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

NCT ID: NCT04538664

Last Updated: 2025-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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EGFR Exon20ins Mutation NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Amivantamab

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

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

Pemetrexed

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Carboplatin

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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JNJ-61186372

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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City of Hope

Duarte, California, United States

Site Status

University of California Irvine

Orange, California, United States

Site Status

UCLA

Santa Monica, California, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, United States

Site Status

University Cancer And Blood Center LLC

Athens, Georgia, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Washington University Medical Center

St Louis, Missouri, United States

Site Status

Regional Cancer Care Associates LLC

East Brunswick, New Jersey, United States

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Langone Health at NYC University, NYU School of Medicine

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

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Providence Portland Medical Center

Portland, Oregon, United States

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Sanford Health

Sioux Falls, South Dakota, United States

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Texas Oncology Pa

Tyler, Texas, United States

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Utah Cancer Specialists

Salt Lake City, Utah, United States

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Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

Blue Ridge Cancer Care

Salem, Virginia, United States

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Chris O'Brien Lifehouse

Camperdown, , Australia

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St George Hospital

Kogarah, , Australia

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Cabrini Medical Centre

Malvern, , Australia

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Sir Charles Gairdner Hospital

Nedlands, , Australia

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UZ Leuven

Leuven, , Belgium

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Algemeen Ziekenhuis Delta

Roeselare, , Belgium

Site Status

CHU UCL Namur - Site Godinne

Yvoir, , Belgium

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Fundacao Pio XII

Barretos, , Brazil

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Cetus Oncologia

Belo Horizonte, , Brazil

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Ynova Pesquisa Clinica

Florianópolis, , Brazil

Site Status

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, , Brazil

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Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

Site Status

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, , Brazil

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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Site Status

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

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Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

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Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, , Brazil

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Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

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Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

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Núcleo de Pesquisa São Camilo

São Paulo, , Brazil

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IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, , Brazil

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Hospital Evangélico de Cachoeiro de Itapemirim

Vitória, , Brazil

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The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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McGill University Health Centre

Montreal, Quebec, Canada

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Beijing Cancer Hospital

Beijing, , China

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Chinese PLA General Hospital

Beijing, , China

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Beijing Chest hospital, Capital medical university

Beijing, , China

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Peking University International Hospital

Beijing, , China

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Jilin cancer hospital

Changchun, , China

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Hunan Cancer hospital

Changsha, , China

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The First People's Hospital Of Changzhou

Changzhou, , China

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West China Hospital Sichuan University

Chengdu, , China

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Chongqing University Cancer Hospital

Chongqing, , China

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Fujian Medical University Union Hospital

Fuzhou, , China

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The First Affiliated Hospital Sun Yat sen University

Guangzhou, , China

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The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, , China

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The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, , China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

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Zhejiang Cancer Hospital

Hangzhou, , China

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Harbin medical university cancer hospital

Harbin, , China

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Taizhou Hospital of Zhejiang Province

Linhai, , China

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Nanjing Drum Tower Hospital

Nanjing, , China

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Shanghai Chest Hospital

Shanghai, , China

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Fudan University Shanghai Cancer Center

Shanghai, , China

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Shanghai East Hospital

Shanghai, , China

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Shanghai Pulmonary Hospital

Shanghai, , China

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Shengjing Hospital Of China Medical University

Shenyang, , China

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Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, , China

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Tianjin Medical University General Hospital

Tianjin, , China

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Weifang People's Hospital

Weifang, , China

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

Wuhan, , China

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Hospital of Jiangnan University

Wuxi, , China

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The First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

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Yantai Yuhuangding Hospital

Yantai, , China

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Henan Cancer Hospital

Zhengzhou, , China

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Institut Bergonie

Bordeaux, , France

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Hospices Civils de Lyon HCL

Bron, , France

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Centre Georges Francois Leclerc

Dijon, , France

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Centre Hospitalier Le Mans

Le Mans, , France

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CHR Hôpital Calmette

Lille, , France

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CHU Nantes - Hopital Nord Laënnec

Nantes, , France

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Institut Curie

Paris, , France

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CHU Bordeaux

Pessac, , France

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HIA Begin

Saint-Mandé, , France

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Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

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Evangelische Lungenklinik Berlin

