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

NCT02125461

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: MEDI4736, PLACEBO

Countries: United States, Australia, Belgium, Canada, Chile, France, Germany, Greece

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).
Locations (236)
  • Chandler, Arizona, United States
  • Goodyear, Arizona, United States
  • Jonesboro, Arkansas, United States
  • Springdale, Arkansas, United States
  • Fullerton, California, United States
  • Los Angeles, California, United States
  • Oxnard, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Santa Rosa, California, United States
  • Norwich, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Miami Beach, Florida, United States
  • Orlando, Florida, United States
  • Port Saint Lucie, Florida, United States
  • St. Petersburg, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Fort Gordon, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Marietta, Georgia, United States
  • Waterloo, Iowa, United States
  • Topeka, Kansas, United States
  • Hazard, Kentucky, United States
  • Baltimore, Maryland, United States
  • Rockville, Maryland, United States
  • Rosedale, Maryland, United States
  • + 206 more on CT.gov