A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A Global Study to Assess the Effects of MEDI4736 following concurrent chemoradiation in Patients with Stage III Unresectable Non-Small Cell Lung Cancer.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab

Criteria

Inclusion Criteria:

1. Age at least 18 years.

2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III)

3. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.

4. World Health Organisation (WHO) Performance Status of 0 to 1.

5. Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

1. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.

2. Active or prior autoimmune disease or history of immunodeficiency.

3. Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.

4. Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.

5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.

6. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).