AzTrials
AzTrials

Lung Cancer, Non-Small CellPhase 2/3COSTAR LungNCT04655976

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 Phase 2/3 study testing Cobolimab, Dostarlimab and Docetaxel in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 163 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
Cobolimab, Dostarlimab and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
758 participants
Where
163 sitesin 24 countries
Study dates
8 Dec 2020to 30 Mar 2027
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

163 sites in 24 countries.

163 sites in 24 countries

United States17 sites

  • GSK Investigational Site

    Edgewood, Kentucky, 41017

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Fredericksburg, Virginia, 22408

  • GSK Investigational Site

    Honolulu, Hawaii, 96819

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Las Vegas, Nevada, 89144

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Walnut Creek, California, 94596

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20422

  • GSK Investigational Site

    White Plains, New York, 10601

Other trials in United States

Germany15 sites

  • GSK Investigational Site

    Augsburg, 86156

  • GSK Investigational Site

    Bad Berka, 99437

  • GSK Investigational Site

    Berlin, 12200

  • GSK Investigational Site

    Bonn, 53113

  • GSK Investigational Site

    Cologne, 51109

  • GSK Investigational Site

    Dresden, 01307

  • GSK Investigational Site

    Essen, 45147

  • GSK Investigational Site

    Frankfurt, 60488

  • GSK Investigational Site

    Frankfurt, 60590

  • GSK Investigational Site

    Halle, 06120

  • GSK Investigational Site

    Heidelberg, 69126

  • GSK Investigational Site

    Karlsruhe, 76137

  • GSK Investigational Site

    München, 80336

  • GSK Investigational Site

    München, 81925

  • GSK Investigational Site

    Oldenburg, 26121

Other trials in Germany

Spain15 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Córdoba, 140044

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Madrid, 28222

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Valencia, 46026

Other trials in Spain

Italy10 sites

  • GSK Investigational Site

    Ancona, 60126

  • GSK Investigational Site

    Avellino, 83100

  • GSK Investigational Site

    Florence, 50134

  • GSK Investigational Site

    Milan, 20132

  • GSK Investigational Site

    Milan, 20133

  • GSK Investigational Site

    Monza, 20900

  • GSK Investigational Site

    Naples, 80131

  • GSK Investigational Site

    Orbassano to, 10043

  • GSK Investigational Site

    Perugia, 06156

  • GSK Investigational Site

    Siena, 53100

Other trials in Italy

South Korea10 sites

  • GSK Investigational Site

    Cheongju Chungcheongbuk-do, 28644

  • GSK Investigational Site

    Daegu, 42601

  • GSK Investigational Site

    Gyeonggi-do, 10408

  • GSK Investigational Site

    Pusan, 49241

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 06351

  • GSK Investigational Site

    Seoul, 08308

  • GSK Investigational Site

    Suwon Kyunggi-do, 443-721

Other trials in South Korea

Greece9 sites

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 11526

  • GSK Investigational Site

    Athens, 11528

  • GSK Investigational Site

    Athens, 12462

  • GSK Investigational Site

    Larissa, 41100

  • GSK Investigational Site

    Pylaia Thessaloniki, 570 01

  • GSK Investigational Site

    Rio Patras, 26504

  • GSK Investigational Site

    Thessaloniki, 55236

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1425

  • GSK Investigational Site

    Florida, 1602

  • GSK Investigational Site

    La Rioja, F5300COE

  • GSK Investigational Site

    Pergamino, B2700CPM

  • GSK Investigational Site

    Rosario, S2000DBS

  • GSK Investigational Site

    Viedma, R8500ACE

Other trials in Argentina

Brazil7 sites

  • GSK Investigational Site

    Blumenau, 89010340

  • GSK Investigational Site

    Fortaleza, 60336-232

  • GSK Investigational Site

    Porto Alegre, 90610000

  • GSK Investigational Site

    Rio de Janeiro, 22061080

  • GSK Investigational Site

    Rio de Janeiro, 22250-905

  • GSK Investigational Site

    Salvador, 40170-110

  • GSK Investigational Site

