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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

Trial Status: Closed to Accrual

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

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
New York
Icahn School of Medicine at Mount Sinai
Status: COMPLETED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Texas

Houston
M D Anderson Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Singapore

Singapore
Johns Hopkins Singapore
Status: CLOSED_TO_ACCRUAL
Contact: Akhil Chopra
Phone: 65-68802171

A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC)

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D4191C00001
  • Secondary IDs NCI-2014-02246
  • Clinicaltrials.gov ID NCT02125461