Instituto Nacional do Cancer
      • 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)
      • Sao Paulo, Brazil, 01246-000
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • Sao Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa São Camilo
      • Sao Paulo, Brazil, 01509 900
        • Fundacao Antonio Prudente A C Camargo Cancer Center
      • Sorocaba, Brazil, 18030-075
        • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
      • Vitoria, Brazil, 29308-014
        • Hospital Evangélico 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
      • Changchun, China, 130000
        • Jilin Cancer Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • 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
      • Guang Zhou, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
      • Hang Zhou, China, 310022
        • Zhejiang Cancer Hospital
      • 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
      • Hangzhou, China, 310003
        • The First Affiliated Hospital Zhejiang University College of Medicine
      • 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 Bergonié
      • Bron, France, 69500
        • Hospices Civils de Lyon HCL
      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Lille CEDEX, France, 59037
        • CHR Hôpital Calmette
      • NANTES cedex 1, France, 44093
        • CHU Nantes - Hopital Nord Laënnec
      • Paris, France, 75005
        • Institut Curie
      • Pessac, France, 33604
        • CHU Bordeaux
      • Saint Mande, France, 94163
        • HIA Begin
      • le mans Cedex 9, France, 72037
        • Centre Hospitalier Le Mans
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH
      • Berlin, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Gauting, Germany, 82131
        • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
      • Heidelberg, Germany, 69126
        • Thoraxklinik am Universitatsklinikum Heidelberg
      • Heilbronn, Germany, 74072
        • Onkologische Schwerpunktpraxis
      • Koeln, Germany, 50937
        • Universitaetsklinikum Koeln
      • Koeln, Germany, 51109
        • Kliniken der Stadt Koeln gGmbH
      • 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
      • Szekesfehervar, Hungary, 8000
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Szombathely, Hungary, 9700
        • Markusovszky Egyetemi Oktatokorhaz
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
  • India
      • Hyderabad, India, 500034
        • Basavatarakam Indo-American Hospital
      • Kolkata, India, 700160
        • Tata Medical Center
      • Mumbai, India, 400012
        • Tata Memorial Hospital
      • Nasik, 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
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • 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
      • Bunkyo Ku, 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-Shi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Nagoya-shi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
      • 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-shi, 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
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Gyeongsangnam-do, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
  • 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, Mexico, 31217
        • Centro Oncológico de Chihuahua
      • Ciudad de Mexico, Mexico, 03100
        • Mexico Centre for Clinical Research, S.A. de C.V.
      • Ciudad de Mexico, Mexico, 14050
        • Médica Sur
      • Ciudad de Mexico, Mexico, 14080
        • Instituto Nacional de Cancerologia
      • Guadalajara, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Mexico, Mexico, 03100
        • Health Pharma Professional Research
      • Monterrey, Mexico, 64710
        • i Can Oncology Center
      • 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
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
  • Portugal
      • Lisboa, Portugal, 1998-018
        • Hosp. Cuf Descobertas
      • Lisboa, Portugal, G1R 2J6
        • Chlc - Hosp. Sto Antonio Dos Capuchos
      • 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
  • Russian Federation
      • Irkutsk, Russian Federation, 664035
        • Irkutsk Regional Oncology Dispensary
      • Krasnogorsk, Russian Federation, 143423
        • Moscow City Oncology Hospital № 62
      • Krasnoyarsk, Russian Federation, 660133
        • Krasnoyarsk Regional Oncology Dispensary
      • Kuzmolovsky, Russian Federation, 188663
        • Leningrad Regional Oncology Dispensary
      • Moscow, Russian Federation, 115533
        • MCK
      • Nalchik, Russian Federation, 360000
        • City Clinical Hospital #1
      • Nizhniy Novgorod, Russian Federation, 603000
        • Nizhny Novgorod Regional Oncological Dispensary
      • Saint Petersburg, Russian Federation, 197758
        • N.N. Petrov Research Institute Of Oncology
      • Saint-Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • St-Petersburg, Russian Federation, 196006
        • Oncology Medical Clinics AV Medical group
      • Tomsk, Russian Federation, 634050
        • Tomsk Cancer Research Institute
      • Ufa, Russian Federation, 450083
        • Bashkir State Medical University
      • Yaroslavl, Russian Federation, 150054
        • Yaroslavl Regional Clinical Oncology Hospital
  • Spain
      • A Coruna, Spain, 15006
        • Hosp. Univ. A Coruna
      • Badalona, Spain, 08916
        • Inst. Cat. D'Oncologia-Badalona
      • Barcelona, Spain, 08035
        • Hosp. Univ. Vall D Hebron
      • Barcelona, Spain, 08025
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Hosp. Univ. Quiron Dexeus
      • 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, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 833
        • Chang Gung Medical Foundation
      • New Taipei, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 402
        • Chung Shan Medical University Hospital
      • Taipei City, Taiwan, 10002
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital and Medical College
      • Songkla, Thailand, 90110
        • Songklanagarind Hospital, Prince of Songkla University
  • Turkey
      • Adana, Turkey, 01060
        • Adana City Hospital
      • Adana, Turkey, 01250
        • Başkent University Medical Faculty Adana Application and Research Center
      • Ankara, Turkey, 6560
        • Gazi University Hospital
      • Ankara, Turkey, 6800
        • Ankara Bilkent City Hospital
      • Edirne, Turkey, 22030
        • Trakya University Medical Faculty
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
      • Istanbul, Turkey, 34214
        • Medipol Mega University Hospital
      • Istanbul, Turkey, 34722
        • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
      • Izmir, Turkey, 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
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Trust
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Orange, California, United States, 92868
        • University of California Irvine
      • Santa Monica, California, United States, 90404
        • UCLA
    • District of Columbia
      • Washington, 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 & Blood Center, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • Saint 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

