A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT ID: NCT04988295

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

776 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2026-09-30

Brief Summary

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The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

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: LACP/ACP-L

LACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.

Group Type EXPERIMENTAL

Lazertinib

Intervention Type DRUG

Lazertinib will be administered orally.

Amivantamab

Intervention Type DRUG

Amivantamab will be administered as an IV infusion.

Pemetrexed

Intervention Type DRUG

Pemetrexed will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Arm B: CP (Carboplatin and Pemetrexed)

Participants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

Pemetrexed will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)

Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.

Group Type EXPERIMENTAL

Amivantamab

Intervention Type DRUG

Amivantamab will be administered as an IV infusion.

Pemetrexed

Intervention Type DRUG

Pemetrexed will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Arm A2 (Extension Cohort): ACP-L

Participants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.

Group Type EXPERIMENTAL

Lazertinib

Intervention Type DRUG

Lazertinib will be administered orally.

Amivantamab

Intervention Type DRUG

Amivantamab will be administered as an IV infusion.

Pemetrexed

Intervention Type DRUG

Pemetrexed will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Arm C2 (Extension Cohort): ACP

Participants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.

Group Type EXPERIMENTAL

Amivantamab

Intervention Type DRUG

Amivantamab will be administered as an IV infusion.

Pemetrexed

Intervention Type DRUG

Pemetrexed will be administered as an IV infusion.

Carboplatin

Intervention Type DRUG

Carboplatin will be administered as an IV infusion.

Interventions

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Lazertinib

Lazertinib will be administered orally.

Intervention Type DRUG

Amivantamab

Amivantamab will be administered as an IV infusion.

Intervention Type DRUG

Pemetrexed

Pemetrexed will be administered as an IV infusion.

Intervention Type DRUG

Carboplatin

Carboplatin will be administered as an IV infusion.

Intervention Type DRUG

Other Intervention Names

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JNJ-73841937 YH-25448 JNJ-61186372

Eligibility Criteria

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Inclusion Criteria

* Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
* A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
* Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement)
* A participant of childbearing potential must have a negative serum pregnancy 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
* Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

Exclusion Criteria

* Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
* Participant with symptomatic or progressive brain metastases
* Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
* Participant has known small cell transformation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines
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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Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Adana City Hospital

Adana, , Turkey (Türkiye)

Site Status

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Gazi University Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Southern Cancer Center, PC

Mobile, Alabama, United States

Site Status

Arizona Oncology Associates

Tucson, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

University of California Irvine

Orange, California, United States

Site Status

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Site Status

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, United States

Site Status

University Cancer And Blood Center LLC

Athens, Georgia, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Nebraska Cancer Specialists

Grand Island, Nebraska, United States

Site Status

Astera Cancer Care

East Brunswick, New Jersey, United States

Site Status

TriHealth Network

Cincinnati, Ohio, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Alliance Cancer Specialists

Horsham, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status

Texas Oncology-Medical City Dallas

Dallas, Texas, United States

Site Status

Texas Oncology Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

Site Status

Texas Oncology

Grapevine, Texas, United States

Site Status

Oncology Consultants Texas

Houston, Texas, United States

Site Status

Texas Oncology - Northeast

Longview, Texas, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

Blue Ridge Cancer Care

Wytheville, Virginia, United States

Site Status

NorthWest Medical Specialties, PLLC

Puyallup, Washington, United States

Site Status

Compass Oncology

Vancouver, Washington, United States

Site Status

CINME Centro de Investigaciones Metabolicas

Caba, , Argentina

Site Status

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, , Argentina

Site Status

Centro Medico Fleischer

CABA, , Argentina

Site Status

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

CABA, , Argentina

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Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, , Argentina

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Hospital Privado Universitario De Cordoba

Córdoba, , Argentina

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Hospital Privado de la Comunidad

Mar del Plata, , Argentina

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Clínica Viedma

Viedma, , Argentina

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Grand Hopital De Charleroi Site Les Viviers

Charleroi, , Belgium

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UZA

Edegem, , Belgium

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UZ Gent

Ghent, , Belgium

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Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

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UZ Leuven

Leuven, , Belgium

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CHU Sart-Tilman

Liège, , Belgium

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Clinique Saint Pierre

Ottignies, , Belgium

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Cetus Oncologia

Belo Horizonte, , Brazil

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CIONC Centro Integrado de Oncologia de Curitiba

Curitiba, , Brazil

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Ynova Pesquisa Clinica

Florianópolis, , Brazil

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Fundacao Sao Francisco Xavier

Ipatinga, , Brazil

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UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, , Brazil

