Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

Official Title

A Phase III, Randomized, Multicentre, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)

Summary:

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicentre study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

Trial Description

Primary Outcome:

  • Disease free survival (DFS) in MRD+ analysis set (using Investigator assessments according to RECIST 1.1)
Secondary Outcome:
  • DFS in FAS (using Investigator assessments according to RECIST 1.1)
  • DFS (using BICR assessments according to RECIST 1.1) in MRD+ analysis set and in FAS
  • OS in MRD+ analysis set and in FAS
  • Change from baseline in EORTC QLQ-LC13 score
  • Time to deterioration in EORTC QLQ-LC13 score
  • Change from baseline in EORTC QLQ-C30 score
  • Time to deterioration in EORTC QLQ-C30 score
Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm. The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy compared to placebo+ SoC chemotherapy in terms of DFS measured in MRD+ patients.

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