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- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (COSTAR Lung)
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|ClinicalTrials.gov Identifier: NCT04655976|
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : November 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Non-Small Cell||Biological: Cobolimab Biological: Dostarlimab Drug: Docetaxel||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will receive treatment in a 2:2:1 randomisation; cobolimab + dostarlimab + docetaxel; dostarlimab + docetaxel; docetaxel.|
|Masking:||None (Open Label)|
|Masking Description:||This is an open label (unblinded) 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 Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)|
|Actual Study Start Date :||December 8, 2020|
|Estimated Primary Completion Date :||September 6, 2024|
|Estimated Study Completion Date :||January 1, 2026|
|Experimental: Participants receiving cobolimab+dostarlimab+docetaxel||
Cobolimab will be administered
Dostarlimab will be administered
Docetaxel will be administered
|Experimental: Participants receiving dostarlimab+docetaxel||
Dostarlimab will be administered
Docetaxel will be administered
|Active Comparator: Participants receiving docetaxel||
Docetaxel will be administered
- Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone [ Time Frame: Up to 44 months ]OS is defined as survival from the date of randomization to the date of death by any cause
- OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone [ Time Frame: Up to 44 months ]OS is defined as survival from the date of randomization to the date of death by any cause
- OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel [ Time Frame: Up to 44 months ]OS is defined as survival from the date of randomization to the date of death by any cause
- Objective response rate (ORR) [ Time Frame: Up to 44 months ]Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment
- Progression free survival (PFS) [ Time Frame: Up to 44 months ]PFS is defined as the length of time until disease progression, from the time of randomization to the earliest date of assessment of disease progression based on RECIST version 1.1 by Investigator assessment or death by any cause
- Duration of response (DOR) [ Time Frame: Up to 44 months ]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
- Time to deterioration (TTD) [ Time Frame: Up to 44 months ]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)
- Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment [ Time Frame: Baseline (Day 1) and up to 44 months ]EORTC QLQ-C30 is a questionnaire used to measure health related quality of life (HRQoL) in participants with cancer.
- Change from Baseline in the EORTC QLQ LC13 assessment [ Time Frame: Baseline (Day 1) and up to 44 months ]EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30.
- Number of participants with serious adverse events (SAEs) [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
- Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs) [ Time Frame: From consent signature (Day -28) until the 30 day post last dose follow-up ]
- Number of participants with TEAEs leading to death [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
- Number of participants with adverse events (AEs) leading to discontinuation [ Time Frame: From consent signature (Day -28) until the 30 day post last dose follow-up ]
- Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]Blood and urine samples will be collected for the assessment of hematology, clinical chemistry, thyroid function and urinalysis lab parameters
- Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
- Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]Performance status will be assessed using the ECOG performance status scale. Scales range from grade 0 to 4, grade 0 denoting fully active and grade 4 completely disabled.
- Number of participants with usage of concomitant medications [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
- Number of participants with abnormal physical examinations [ Time Frame: From consent signature (Day -28) until the 90 day post last dose follow-up ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655976
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center||+44 (0) 20 89904466||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|
|Other Study ID Numbers:||
2020-003433-37 ( EudraCT Number )
|First Posted:||December 7, 2020 Key Record Dates|
|Last Update Posted:||November 18, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||IPD for this study will be made available via the Clinical Study Data Request site.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action