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Associacao Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

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Hospital Ernesto Dornelles

Porto Alegre, , 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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Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, , Brazil

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Nucleo de Oncologia da Bahia

Salvador, , Brazil

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Hospital Sao Rafael

Salvador, , Brazil

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CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, , Brazil

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Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, , Brazil

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Hospital Paulistano

São Paulo, , Brazil

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Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

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Hospital Nove de Julho

São Paulo, , Brazil

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Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

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Onco Star SP Oncologia Ltda

São Paulo, , Brazil

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IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, , Brazil

Site Status

COT - Centro Oncologico do Triangulo S.A

Uberlândia, , Brazil

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Multifunctional Hospital for Active Treatment 'Serdika'

Sofia, , Bulgaria

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Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, , Bulgaria

Site Status

Specialized Hospital for Active Treatment in Oncology

Sofia, , Bulgaria

Site Status

UMHAT Sofia Med

Sofia, , Bulgaria

Site Status

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

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British Columbia Cancer Agency

Vancouver, British Columbia, Canada

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McGill University Health Centre

Montreal, Quebec, Canada

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

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Peking University People s Hospital

Beijing, , China

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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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Hunan Cancer hospital

Changsha, , China

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Sichuan Cancer Hospital

Chengdu, , 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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Southwest Hospital

Chongqing, , China

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The First Affiliated Hospital Sun Yat sen University

Guangzhou, , China

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Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, , China

Site Status

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, , China

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The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, , China

Site Status

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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Huizhou Municipal Central Hospital

Huizhou, , China

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Taizhou Hospital of Zhejiang Province

Linhai, , China

Site Status

Affiliated Hospital of North Sichuan Medical College

Nanchong, , China

Site Status

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, , China

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Shanghai East Hospital

Shanghai, , China

Site Status

Shenzhen university General Hospital

Shenzhen, , China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Shenzhen, , China

Site Status

Tianjin Medical University General Hospital

Tianjin, , China

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Weifang People's Hospital

Weifang, , 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

Site Status

Daping Hospital Army Characteristic Medical Center

Yuzhong District, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Fakultni nemocnice Olomouc - I.P.Pavlova 6

Olomouc, , Czechia

Site Status

Vitkovicka nemocnice a.s.

Ostrava- Vitkovice, , Czechia

Site Status

Fakultni nemocnice Plzen

Pilsen, , Czechia

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Institut Sainte Catherine

Avignon, , France

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Hospices Civils de Lyon HCL

Bron, , France

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CHU de Grenoble Hopital Albert Michallon

La Tronche, , France

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Centre Hospitalier du Mans

Le Mans, , France

Site Status

CHR Hôpital Calmette

Lille, , France

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Hopital Nord

Marseille, , France

Site Status

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, , France

Site Status

Institut Curie

Paris, , France

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CHU Bordeaux

Pessac, , France

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CHRU Hopital de Pontchaillou

Rennes, , France

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CHU Nantes

Sain-Herblain, , France

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Nouvel Hopital Civil - CHU Strasbourg

Strasbourg, , France

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CHU Bretonneau

Tours, , France

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Evangelische Lungenklinik Berlin

Berlin, , Germany

Site Status

Asklepios Klinikum Harburg

Hamburg, , Germany

Site Status

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Onkologische Schwerpunktpraxis

Heilbronn, , Germany

Site Status

POIS Sachsen GmbH iG

Leipzig, , Germany

Site Status

Bethanien Krankenhaus

Moers, , Germany

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Klinikum der Universitaet Muenchen

München, , Germany

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Oncologianova GmbH

Recklinghausen, , Germany

Site Status

Universitaetsklinikum Regensburg

Regensburg, , Germany

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

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Health Care Global Enterprises pvt Ltd

Bangalore, , India

Site Status

Artemis Hospital

Gurugram, , India

Site Status

Tata Medical Center

Kolkata, , India

Site Status

Tata Memorial Hospital

Mumbai, , India

Site Status

HCG Manavta Cancer Centre

Nashik, , India

Site Status

Rajiv Gandhi Cancer Institute and Research Centre

New Delh, , India

Site Status

Noble Hospital Pvt Ltd

Pune, , India

Site Status

Bhaktivedanta Hospital & Research Institute

Thāne, , India

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Rambam Health Corporation

Haifa, , Israel

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

CRO IRCCS Istituto Nazionale Tumori

Aviano, , Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Site Status

Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Azienda Ospedaliero-Universitaria Di Parma

