Summary

for people ages 18-130 (full criteria)
at UCLA
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 Antibodies, Monoclonal

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
    La Mesa California 91942 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com 1-877-400-465
ID
NCT02125461
Phase
Phase 3
Study Type
Interventional
Last Updated