Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Official Title

A Phase 2 Open-label, Multicentre, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

Summary:

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

Trial Description

Primary Outcome:

  • Major Pathological Response rate
Secondary Outcome:
  • Feasibility to surgery within the 14 days window period is a dichotomic variable: patients will have or will not have the tumour surgical resection done.
  • AEs and SAEs
  • Pathological Complete Response rate
  • Concentration of durvalumab or novel agents in plasma or serum.
  • ADA incidence of durvalumab or novel biologic agents.

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