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

NCT04655976 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2134102020-003433-37
• Study Type: interventional
• Target: 758
• Locations: 24 countries
• Sites: 163

Brief 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.

Conditions

Lung Cancer, Non-Small Cell

Keywords

GSK4069889A; GSK4057190A; Cobolimab; Dostarlimab; Docetaxel; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone

  OS is defined as survival from the date of randomization to the date of death by any cause.

  Up to approximately 52 months

• OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone

  OS is defined as survival from the date of randomization to the date of death by any cause.

  Up to approximately 52 months

Secondary Outcomes (16)

• OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel

  Up to approximately 52 months

• Objective response rate (ORR)

  Up to approximately 52 months

• Progression free survival (PFS)

  Up to approximately 52 months

• Duration of response (DOR)

  Up to approximately 52 months

• Time to deterioration (TTD)

  Up to approximately 52 months

Study Arms (3)

Participants receiving cobolimab+ dostarlimab+ docetaxel

EXPERIMENTAL

Biological: Cobolimab; Biological: Dostarlimab; Drug: Docetaxel

Participants receiving dostarlimab+ docetaxel

EXPERIMENTAL

Biological: Dostarlimab; Drug: Docetaxel

Participants receiving docetaxel

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

Cobolimab BIOLOGICAL

Cobolimab will be administered.

Participants receiving cobolimab+ dostarlimab+ docetaxel

Dostarlimab BIOLOGICAL

Dostarlimab will be administered.

Participants receiving cobolimab+ dostarlimab+ docetaxel; Participants receiving dostarlimab+ docetaxel

Docetaxel DRUG

Docetaxel will be administered.

Participants receiving cobolimab+ dostarlimab+ docetaxel; Participants receiving docetaxel; Participants receiving dostarlimab+ docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (163)

GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Walnut Creek, California, 94596, United States

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GSK Investigational Site

Norwich, Connecticut, 06360, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20422, United States

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GSK Investigational Site

Honolulu, Hawaii, 96819, United States

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GSK Investigational Site

Iowa City, Iowa, 52242, United States

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GSK Investigational Site

Edgewood, Kentucky, 41017, United States

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GSK Investigational Site

Las Vegas, Nevada, 89144, United States

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GSK Investigational Site

Mineola, New York, 11501, United States

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GSK Investigational Site

New York, New York, 10016, United States

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GSK Investigational Site

White Plains, New York, 10601, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15224, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

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GSK Investigational Site

Sioux Falls, South Dakota, 57105, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Fredericksburg, Virginia, 22408, United States

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GSK Investigational Site

Tacoma, Washington, 98405, United States

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GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

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GSK Investigational Site

Cipoletti Rio Negro, R8324CVE, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1425, Argentina

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GSK Investigational Site

Florida, 1602, Argentina

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GSK Investigational Site

La Rioja, F5300COE, Argentina

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GSK Investigational Site

Pergamino, B2700CPM, Argentina

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GSK Investigational Site

Rosario, S2000DBS, Argentina

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GSK Investigational Site

Viedma, R8500ACE, Argentina

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GSK Investigational Site

South Brisbane, Queensland, 4101, Australia

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GSK Investigational Site

Ashford, South Australia, 5037, Australia

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GSK Investigational Site

Hobart, Tasmania, 7000, Australia

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GSK Investigational Site

Ballarat, Victoria, 3350, Australia

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GSK Investigational Site

Melbourne, Victoria, 3004, Australia

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GSK Investigational Site

Mount Waverley, Victoria, 3350, Australia

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GSK Investigational Site

Aalst, 9300, Belgium

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GSK Investigational Site

Hasselt, 3500, Belgium

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GSK Investigational Site

Kortrijk, 8500, Belgium

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GSK Investigational Site

Blumenau, 89010340, Brazil

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GSK Investigational Site

Fortaleza, 60336-232, Brazil

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GSK Investigational Site

Porto Alegre, 90610000, Brazil

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GSK Investigational Site

Rio de Janeiro, 22061080, Brazil

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GSK Investigational Site

Rio de Janeiro, 22250-905, Brazil

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GSK Investigational Site

Salvador, 40170-110, Brazil

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GSK Investigational Site

São Paulo, 04014-002, Brazil

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GSK Investigational Site

Greater Sudbury, Ontario, P3E 5J1, Canada

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GSK Investigational Site

Kingston, Ontario, K7L 2V7, Canada

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GSK Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

