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A Phase III, Randomized, Multicenter, 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.


Brief 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.

Detailed Description
This is a Phase III, randomized, multicenter, 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 Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during a 96-week surveillance period.



Inclusion and Exclusion Criteria

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.
  • Age ≥18 years at the time of screening (ICF1);
  • Histologically confirmed NSCLC with resectable stage II-III disease
  • Complete resection of the primary NSCLC

  • EGFR and/or ALK mutant
  • Mixed small cell and NSCLC histology
  • History of allogeneic organ or bone marrow transplantation
  • History of active primary immunodeficiency


Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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