    São Paulo, 04014-002

Other trials in Brazil

France7 sites

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Marseille, 13009

  • GSK Investigational Site

    Nice, 06189

  • GSK Investigational Site

    Quimper, 29107

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Tours, 37044

Other trials in France

Mexico7 sites

  • GSK Investigational Site

    Guadajalara, 44280

  • GSK Investigational Site

    Mexico City, 03100

  • GSK Investigational Site

    Mexico City, 03810

  • GSK Investigational Site

    Mexico City, 06700

  • GSK Investigational Site

    Mexico City, CP 14080

  • GSK Investigational Site

    Monterrey, 64460

  • GSK Investigational Site

    Puebla Puebla, 72560

Other trials in Mexico

Netherlands7 sites

  • GSK Investigational Site

    Amersfoort, 3813 TZ

  • GSK Investigational Site

    Enschede, 7512 KZ

  • GSK Investigational Site

    Groningen, 9713 GZ

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Utrecht, 3543 AZ

  • GSK Investigational Site

    Zwolle, 8025 AB

Other trials in Netherlands

Australia6 sites

  • GSK Investigational Site

    Ashford, South Australia, 5037

  • GSK Investigational Site

    Ballarat, Victoria, 3350

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Mount Waverley, Victoria, 3350

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

Other trials in Australia

Poland6 sites

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Gdynia, 81-519

  • GSK Investigational Site

    Lodz, 90-338

  • GSK Investigational Site

    Olsztyn, 10-357

  • GSK Investigational Site

    Piła, 64-920

  • GSK Investigational Site

    Poznan, 60-693

Other trials in Poland

Canada5 sites

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 5J1

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9

Other trials in Canada

Romania5 sites

  • GSK Investigational Site

    Bucharest, 013812

  • GSK Investigational Site

    Craiova, 200347

  • GSK Investigational Site

    Craiova Dolj, 200385

  • GSK Investigational Site

    Otopeni, 075100

  • GSK Investigational Site

    Timișoara, 300239

Other trials in Romania

United Kingdom5 sites

  • GSK Investigational Site

    Cardiff, CF14 2TL

  • GSK Investigational Site

    Edinburgh, EH4 2XU

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, W1G 6AD

  • GSK Investigational Site

    Manchester, M20 4BX

Other trials in United Kingdom

Japan4 sites

  • GSK Investigational Site

    Kyoto, 612-8555

  • GSK Investigational Site

    Miyagi, 981-1293

  • GSK Investigational Site

    Osaka, 591-8555

  • GSK Investigational Site

    Yamaguchi, 755-0241

Other trials in Japan

Russia4 sites

  • GSK Investigational Site

    Chelyabinsk, 454048

  • GSK Investigational Site

    Moscow Region, 143423

  • GSK Investigational Site

    Pushkin, 196603

  • GSK Investigational Site

    Saint Petersburg, 197022

Other trials in Russia

Thailand4 sites

  • GSK Investigational Site

    Dusit, 10300

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Pathum Thani, 12120

Other trials in Thailand

Belgium3 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Kortrijk, 8500

Other trials in Belgium

Sweden3 sites

  • GSK Investigational Site

    Gävle, SE-801 87

  • GSK Investigational Site

    Stockholm, 171 64

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Turkey (Türkiye)3 sites

  • GSK Investigational Site

    Adana, 1120

  • GSK Investigational Site

    Antalya, 07020

  • GSK Investigational Site

    Izmir, 35600

Other trials in Turkey (Türkiye)

Finland2 sites

  • GSK Investigational Site

    Helsinki, 00180

  • GSK Investigational Site

    Kuopio, 70210

Other trials in Finland

Taiwan1 site

  • GSK Investigational Site

    Taipei, 11217

Other trials in Taiwan

About this study

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)

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.

Being tested
Cobolimab, Dostarlimab, Docetaxel
Keywords
GSK4069889A, GSK4057190A, Cobolimab, Dostarlimab, Docetaxel, Chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobolimabBiological

    Cobolimab will be administered.

  • DostarlimabBiological

    Dostarlimab will be administered.

  • DocetaxelDrug

    Docetaxel will be administered.