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
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 RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to 18 months
PFS is defined as the time from randomization until the date of objective disease progression based on blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death (by any cause) in the absence of progression, whichever comes first.
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 48 months
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
Up to 48 months
Overall Survival (OS)
Time Frame: Up to 48 months
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
Up to 48 months
Duration of Response (DoR)
Time Frame: Up to 48 months
DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria.
Up to 48 months
Time to Subsequent Therapy (TST)
Time Frame: Up to 48 months
TST is defined as the time from the date of randomization to the start date of the subsequent anti-cancer therapy following study treatment discontinuation, or death.
Up to 48 months
Progression-Free Survival After First Subsequent Therapy (PFS2)
Time Frame: Up to 48 months
PFS2 is defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the primary variable PFS or death after starting the next line of treatment.
Up to 48 months
Time to Symptomatic Progression (TTSP)
Time Frame: Up to 48 months
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms.
Up to 48 months
Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 48 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 48 months
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 48 months
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.
Up to 48 months
Number of Participants with Vital Signs Abnormalities
Time Frame: Up to 48 months
Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.
Up to 48 months
Number of Participants with Physical Examination Abnormalities
Time Frame: Up to 48 months
Number of participants with physical examination abnormalities will be reported.
Up to 48 months
Serum Concentration of Amivantamab
Time Frame: Up to 48 months
Serum samples will be analyzed to determine concentrations of amivantamab.
Up to 48 months
Number of Participants with Anti-Amivantamab Antibodies
Time Frame: Up to 48 months
Number of participants with antibodies to amivantamab will be reported.
Up to 48 months
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Time Frame: Up to 48 months
The EORTC QLQ-C30 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
Up to 48 months
Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
Time Frame: Up to 48 months
PROMIS-PF is used to characterize and better understand overall health, level of physical disability, and general well-being. Physical function is a foundation for commonly used general and cancer-specific patient reported outcomes (PRO) measures.
Up to 48 months

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

Investigators

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

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)

October 13, 2020

Primary Completion (Actual)

May 3, 2023

Study Completion (Estimated)

January 31, 2026

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)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Amivantamab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe