A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

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

Summary

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Aged at least 18 years.

• Documented evidence of NSCLC (stage IIIB/IV disease)

• Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC

• World Health Organisation (WHO) Performance Status of 0 or 1

• Estimated life expectancy of more than 12 weeks

• Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

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

• Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).

• Active or prior autoimmune disease or history of immunodeficiency

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

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

• Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.

• Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1

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