NCT02000947

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 459 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• NSCLC
• Non-small Cell Lung Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	MEDI4736	MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
DRUG	Tremelimumab	Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
DRUG	tremelimumab	Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).

Timeline

• Start date: 2013-10-25
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2013-12-04
• Last updated: 2019-10-31

Locations

69 sites across 9 countries: United States, Australia, Belgium, France, Italy, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study