NCT04655976Active, not recruitingPhase 2/3
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
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)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 758 (actual)
- First submitted
- 30 Nov 2020
- Start date
- 8 Dec 2020
- Primary completion date
- 5 Jun 2025
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lung cancer
- NCT number
- NCT04655976
- EU CT number
- 2023-507475-21-00
- EudraCT number
- 2020-003433-37
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 758
- From 8 Dec 2020 to the primary completion date, 5 Jun 2025
- 137 sites in 24 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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 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 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).
Other illness
- Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
- 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.
Lab values
- 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 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (137)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cipoletti Rio Negro | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Florida | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | La Rioja | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pergamino | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ashford | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ballarat | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mount Waverley | Australia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Onze-Lieve-Vrouwziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Completed |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Completed |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Greenfield Park | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Pohjois-Savon hyvinvointialue Coordinator of this site? Confirm its status | Kuopio | Finland | Completed |
| Centre Hospitalier Intercommunal Creteil Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Completed |
| AORN San Giuseppe Moscati Avellino Coordinator of this site? Confirm its status | Avellino | Italy | Completed |
| Careggi University Hospital Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Completed |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Completed |
| Azienda Ospedaliera Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Yamaguchi | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cheongju Chungcheongbuk-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seongnam-si Gyeonggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Suwon Kyunggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Guadajalara | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Puebla Puebla | Mexico | Unknown status |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Active, not recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| Ziekenhuis St Jansdal Coordinator of this site? Confirm its status | Harderwijk | Netherlands | Active, not recruiting |
| Stichting Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Ars Medical Sp. z o.o. Coordinator of this site? Confirm its status | Pila | Poland | Active, not recruiting |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Memorial Healthcare International S R L Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Oncolab S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Radiology Therapeutic Center S.R.L. Coordinator of this site? Confirm its status | Otopeni | Romania | Active, not recruiting |
| Oncomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Moscow Region | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pushkin | Russia | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Completed |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Dusit | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kho Hong Hat Yai | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fredericksburg | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Norwich | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | White Plains | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.