Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

• Status: Recruiting
• Trial end date: 2027-10-29
• Target enrollment: 0
• Participant gender: All

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.

• 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 compliance with the requirements and restrictions listed in the ICFs and in the protocol.

2. Age ≥18 years at the time of screening (ICF1);

3. Histologically confirmed NSCLC with resectable stage II-III disease

4. Complete resection of the primary NSCLC

Exclusion Criteria:

1. EGFR and/or ALK mutant

2. Mixed small cell and NSCLC histology

3. History of allogeneic organ or bone marrow transplantation

4. History of active primary immunodeficiency