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ACTIVE NOT RECRUITING

NCT04655976

PHASE3

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Official title: A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

758

Start Date

2020-12-08

Completion Date

2027-03-30

Last Updated

2025-09-26

Healthy Volunteers

Conditions

Lung Cancer, Non-Small Cell

Interventions

BIOLOGICAL

Cobolimab

Cobolimab will be administered.

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

DRUG

Docetaxel

Docetaxel will be administered.

Inclusion Criteria: * Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma. * Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody. * Participant has measurable disease. * Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy. * Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry. * Participant has an ECOG performance status score of 0 or 1. * Participant has a life expectancy of at least 3 months. * Participant has adequate Baseline organ function. * Participant has recovered from any prior treatment related toxicities. * Participant agrees to use contraception. Exclusion Criteria: * Participant has been previously treated with an anti-PD-\[L\]1 or anti-programmed death-ligand 2 (anti-PD-\[L\]2) agent that resulted in permanent discontinuation due to an AE. * Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel. * Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations. * Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) \<=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan. * Participant has received radiation to the lung that is \>30 gray (Gy) within 6 months prior to the first dose of study treatment. * Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment. * Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) \>2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) \>1.5 times ULN concomitant with alkaline phosphatase (ALP) \>2.5 times ULN; c. Bilirubin \>1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment). * Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment. * Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study. * Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies). * Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. * Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible. * Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management. * Participant has pre-existing peripheral neuropathy that is Grade \>=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria. * Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines. * Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose \<=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Locations (163)

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Norwich, Connecticut, United States

GSK Investigational Site

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

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Edgewood, Kentucky, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Mineola, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

White Plains, New York, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Sioux Falls, South Dakota, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Fredericksburg, Virginia, United States

GSK Investigational Site

Tacoma, Washington, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Cipoletti Rio Negro, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

La Rioja, Argentina

GSK Investigational Site

Pergamino, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Viedma, Argentina

GSK Investigational Site

South Brisbane, Queensland, Australia

GSK Investigational Site

Ashford, South Australia, Australia

GSK Investigational Site

Hobart, Tasmania, Australia

GSK Investigational Site

Ballarat, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Mount Waverley, Victoria, Australia

GSK Investigational Site

Aalst, Belgium

GSK Investigational Site

Hasselt, Belgium

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Kortrijk, Belgium

GSK Investigational Site

Blumenau, Brazil

GSK Investigational Site

Fortaleza, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

GSK Investigational Site

Salvador, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Kingston, Ontario, Canada

GSK Investigational Site

Oshawa, Ontario, Canada

GSK Investigational Site

Greenfield Park, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Kuopio, Finland

GSK Investigational Site

Créteil, France

GSK Investigational Site

Grenoble, France

GSK Investigational Site

Marseille, France

GSK Investigational Site

Nice, France

GSK Investigational Site

Quimper, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Tours, France

GSK Investigational Site

Augsburg, Germany

GSK Investigational Site

Bad Berka, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Bonn, Germany

GSK Investigational Site

Cologne, Germany

GSK Investigational Site

Dresden, Germany

GSK Investigational Site

Essen, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Frankfurt, Germany

GSK Investigational Site

Halle, Germany

GSK Investigational Site

Heidelberg, Germany

GSK Investigational Site

Karlsruhe, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Oldenburg, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Pylaia Thessaloniki, Greece

GSK Investigational Site

Rio Patras, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Ancona, Italy

GSK Investigational Site

Avellino, Italy

GSK Investigational Site

Florence, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Monza, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Orbassano to, Italy

GSK Investigational Site

Perugia, Italy

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Siena, Italy

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Miyagi, Japan

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Osaka, Japan

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Yamaguchi, Japan

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Monterrey, Mexico

GSK Investigational Site

Puebla Puebla, Mexico

GSK Investigational Site

Amersfoort, Netherlands

GSK Investigational Site

Enschede, Netherlands

GSK Investigational Site

Groningen, Netherlands

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Harderwijk, Netherlands

GSK Investigational Site

Nijmegen, Netherlands

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Utrecht, Netherlands

GSK Investigational Site

Zwolle, Netherlands

GSK Investigational Site

Bydgoszcz, Poland

GSK Investigational Site

Gdynia, Poland

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Lodz, Poland

GSK Investigational Site

Olsztyn, Poland

GSK Investigational Site

Piła, Poland

GSK Investigational Site

Poznan, Poland

GSK Investigational Site

Bucharest, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Craiova Dolj, Romania

GSK Investigational Site

Otopeni, Romania

GSK Investigational Site

Timișoara, Romania

GSK Investigational Site

Chelyabinsk, Russia

GSK Investigational Site

Moscow Region, Russia

GSK Investigational Site

Pushkin, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Cheongju Chungcheongbuk-do, South Korea

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Gyeonggi-do, South Korea

GSK Investigational Site

Pusan, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Kyunggi-do, South Korea

GSK Investigational Site

A Coruña, Spain

GSK Investigational Site

Badalona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Burgos, Spain

GSK Investigational Site

Córdoba, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

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Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Valencia, Spain

GSK Investigational Site

Gävle, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Uppsala, Sweden

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Dusit, Thailand

GSK Investigational Site

Kho Hong Hat Yai, Thailand

GSK Investigational Site

Khon Kaen, Thailand

GSK Investigational Site

Pathum Thani, Thailand

GSK Investigational Site

Adana, Turkey (Türkiye)

GSK Investigational Site

Antalya, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

GSK Investigational Site

Cardiff, United Kingdom

GSK Investigational Site

Edinburgh, United Kingdom

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London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Manchester, United Kingdom

Clinical Research Directory

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)