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GSK Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

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GSK Investigational Site

Montreal, Quebec, H3T 1E2, Canada

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GSK Investigational Site

Helsinki, 00180, Finland

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GSK Investigational Site

Kuopio, 70210, Finland

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GSK Investigational Site

Créteil, 94010, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

Marseille, 13009, France

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GSK Investigational Site

Nice, 06189, France

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GSK Investigational Site

Quimper, 29107, France

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GSK Investigational Site

Rennes, 35033, France

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GSK Investigational Site

Tours, 37044, France

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GSK Investigational Site

Augsburg, 86156, Germany

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GSK Investigational Site

Bad Berka, 99437, Germany

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GSK Investigational Site

Berlin, 12200, Germany

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GSK Investigational Site

Bonn, 53113, Germany

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GSK Investigational Site

Cologne, 51109, Germany

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GSK Investigational Site

Dresden, 01307, Germany

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GSK Investigational Site

Essen, 45147, Germany

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GSK Investigational Site

Frankfurt, 60488, Germany

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GSK Investigational Site

Frankfurt, 60590, Germany

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GSK Investigational Site

Halle, 06120, Germany

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GSK Investigational Site

Heidelberg, 69126, Germany

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GSK Investigational Site

Karlsruhe, 76137, Germany

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GSK Investigational Site

München, 80336, Germany

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GSK Investigational Site

München, 81925, Germany

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GSK Investigational Site

Oldenburg, 26121, Germany

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GSK Investigational Site

Athens, 115 27, Greece

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GSK Investigational Site

Athens, 11526, Greece

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GSK Investigational Site

Athens, 11528, Greece

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GSK Investigational Site

Athens, 12462, Greece

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GSK Investigational Site

Larissa, 41100, Greece

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GSK Investigational Site

Pylaia Thessaloniki, 570 01, Greece

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GSK Investigational Site

Rio Patras, 26504, Greece

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GSK Investigational Site

Thessaloniki, 55236, Greece

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GSK Investigational Site

Thessaloniki, 57010, Greece

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GSK Investigational Site

Ancona, 60126, Italy

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GSK Investigational Site

Avellino, 83100, Italy

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GSK Investigational Site

Florence, 50134, Italy

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GSK Investigational Site

Milan, 20132, Italy

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GSK Investigational Site

Milan, 20133, Italy

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GSK Investigational Site

Monza, 20900, Italy

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GSK Investigational Site

Napoli, 80131, Italy

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GSK Investigational Site

Orbassano to, 10043, Italy

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GSK Investigational Site

Perugia, 06156, Italy

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GSK Investigational Site

Siena, 53100, Italy

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GSK Investigational Site

Kyoto, 612-8555, Japan

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GSK Investigational Site

Miyagi, 981-1293, Japan

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GSK Investigational Site

Osaka, 591-8555, Japan

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GSK Investigational Site

Yamaguchi, 755-0241, Japan

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GSK Investigational Site

Guadalajara, 44280, Mexico

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GSK Investigational Site

Mexico City, 03100, Mexico

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GSK Investigational Site

Mexico City, 03810, Mexico

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GSK Investigational Site

Mexico City, 06700, Mexico

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GSK Investigational Site

Mexico City, CP 14080, Mexico

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GSK Investigational Site

Monterrey, 64460, Mexico

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GSK Investigational Site

Puebla Puebla, 72560, Mexico

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GSK Investigational Site

Amersfoort, 3813 TZ, Netherlands

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GSK Investigational Site

Enschede, 7512 KZ, Netherlands

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GSK Investigational Site

Groningen, 9713 GZ, Netherlands

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GSK Investigational Site

Harderwijk, 3844 DG, Netherlands

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GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

