Study of Cobolimab in Combination With Dostarlimab and Docetaxel in Advanced NSCLC Participants

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)

Summary:

This is a multi-centre, parallel group treatment, Phase 2 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Nonsmall cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Trial Description

Primary Outcome:

  • Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
  • OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
Secondary Outcome:
  • OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel
  • Objective response rate (ORR)
  • Progression free survival (PFS)
  • Duration of response (DOR)
  • Time to deterioration (TTD)
  • 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
  • Change from Baseline in the EORTC QLQ LC13 assessment
  • Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and immune related adverse event (irAEs)
  • Number of participants with TEAEs leading to death
  • Number of participants with adverse events (AEs) leading to discontinuation
  • Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters
  • Number of participants with abnormal findings in vital signs
  • Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status
  • Number of participants with abnormal findings in Electrocardiogram (ECG) Parameters
  • Number of participants with usage of concomitant medications
  • Number of participants with abnormal physical examinations

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society