Last updated: 09/25/2025 11:40:59

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 ChemotherapyCOSTAR Lung

GSK study ID
213410
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to approximately 52 months

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

Timeframe: Up to approximately 52 months

Secondary outcomes:

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

Timeframe: Up to approximately 52 months

Objective response rate (ORR)

Timeframe: Up to approximately 52 months

Progression free survival (PFS)

Timeframe: Up to approximately 52 months

Duration of response (DOR)

Timeframe: Up to approximately 52 months

Time to deterioration (TTD)

Timeframe: Up to approximately 52 months

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

Timeframe: Baseline (Day 1) and up to approximately 52 months

Change from Baseline in the EORTC QLQ LC13 assessment

Timeframe: Baseline (Day 1) and up to approximately 52 months

Number of participants with serious adverse events (SAEs)

Timeframe: 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)

Timeframe: From consent signature (Day -28) until the 30 day post last dose follow-up

Number of participants with TEAEs leading to death

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with adverse events (AEs) leading to discontinuation

Timeframe: 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

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters

Timeframe: 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

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with usage of concomitant medications

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Number of participants with abnormal physical examinations

Timeframe: From consent signature (Day -28) until the 90 day post last dose follow-up

Interventions:
  • Biological/vaccine: Cobolimab
  • Biological/vaccine: Dostarlimab
  • Drug: Docetaxel
  • Enrollment:
    758
    Primary completion date:
    2025-05-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Lung Cancer, Non-Small Cell
    Product
    Not applicable
    Collaborators
    NA
    Study date(s)
    December 2020 to March 2027
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    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 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 05505
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seongnam-si Gyeonggi-do, South Korea, 13620
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Orbassano TO, Italy, 10043
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Ashford, SA, Australia, 5037
    Status
    Study Complete
    Location
    GSK Investigational Site
    Olsztyn, Poland, 10-357
    Status
    Recruitment Complete
    Location
    GSK Investigational Site
    Bydgoszcz, Poland, 85-796
    Status
    Recruitment Complete
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    2025-05-06
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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