A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Completed · Phase 3

Conditions studied: Non - Small Cell Lung Cancer NSCLC

In brief

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)

Key facts

Study ID

NCT02352948

Run by

AstraZeneca

People needed

597

Starts

2015-01-13

Expected to finish

2023-08-30

Last updated by the study team

2024-07-26

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 regimen and at least 1 additional regimen for treatment of NSCLC
• World Health Organization (WHO) Performance Status of 0 or 1
• Estimated life expectancy more than 12 weeks

You may not qualify if…

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
• Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
• Active or prior documented autoimmune disease within the past 2 years
• Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
• Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy
• Known EGFR TK activating mutations or ALK rearrangements
• 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 — Anaheim, California, United States
• Research Site — Duarte, California, United States
• Research Site — La Jolla, California, United States
• Research Site — San Diego, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Port Saint Lucie, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Waterloo, Iowa, United States
• Research Site — Ashland, Kentucky, United States
• Research Site — Rockville, Maryland, United States
• Research Site — Battle Creek, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Mineola, 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 — Charlotte, North Carolina, United States
• Research Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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