Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

Official Title

A Phase 2 Open-label, Multicentre, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

Summary:

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Trial Description

Primary Outcome:

  • Objective Response (OR) rate as a measure of antitumour activity of durvalumab alone vs durvalumab in combination with novel agents
Secondary Outcome:
  • Incidence of Adverse Events as a measure of safety during the treatment period
  • Duration of Response (DoR) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
  • Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
  • Progression-Free Survival (PFS) and Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
  • Serum durvalumab concentration levels
  • Serum concentration levels of durvalumab or novel agents
  • Development of detectable anti-drug antibody (ADA) to durvalumab
  • Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents
  • Number of patients with clinically significant laboratory values as a measure of safety
  • Incidence of clinically significant vital sign values as a measure of safety
Study D9108C00001 (COAST) is a Phase 2, open-label, multicentre, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).

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