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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT02125461

Run by

AstraZeneca

People needed

713

Starts

2014-05-07

Expected to finish

2023-08-24

Last updated by the study team

2023-10-10

Who can join

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

You may qualify if…

• Age at least 18 years.
• Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
• Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
• World Health Organisation (WHO) Performance Status of 0 to 1.
• Estimated life expectancy of more than 12 weeks.

You may not qualify if…

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
• 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 the prior chemoradiation therapy.
• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

Where it is running

• Research Site — Goodyear, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Springdale, Arkansas, United States
• Research Site — Fullerton, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Oxnard, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami Beach, 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 — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Fort Gordon, Georgia, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Marietta, Georgia, United States
• Research Site — Waterloo, Iowa, United States
• Research Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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