Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

Official Title

A Phase III, Randomized, Multicentre, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

Summary:

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

Trial Description

Primary Outcome:

  • DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1)
Secondary Outcome:
  • DFS in FAS (using Investigator assessments according to RECIST 1.1)
  • PFS (using local standard practice)
  • Time to first subsequent therapy (TFST)
  • Time to second subsequent therapy (TSST)
  • Change from baseline in EORTC QLQ-C30
  • Change from baseline in EORTC QLQ-LC13
  • Time to deterioration in EORTC QLQ-C30
  • Time to deterioration in EORTC QLQ-LC13
  • IHC analysis of PD-L1 TC expression and spatial distribution within the tumour microenvironment relative to efficacy outcomes (ie, DFS, OS)The Ventana SP263 PD-L1 immunohistochemistry (IHC) assay will be used to determine PDL1 status in all specimens.
  • DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC≥1% analysis set
  • DFS (using BICR assessments according to RECIST 1.1) in FAS
  • OS in PD-L1 TC≥1% analysis set
  • OS in FAS
This is a Phase III, randomized, multicentre, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during a 96-week surveillance period.

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