Berlin, , Germany

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Universitaetsklinikum Koeln

Cologne, , Germany

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Kliniken der Stadt Koeln gGmbH

Cologne, , Germany

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Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Gauting, , Germany

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Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, , Germany

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Onkologische Schwerpunktpraxis

Heilbronn, , Germany

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Bethanien Krankenhaus

Moers, , Germany

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Pius-Hospital Oldenburg

Oldenburg, , Germany

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Oncologianova GmbH

Recklinghausen, , Germany

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Orszagos Koranyi Tbc es Pulmonologiai Intezet

Budapest, , Hungary

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Mátrai Gyógyintézet-Bronchológia

Gyöngyös, , Hungary

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Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, , Hungary

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Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

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Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

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Basavatarakam Indo-American Hospital

Hyderabad, , India

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Tata Medical Center

Kolkata, , India

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Tata Memorial Hospital

Mumbai, , India

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HCG Manavta Cancer Centre

Nashik, , India

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Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, , India

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Noble Hospital Pvt Ltd

Pune, , India

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Shaare Zedek Medical Center

Jerusalem, , Israel

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Hadassah Medical Center

Jerusalem, , Israel

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Meir Medical Center

Kfar Saba, , Israel

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Rabin Medical Center

Petah Tikva, , Israel

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

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A O U Sant Orsola Malpighi

Bologna, , Italy

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Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, , Italy

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Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

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IRCCS Ospedale San Raffaele

Milan, , Italy

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

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San Gerardo Hospital

Monza, , Italy

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Ospedale S. Maria Delle Croci

Ravenna, , Italy

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Irccs Gemelli

Roma, , Italy

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Istituto Clinico Humanitas

Rozzano, , Italy

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Juntendo University Hospital

Bunkyō City, , Japan

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Saitama Medical University International Medical Center

Hidaka, , Japan

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National Hospital Organization Himeji Medical Center

Himeji, , Japan

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Kansai Medical University Hospital

Hirakata, , Japan

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Kanazawa University Hospital

Kanazawa, , Japan

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National Cancer Center Hospital East

Kashiwa, , Japan

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Kishiwada City Hospital

Kishiwada, , Japan

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Kobe City Medical Center General Hospital

Kobe, , Japan

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Kurashiki Central Hospital

Kurashiki, , Japan

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Kurume University Hospital

Kurume, , Japan

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Matsusaka Municipal Hospital

Matsusaka, , Japan

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National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

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Aichi Cancer Center Hospital

Nagoya, , Japan

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Niigata Cancer Center Hospital

Niigata, , Japan

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Kindai University Hospital

Osaka Sayama Shi, , Japan

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Kitasato University Hospital

Sagamihara, , Japan

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Hokkaido University Hospital

Sapporo, , Japan

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Iwate Medical University Hospital

Shiwa-gun, , Japan

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Shizuoka Cancer Center

Shizuoka, , Japan

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The Cancer Institute Hospital of JFCR

Tokyo, , Japan

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Ehime University Hospital

Toon-shi, , Japan

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Wakayama Medical University Hospital

Wakayama, , Japan

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National Hospital Organization Yamaguchi Ube Medical Center

Yamaguchi, , Japan

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Hospital Pulau Pinang

George Town, , Malaysia

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Hospital Sultan Ismail

Johor Bahru, , Malaysia

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Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

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University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Centro Oncologico de Chihuahua

Chihuahua City, , Mexico

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status

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

Mexico City, , Mexico

Site Status

Médica Sur

Mexico City, , Mexico

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Instituto Nacional de Cancerologia

Mexico City, , Mexico

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Health Pharma Professional Research

México, , Mexico

Site Status

i Can Oncology Center

Monterrey, , Mexico

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Oncologia Integral Satelite

Naucalpan, , Mexico

Site Status

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, , Poland

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Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

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Szpitale Pomorskie Sp z o o

Gdynia, , Poland

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Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, , Poland

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Private Specialist Hospitals - MedPolonia

Poznan, , Poland

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Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

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Hosp. Cuf Descobertas

Lisbon, , Portugal

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Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos

Lisbon, , Portugal

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Centro Hospitalar Universitario do Porto, EPE

Porto, , Portugal

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Instituto Portugues de Oncologia

