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



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:4/4/2019
Start Date:May 7, 2014
End Date:July 9, 2019

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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)

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

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)

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).
We found this trial at
60
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Burlington, North Carolina 27215
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Burlington, NC
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Atlanta, GA
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Austin, TX
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Bedford Park,
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Boston, MA
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Bronx, NY
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Chandler, AZ
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Charlotte, North Carolina 28207
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Charlotte, NC
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chattanooga, TN
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Cincinnati, OH
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Dallas, TX
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Easley, SC
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Fairfax, VA
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Fayetteville, AR
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Fort Myers, FL
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Fullerton, CA
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Goodyear, AZ
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Hackensack, NJ
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Hazard, KY
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Houston, TX
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Lake Success, NY
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Los Angeles, CA
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Miami Beach, FL
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Orlando, FL
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Oxnard, CA
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Pinehurst, North Carolina 28374
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Port Saint Lucie, FL
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Saint Petersburg, Florida 33713
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Vancouver, WA
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Washington,
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Waterloo, IA
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Winston-Salem, NC
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