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)

• Status: Recruiting
• Trial end date: 2026-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab

Criteria

Inclusion Criteria:

1. 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

2. Age ≥18 years at the time of screening

3. Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease

4. Complete resection of the primary NSCLC

Exclusion Criteria:

1. Postoperative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence

2. EGFR-mutant and/or ALK-translocation

3. Mixed small cell and NSCLC histology

4. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab