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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)

Trial Status: Active

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter 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

Inclusion Criteria

  • Capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and study protocol
  • Age ≥18 years at the time of screening
  • Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
  • Complete resection of the primary NSCLC

Exclusion Criteria

  • Postoperative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence
  • EGFR-mutant and/or ALK-translocation
  • Mixed small cell and NSCLC histology
  • Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: APPROVED

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Texas

San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: IN_REVIEW
Contact: Sonia Lisa Creighton
Phone: 210-450-1366

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D910LC00001
  • Secondary IDs NCI-2020-13739
  • Clinicaltrials.gov ID NCT04385368