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

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 Non-small 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

• 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 serious adverse events (SAEs)
• Number of participants with treatment-emergent adverse events (TEAEs) 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 clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters
• Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status
• Number of participants with usage of concomitant medications
• Number of participants with abnormal physical examinations

View this trial on ClinicalTrials.gov