Study groups in NCT04655976
Study groupRoleWhat they receive
Participants receiving cobolimab+ dostarlimab+ docetaxelExperimentalNot described
Receives: Biological: Cobolimab; Biological: Dostarlimab; Drug: Docetaxel
Participants receiving dostarlimab+ docetaxelExperimentalNot described
Receives: Biological: Dostarlimab; Drug: Docetaxel
Participants receiving docetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) (Arm A Versus Arm C)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 234 weeks

  2. Overall Survival (OS) (Arm B Versus Arm C)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 234 weeks

Secondary outcomes (19)

  1. Overall Survival (OS) (Arm A Versus Arm B)

    OS is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Up to approximately 234 weeks

  2. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR) as the best overall response based on Investigator assessment, evaluated using Response Evaluation Criteria in Solid Tumors Criteria (RECIST) version 1.1 . PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm).

    Measured: Up to approximately 234 weeks

  3. Progression Free Survival (PFS)

    PFS is defined as the length of time from randomization to the earliest date of assessment of disease progression based on RECIST v1.1 by Investigator assessment or death by any cause, whichever occurs first. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start. In addition, the sum has an absolute increase from nadir of 5 mm.)

    Measured: Up to approximately 234 weeks

  4. Duration of Response (DOR)

    DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first. PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).

    Measured: Up to approximately 234 weeks

  5. Time to Deterioration (TTD) in Lung Cancer

    TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC-QLQ-LC13).

    Measured: Up to approximately 234 weeks

  6. Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score

    The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline [Day(D) -1],D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

  7. Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13 Item Lung Cancer Module (EORTC-QLQ-LC13) Assessment

    The QLQ-LC13 questionnaire comprises 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea and site-specific pain which includes pain in chest, pain in arm or shoulder and pain in other parts), and treatment-related side effects (sore mouth [SM], dysphagia, peripheral neuropathy [PN] and alopecia). Response options are 1 (Not at all) to 4 (Very much). Scores were averaged and transformed to 0 to 100. Higher scores represent increasing symptom levels. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (D -1),D1 on Cycle(C)(s) 2,3,4,5,6,9,12,15,18,22,26,30,34,38,42,46,50,54, 58,62,66, End of treatment (EoT- up to approximately(~) 216 weeks), Safety follow up (SFU) at D30 after EOT (~ 220 weeks) & at D90 after EOT (~ 229 weeks)

  8. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

    ECGs were recorded after the participants were in a supine or semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes. ECG findings are summarized as clinically significant change from baseline worst case hierarchy: Yes > No > Not Applicable (NA).

    Measured: Baseline (Day-1) up to Cycle 1 Day 1

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Immune-mediate AEs (imAEs)

    A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

    Measured: Up to 329 weeks

  10. Number of Participants With TEAEs Leading to Death and Treatment Discontinuation

    A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

    Measured: Up to 329 weeks

  11. Number of Participants Using Concomitant Medications

    Number of participants using concomitant medications will be presented.

    Measured: Up to 329 weeks

  12. Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of hematology parameters.

    Measured: Up to 329 weeks

  13. Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of Clinical Chemistry parameters.

    Measured: Up to 329 weeks

  14. Number of Participants With Worst Case Thyroid Function Results by Maximum Grade Increase Post-Baseline Relative to Baseline

    Blood samples will be collected for the analysis of thyroid function

    Measured: Up to 329 weeks

  15. Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline

    Urine samples will be collected to analyze urine specific gravity.

    Measured: Up to 329 weeks

  16. Number of Participants With Worst Case Vital Signs Results Relative to Normal Range Post-Baseline Relative to Baseline

    Vital signs will be assessed

    Measured: Up to 329 weeks

  17. Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Vital Signs

    Vital signs will be assessed and presented

    Measured: Baseline (Day -1) and Up to 281 weeks

  18. Number of Participants With Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status

    Performance status will be assessed using the ECOG performance status scale.

    Measured: Up to 329 weeks

  19. Number of Participants With Abnormal Physical Examinations

    Number of participants with abnormal physical examinations will be presented

    Measured: Up to approximately 234 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start8 Dec 2020
  3. Primary completion5 Jun 2025
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04655976
Sponsor's protocol ID
213410
Other IDs
2020-003433-37
Acronym
COSTAR Lung
Status last verified
Jun 2026
First submitted
30 Nov 2020
Last updated
1 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cobolimab, Dostarlimab and Docetaxel in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 163 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States, Germany, Spain, Italy, South Korea and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (Arm A Versus Arm C) (time frame: Up to approximately 234 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04655976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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