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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.

Description

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.

Phase

N/A

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

Sites

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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