Porto, , Portugal

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Centro Hospitalar de Vila Nova de Gaia Espinho E P E

Vila Nova de Gaia, , Portugal

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Pan American Center for Oncology Trials LLC

Rio Piedras, , Puerto Rico

Site Status

Irkutsk Regional Oncology Dispensary

Irkutsk, , Russia

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Moscow City Oncology Hospital № 62

Krasnogorsk, , Russia

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Krasnoyarsk Regional Oncology Dispensary

Krasnoyarsk, , Russia

Site Status

Leningrad Regional Oncology Dispensary

Kuzmolovsky, , Russia

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MCK

Moscow, , Russia

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City Clinical Hospital #1

Nal'chik, , Russia

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Nizhny Novgorod Regional Oncological Dispensary

Nizhny Novgorod, , Russia

Site Status

Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

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Oncology Medical Clinics AV Medical group

Saint Petersburg, , Russia

Site Status

N.N. Petrov Research Institute Of Oncology

Saint Petersburg, , Russia

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Tomsk Cancer Research Institute

Tomsk, , Russia

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Bashkir State Medical University

Ufa, , Russia

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Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, , Russia

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Inje University Haeundae Paik Hospital

Busan, , South Korea

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National Cancer Center

Gyeonggi-do, , South Korea

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GyeongSang National University Hospital

Gyeongsangnam-do, , South Korea

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Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

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Korea University Anam Hospital

Seoul, , South Korea

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Kangbuk Samsung Hospital

Seoul, , South Korea

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Severance Hospital Yonsei University Health System

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

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Hosp Univ A Coruna

A Coruña, , Spain

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Inst. Cat. D'Oncologia-Badalona

Badalona, , Spain

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Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

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Hosp. Univ. Quiron Dexeus

Barcelona, , Spain

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Hosp Univ Vall D Hebron

Barcelona, , Spain

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Hosp. Univ. de Burgos

Burgos, , Spain

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Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

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Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

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Hosp. Univ. 12 de Octubre

Madrid, , Spain

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Hosp. Univ. La Paz

Madrid, , Spain

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Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

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Hosp Virgen de La Victoria

Málaga, , Spain

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Clinica Univ. de Navarra

Pamplona, , Spain

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Hosp. Virgen Del Rocio

Seville, , Spain

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Hosp. Clinico Univ. Lozano Blesa

Zaragoza, , Spain

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Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

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Chang Gung Medical Foundation

Kaohsiung City, , Taiwan

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Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

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Chung Shan Medical University Hospital

Taichung, , Taiwan

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China Medical University Hospital

Taichung, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Phramongkutklao Hospital and Medical College

Bangkok, , Thailand

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Siriraj Hospital

Bangkok, , Thailand

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Songklanagarind Hospital, Prince of Songkla University

Songkhla, , Thailand

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Adana City Hospital

Adana, , Turkey (Türkiye)

Site Status

Başkent University Medical Faculty Adana Application and Research Center

Adana, , Turkey (Türkiye)

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Gazi University Hospital

Ankara, , Turkey (Türkiye)

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Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

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Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

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

Istanbul, , Turkey (Türkiye)

Site Status

Medipol Mega University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Izmir Medical Park Hospital

Izmir, , Turkey (Türkiye)

Site Status

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

Dnipro, , Ukraine

Site Status

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

Kyiv, , Ukraine

Site Status

National Cancer Institute

Kyiv, , Ukraine

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Edinburgh Cancer Centre Western General

Edinburgh, , United Kingdom

Site Status

The Royal Marsden NHS Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Trust

Sutton, , United Kingdom

Site Status

Countries

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United States Australia Belgium Brazil Canada China France Germany Hungary India Israel Italy Japan Malaysia Mexico Poland Portugal Puerto Rico Russia South Korea Spain Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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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 3. doi: 10.1007/s11523-025-01182-0. Online ahead of print.

Reference Type DERIVED
PMID: 41184595 (View on PubMed)

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 Sep 8. doi: 10.1111/cas.70180. Online ahead of print.

Reference Type DERIVED
PMID: 40922529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37870976 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

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Other Identifiers

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61186372NSC3001

Identifier Type: OTHER

Identifier Source: secondary_id

2020-000633-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506033-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108850

Identifier Type: -

Identifier Source: org_study_id