A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/30/2019
Start Date:October 25, 2013
End Date:April 24, 2019

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A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in
combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in
combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK),
immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult
subjects with advanced NSCLC.

Inclusion Criteria:

1. Age ≥ 18 years

2. Advanced non-small cell lung cancer

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

4. Adequate organ and marrow function

Exclusion Criteria:

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer
treatment

2. Current or prior use of immunosuppressive medication within 14 days before the first
dose of study drugs

3. Active or prior documented autoimmune disease within the last 2 years.
We found this trial at
26
sites
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Columbus, OH
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Ann Arbor, MI
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Aurora, CO
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Baltimore, MD
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Birmingham, AL
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Boston, MA
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Darlinghurst,
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Detroit, MI
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Fairfax, VA
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Fort Worth, TX
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1357
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Houston, TX
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Huntersville, North Carolina 28078
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Huntersville, NC
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Indianapolis, IN
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Lebanon, NH
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Los Angeles, CA
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Morgantown, WV
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New Haven, CT
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New York, NY
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Newark, DE
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Portland, OR
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Saint Louis, MO
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355
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San Francisco, CA
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Seattle, WA
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Tampa, FL
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Tucson, AZ
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1315
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Tyler, TX
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