A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
- 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.
- 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).
District of Columbia
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
AstraZeneca Pharmaceuticals LP
- Primary ID D4191C00001
- Secondary IDs NCI-2014-02246
- Clinicaltrials.gov ID NCT02125461