NCT06793215

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
600

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
55mo left

Started Oct 2025

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
28 countries

217 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Oct 2025Oct 2030

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

October 24, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

January 20, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

Advanced Non-Small Cell Lung CancerKRAS G12 Lung CancerAdvanced Lung CancerMetastatic lung cancerDivarasibKRAS G12C InhibitorKRAS G12C PositiveKRAS MutationKRAS G12C MutationLung Cancer Mutation

Outcome Measures

Primary Outcomes (2)

  • Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)

    Up to approximately 5 years

  • Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause

    Up to approximately 5 years

Secondary Outcomes (9)

  • Objective Response

    Up to approximately 5 years

  • Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale

    Baseline up to Cycle 5 Day 1 (each cycle is 21 days)

  • Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale

    Baseline up to Cycle 5 Day 1 (each cycle is 21 days)

  • Duration of Response (DOR)

    Up to approximately 5 years

  • Percentage of Participants with Adverse Events (AEs)

    Up to approximately 5 years

  • +4 more secondary outcomes

Study Arms (2)

Divarasib + Pembrolizumab

EXPERIMENTAL

Participants will receive divarasib orally, once daily (QD) and pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W)

Drug: DivarasibDrug: Pembrolizumab

Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin

ACTIVE COMPARATOR

Participants will receive pembrolizumab, pemetrexed and carboplatin or cisplatin via IV infusion Q3W

Drug: PembrolizumabDrug: PemetrexedDrug: CarboplatinDrug: Cisplatin

Interventions

Pembrolizumab will be administered via IV infusion Q3W

Divarasib + PembrolizumabPembrolizumab + Pemetrexed + Carboplatin or Cisplatin

Pemetrexed will be administered via IV infusion Q3W

Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin

Carboplatin will be administered via IV infusion Q3W

Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin

Cisplatin will be administered via IV infusion Q3W

Pembrolizumab + Pemetrexed + Carboplatin or Cisplatin

Divarasib will be administered orally QD

Divarasib + Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
  • Measurable disease, as defined by RECIST v1.1
  • No prior systemic treatment for advanced or metastatic NSCLC
  • Documentation of the presence of a KRAS G12C mutation
  • Documentation of known PD-L1 expression status in tumor tissue
  • Availability of a representative tumor specimen
  • Adequate end-organ function
  • Eligible to receive a platinum-based chemotherapy regimen

You may not qualify if:

  • Known concomitant second oncogenic driver with available targeted treatment
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
  • Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study
  • Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization
  • Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
  • Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
  • Current treatment with medications that are well known to prolong the QT interval
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
  • Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (217)

Alaska Oncology and Hematology

Anchorage, Alaska, 99508, United States

RECRUITING

City of Hope - Phoenix

Goodyear, Arizona, 85338, United States

RECRUITING

Marin Cancer Care Inc

Greenbrae, California, 94904, United States

RECRUITING

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

RECRUITING

Florida Cancer Specialists - SOUTH - SCRI - PPDS

Fort Myers, Florida, 33901-8108, United States

RECRUITING

BioResearch Partner

Hialeah, Florida, 33013, United States

RECRUITING

Ascension Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Florida Cancer Specialists - NORTH - SCRI - PPDS

St. Petersburg, Florida, 33701, United States

RECRUITING

Florida Cancer Specialists - EAST - SCRI - PPDS

West Palm Beach, Florida, 33401-3406, United States

RECRUITING

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

RECRUITING

City of Hope® Atlanta

Newnan, Georgia, 30265, United States

RECRUITING

Summit Cancer Care PC

Savannah, Georgia, 31405, United States

RECRUITING

St. Luke's Cancer Institute

Boise, Idaho, 83712, United States

RECRUITING

Affiliated Oncologists, LLC

Chicago Ridge, Illinois, 60415, United States

RECRUITING

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521, United States

WITHDRAWN

City of Hope® Cancer Center Chicago

Zion, Illinois, 60099, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Profound Research, LLC

Farmington Hills, Michigan, 48334, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

RECRUITING

Montefiore Einstein Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

Clinical Research Alliance

Westbury, New York, 11590, United States

RECRUITING

Firsthealth of The Carolinas

Pinehurst, North Carolina, 28374, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Reading Hospital - McGlinn Cancer Institute

West Reading, Pennsylvania, 19611, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

Renovatio Clinical - El Paso

El Paso, Texas, 79915, United States

RECRUITING

JPS Health Network

Fort Worth, Texas, 76104, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

RECRUITING

Community Clinical Trials

Kingwood, Texas, 77339, United States

RECRUITING

Texas Tech Health Science Center

Lubbock, Texas, 79415, United States

RECRUITING

Renovatio Clinical

The Woodlands, Texas, 77380, United States

RECRUITING

University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Hospital Britanico