Parma, , Italy

Site Status

Ospedale S. Maria Delle Croci

Ravenna, , Italy

Site Status

Istituto Nazionale Tumori Regina Elena

Roma, , Italy

Site Status

Policlinico G.B.Rossi

Verona, , Italy

Site Status

National Hospital Organization Shibukawa Medical Center

Gunma, , Japan

Site Status

Hyogo Cancer Center

Hyōgo, , Japan

Site Status

Kanagawa Cancer Center

Kanagawa, , Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, , Japan

Site Status

Kurume University Hospital

Kurume, , Japan

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Site Status

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status

Ehime University Hospital

Toon-shi, , Japan

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Wakayama Medical University Hospital

Wakayama, , Japan

Site Status

National Hospital Organization Iwakuni Clinical Center

Yamaguchi, , Japan

Site Status

National Hospital Organization Yamaguchi Ube Medical Center

Yamaguchi, , Japan

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Site Status

Beacon Hospital Sdn Bhd

Petaling Jaya, , Malaysia

Site Status

Subang Jaya Medical Centre

Subang Jaya, , Malaysia

Site Status

Mount Miriam Cancer Hospital

Tanjung Bungah, , Malaysia

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status

CIMOVA, Morals Vargas Centro de Investigación SC

León, , Mexico

Site Status

Health Pharma Professional Research

México, , Mexico

Site Status

Instituto Nacional de Cancerologia

México, , Mexico

Site Status

Oncologia Integral Satelite

Naucalpan, , Mexico

Site Status

VUMC Amsterdam

Amsterdam, , Netherlands

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Ziekenhuis St Jansdal

Harderwijk, , Netherlands

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, , Poland

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Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

Szpitale Pomorskie Sp z o o

Gdynia, , Poland

Site Status

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, , Poland

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Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

Poznan, , Poland

Site Status

Private Specialist Hospitals - MedPolonia

Poznan, , Poland

Site Status

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

Uls Santa Maria - Hosp. Pulido Valente

Lisbon, , Portugal

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Uls Loures Odivelas - Hosp. Loures

Loures, , Portugal

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Uls Santo Antonio - Hosp. Santo Antonio

Porto, , Portugal

Site Status

Instituto Portugues de Oncologia

Porto, , Portugal

Site Status

Pan American Center for Oncology Trials LLC

Rio Piedras, , Puerto Rico

Site Status

City Clinical Hospital #1

Nal'chik, , Russia

Site Status

Llc, Eurocityclinic

Saint Petersburg, , Russia

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

Site Status

CHA Bundang Medical Center, CHA University

Gyeonggi-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

GyeongSang National University Hospital

Gyeongsangnam-do, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

Site Status

Hosp Univ A Coruna

A Coruña, , Spain

Site Status

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Site Status

Hosp. Univ. Quiron Dexeus

Barcelona, , Spain

Site Status

Hosp Univ Vall D Hebron

Barcelona, , Spain

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Hosp Clinic de Barcelona

Barcelona, , Spain

Site Status

Hosp. Univ. Insular de Gran Canaria

Las Palmas de Gran Canaria, , Spain

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Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

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Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

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Hosp. Univ. La Paz

Madrid, , Spain

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Hosp Univ Hm Sanchinarro

Madrid, , Spain

Site Status

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

Site Status

Hosp Regional Univ de Malaga

Málaga, , Spain

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Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp. Virgen Del Rocio

Seville, , Spain

Site Status

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Site Status

Hosp. Univ. I Politecni La Fe

Valencia, , Spain

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Linkoping University Hospital

Linköping, , Sweden

Site Status

Skanes universitetssjukhus

Lund, , Sweden

Site Status

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

Bakirkoy Training and Research Hospital

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

Medical Point

Izmir, , Turkey (Türkiye)

Site Status

Velindre Hospital

Cardiff, , United Kingdom

Site Status

Edinburgh Cancer Centre Western General

Edinburgh, , United Kingdom

Site Status

UCL Cancer Institute

London, , United Kingdom

Site Status

Guys and St Thomas NHS Foundation Trust

London, , United Kingdom

Site Status

The Royal Marsden NHS Trust

London, , United Kingdom

Site Status

The Christie Nhs Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil Bulgaria Canada China Czechia Denmark France Germany Hong Kong India Israel Italy Japan Malaysia Mexico Netherlands Poland Portugal Puerto Rico Russia South Korea Spain Sweden Taiwan Turkey (Türkiye) United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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61186372NSC3002

Identifier Type: OTHER

Identifier Source: secondary_id

2021-001825-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506518-33-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109061

Identifier Type: -

Identifier Source: org_study_id