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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT02087423

Run by

AstraZeneca

People needed

446

Starts

2014-02-25

Expected to finish

2025-03-26

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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))

You may not qualify if…

• 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)

Where it is running

• Research Site — Santa Rosa, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Port Saint Lucie, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Waterloo, Iowa, United States
• Research Site — Topeka, Kansas, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Burlington, Massachusetts, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Saint Louis Park, Minnesota, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Huntersville, North Carolina, United States
• Research Site — Bismarck, North Dakota, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Blue Ash, Ohio, United States
• Research Site — Canton, Ohio, United States
• Research Site — Middletown, Ohio, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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