Ciudad Autonoma Buenos Aires, C1280AEB, Argentina

RECRUITING

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

RECRUITING

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

RECRUITING

Kinghorn Cancer Centre

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Peter Maccallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

AZORG Campus Aalst-Moorselbaan

Aalst, 9300, Belgium

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

CHU de Liège (Sart Tilman)

Liège, 4000, Belgium

RECRUITING

CHU HELORA - Hôpital de Mons - Site Kennedy

Mons, 7000, Belgium

RECRUITING

AZ Delta (Campus Rumbeke)

Roeselare, 8800, Belgium

RECRUITING

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60336-232, Brazil

RECRUITING

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, 80810-050, Brazil

RECRUITING

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, 59040150, Brazil

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 90040-373, Brazil

RECRUITING

Fundação Pio XII Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

RECRUITING

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BC Cancer - Victoria

Victoria, British Columbia, V8R 6V5, Canada

RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

William Osler Health Centre - Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centre Hospitalier Regional De Rimouski

Rimouski, Quebec, G5L 5T1, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

RECRUITING

Hunan Cancer Hospital

Changsha, 410013, China

RECRUITING

West China Hospital - Sichuan University

Chengdu, 611130, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, 150081, China

RECRUITING

Shanghai East Hospital

Shanghai, 200120, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, 200433, China

RECRUITING

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

RECRUITING

Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed

Herlev, 2730, Denmark

RECRUITING

Rigshospitalet

København Ø, 2100, Denmark

RECRUITING

Sjællands Universitetshospital, Roskilde

Roskilde, 4000, Denmark

RECRUITING

Onkologisk Ambulatorium - Sønderborg

Sønderborg, 6400, Denmark

RECRUITING

CHU Angers

Angers, 49933, France

RECRUITING

Hopital Avicenne

Bobigny, 93009, France

RECRUITING

Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, 69677, France

RECRUITING

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

CHU Montpellier

Montpellier, 34295, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

Groupe Hospitalier Paris Saint Joseph

Paris, 75014, France

RECRUITING

Hopital Tenon

Paris, 75970, France

RECRUITING

CHU Bordeaux

Pessac, 33604, France

RECRUITING

Centre Hospitalier Universitaire de Reims

Reims, 51092, France

RECRUITING

CH de Saint Quentin

Saint-Quentin, 02321, France

RECRUITING

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

RECRUITING

Centre Hospitalier Bretagne Atlantique Vannes

Vannes, 56017, France

RECRUITING

Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und Palliativmedizin

Berlin, 10249, Germany

RECRUITING

Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

RECRUITING

KEM/Evang. Kliniken Essen Mitte gGmbH

Essen, 45136, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

RECRUITING

Asklepios Fachkliniken GmbH

Gauting, 82131, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, 06120, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

KRH Klinikum Siloah-Oststadt-Heidehaus

Hanover, 30459, Germany

RECRUITING

Universität Des Saarlandes

Homburg, 66421, Germany

RECRUITING

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

RECRUITING

Vincentius-Diakonissen-Kliniken gAG

Karlsruhe, 76137, Germany

RECRUITING

SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein

Löwenstein, 74245, Germany

RECRUITING

Universität Mannheim

Mannheim, 68167, Germany

RECRUITING

Pius Hospital Oldenburg

Oldenburg, 26121, Germany

RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Klinikum Würzburg Mitte gGmbH

Würzburg, 97074, Germany

RECRUITING

Sotiria General Hospital of Athens

Athens, 115 27, Greece

RECRUITING

Alexandras Hospital

Athens, 115 28, Greece

RECRUITING

Errikos Dynan Hospital

Athens, 11526, Greece

RECRUITING

University Hospital of Larissa

Larissa, 411 10, Greece

RECRUITING

Interbalkan Medical Center of Thessaloniki

Thessaloniki, 546 39, Greece

RECRUITING

Theageneion Anticancer Hospital

Thessaloniki, 54639, Greece

RECRUITING

Ag. Loukas Hospital

Thessaloniki, 55236, Greece

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Tuen Mun Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Elizabeth Hospital Department of Clinical Oncology

Kowloon, 000000, Hong Kong

RECRUITING

Prince of Wales Hosp

Shatin, Hong Kong

RECRUITING

Matrai Gyogyintezet

Mátraháza, 3233, Hungary

RECRUITING

Református Pulmonológiai Centrum

Törökbálint, 2045, Hungary

RECRUITING

St James Hospital

Dublin, D08 NHY1, Ireland

RECRUITING

Beaumont Hospital

Dublin, D09V2N0, Ireland

RECRUITING

Tallaght Hospital

Dublin, D24 NR0A, Ireland

RECRUITING

Mater Misecordiae University Hospital

Dublin, Dublin 7, Ireland

RECRUITING

Ospedale Giuseppe Moscati

Statte, Apulia, 74010, Italy

RECRUITING

AORN Ospedali dei Colli Ospedale Monaldi

Naples, Campania, 80131, Italy

RECRUITING

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Campania, 80131, Italy

RECRUITING

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, 41100, Italy

RECRUITING

Presidio san salvatore muraglia

Pesaro, Emilia-Romagna, 61122, Italy

RECRUITING

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00151, Italy

RECRUITING

Policlinico Universitario "Agostino Gemelli"

