Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

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)

Details

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)

Keywords

Non-Small Cell Lung Cancer Locally advanced Unresectable Non-Small Cell Lung Cancer MEDI4736 PD-L1 Stage III Non-Small Cell Lung Cancer Chemoradiation Immune-mediated cancer therapy Lung Neoplasms Carcinoma, Non-Small-Cell Lung Durvalumab

Eligibility

You can join if…

Open to people ages 18-130

  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.

You CAN'T join if...

  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

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
Related Info revised CSP
ID
NCT02125461
Phase
Phase 3
Study Type
Interventional
Last Updated