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

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