Rome, Lazio, 00168, Italy

RECRUITING

IEO Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

Milan, Lombardy, 20162, Italy

RECRUITING

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, 95045, Italy

RECRUITING

USL 6 Toscana Nord Ovest ? P.O. Livorno

Livorno, Tuscany, 57124, Italy

RECRUITING

Ospedale P. Pederzoli Casa di cura Privata

Peschiera Del Garda (VR), Veneto, 37019, Italy

RECRUITING

Kyushu University Hospital

Fukuoka, 812-8582, Japan

RECRUITING

Kurume University Hospital

Fukuoka, 830-0011, Japan

RECRUITING

Hyogo Medical University Hospital

Hyōgo, 663-8501, Japan

RECRUITING

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

RECRUITING

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

RECRUITING

Sendai Kousei Hospital

Miyagi, 981-0914, Japan

RECRUITING

Niigata University Medical & Dental Hospital

Niigata, 951-8520, Japan

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

RECRUITING

Kansai Medical University Hospital

Osaka, 573-1191, Japan

RECRUITING

Tohoku University Hospital

Sendai, 980-8574, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, 06700, Mexico

RECRUITING

Meander Medisch Centrum

Amersfoort, Utrecht, 3813 TZ, Netherlands

RECRUITING

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

RECRUITING

Ziekenhuis St. Jansdal

Harderwijk, 3844 DG, Netherlands

RECRUITING

Isala

Zwolle, 8025 AB, Netherlands

RECRUITING

Harbour Cancer and Wellness

Auckland, 1023, New Zealand

RECRUITING

Centrum Pulmonologii i Torakochirurgii

Bystra, 43-360, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

RECRUITING

Krakowski Szpital Specjalistyczny im sw.Jana Pawla II

Krakow, 31-202, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny nr 4 w Lublinie

Lublin, 20-954, Poland

RECRUITING

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, 10-357, Poland

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, 60-569, Poland

RECRUITING

Radomskie Centrum Onkologii

Radom, 26-600, Poland

RECRUITING

Instytut Gruzlicy I Chorob Pluc

Warsaw, 01-138, Poland

RECRUITING

Mazowiecki Szpital Onkologiczny

Wieliszew, 05-135, Poland

RECRUITING

Dolnoslaskie Centrum Chorob Pluc

Wroclaw, 53-439, Poland

RECRUITING

Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

RECRUITING

IPO do Porto

Porto, 4200-072, Portugal

RECRUITING

CHVNG/E_Unidade 1

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

National University Hospital

Singapore, 119228, Singapore

RECRUITING

National Cancer Centre

Singapore, 168583, Singapore

RECRUITING

Wits Donald Gordon Clinical Trial Centre

Parktown, South Africa

RECRUITING

Chris Hani Baragwanath Clinical Trial Site

Soweto, 2013, South Africa

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 8308, South Korea

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Clinica Universidad de Navarra Madrid

Madrid, 28027, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Kantonsspital Baden

Baden, 5404, Switzerland

RECRUITING

Universitaetsspital Basel

Basel, 4031, Switzerland

RECRUITING

Kantonsspital Graubünden Medizin Onkologie

Chur, 7000, Switzerland

RECRUITING

Hôpital Universitaire de Genève (HUG)

Geneva, 1211, Switzerland

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

RECRUITING

E-DA Hospital

Kaohsiung City, 824, Taiwan

RECRUITING

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 00100, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

National Taiwan University Cancer Center

Zhongzheng Dist., 106, Taiwan

RECRUITING

Blackpool Teaching Hospitals NHS Foundation Trust , Victoria Hospital

Blackpool, FY3 8NR, United Kingdom

RECRUITING

Bristol Haematology & Oncology Centre

Bristol, BS2 8ED, United Kingdom

RECRUITING

East Kent Hospitals University NHS Foundation Trust

Canterbury, CT1 3NG, United Kingdom

RECRUITING

Velindre NHS Trust - Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

RECRUITING

Barts and the London NHS Trust

London, E1 2ES, United Kingdom

RECRUITING

Royal Marsden Hospital - Fulham

London, SW3 6JJ, United Kingdom

RECRUITING

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

RECRUITING

Maidstone and Tunbridge Wells NHS Trust

Maidstone, ME16 9QQ, United Kingdom

RECRUITING

Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

pembrolizumabPemetrexedCarboplatinCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCoordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: CO45042 https://forpatients.roche.com/

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

October 24, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

October 31, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Locations