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GSK Investigational Site

Utrecht, 3543 AZ, Netherlands

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GSK Investigational Site

Zwolle, 8025 AB, Netherlands

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GSK Investigational Site

Bydgoszcz, 85-796, Poland

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GSK Investigational Site

Gdynia, 81-519, Poland

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GSK Investigational Site

Lodz, 90-338, Poland

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GSK Investigational Site

Olsztyn, 10-357, Poland

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GSK Investigational Site

Piła, 64-920, Poland

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GSK Investigational Site

Poznan, 60-693, Poland

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GSK Investigational Site

Bucharest, 013812, Romania

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GSK Investigational Site

Craiova, 200347, Romania

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GSK Investigational Site

Craiova Dolj, 200385, Romania

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GSK Investigational Site

Otopeni, 075100, Romania

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GSK Investigational Site

Timișoara, 300239, Romania

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GSK Investigational Site

Chelyabinsk, 454048, Russia

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GSK Investigational Site

Moscow Region, 143423, Russia

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GSK Investigational Site

Pushkin, 196603, Russia

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GSK Investigational Site

Saint Petersburg, 197022, Russia

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GSK Investigational Site

Cheongju Chungcheongbuk-do, 28644, South Korea

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GSK Investigational Site

Daegu, 42601, South Korea

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GSK Investigational Site

Gyeonggi-do, 10408, South Korea

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GSK Investigational Site

Pusan, 49241, South Korea

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GSK Investigational Site

Seongnam-si Gyeonggi-do, 13620, South Korea

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GSK Investigational Site

Seoul, 03722, South Korea

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GSK Investigational Site

Seoul, 05505, South Korea

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GSK Investigational Site

Seoul, 06351, South Korea

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GSK Investigational Site

Seoul, 08308, South Korea

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GSK Investigational Site

Suwon Kyunggi-do, 443-721, South Korea

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GSK Investigational Site

A Coruña, 15006, Spain

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Burgos, 09006, Spain

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GSK Investigational Site

Córdoba, 140044, Spain

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GSK Investigational Site

Las Palmas de Gran Canar, 35016, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Madrid, 28050, Spain

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GSK Investigational Site

Madrid, 28222, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Valencia, 46026, Spain

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GSK Investigational Site

Gävle, SE-801 87, Sweden

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GSK Investigational Site

Stockholm, 171 64, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Taipei, 11217, Taiwan

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GSK Investigational Site

Dusit, 10300, Thailand

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GSK Investigational Site

Kho Hong Hat Yai, 90110, Thailand

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GSK Investigational Site

Khon Kaen, 40002, Thailand

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GSK Investigational Site

Pathum Thani, 12120, Thailand

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GSK Investigational Site

Adana, 1120, Turkey (Türkiye)

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GSK Investigational Site

Antalya, 07020, Turkey (Türkiye)

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GSK Investigational Site

Izmir, 35600, Turkey (Türkiye)

Location

GSK Investigational Site

Cardiff, CF14 2TL, United Kingdom

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GSK Investigational Site

Edinburgh, EH4 2XU, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

GSK Investigational Site

London, W1G 6AD, United Kingdom

Location

GSK Investigational Site

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dostarlimab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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: November 30, 2020
• First Posted: December 7, 2020
• Study Start: December 8, 2020
• Primary Completion: June 5, 2025
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

AU (6); TU (3); BE (3); FI (2); GR (9); US (17); IT (10); ES (15); TW (1); RO (5); KR (10); SE (3); DE (15); TH (4); GB (5); PL (6); CA (5); BR (7); ME (7); FR (7); RU (4); NL (7); AR (8); JP (4)