Spots Global Cancer Trial Database for A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
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Trial Identification
Brief Title: A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
Official Title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Lung Cancer
Study ID: NCT03846310
Study Description
Brief Summary: This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).
Detailed Description: In the dose-escalation phase, escalating doses of etrumadenant in combination with carboplatin and pemetrexed at standard doses (Arm A), and etrumadenant in combination with carboplatin, pemetrexed and pembrolizumab (Arm B), may be assessed in participants with advanced NSCLC. Eligible participants will receive oral administration of etrumadenant as well as IV infused carboplatin, pemetrexed, with or without pembrolizumab in this phase. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase. In the dose-expansion phase, zimberelimab in combination with carboplatin and pemetrexed (Arm 1), and etrumadenant at RDE in combination with carboplatin, pemetrexed, and zimberelimab (Arm 2) may be assessed in eligible NSCLC participants who harbor an EGFR mutation and have progressed on EGFR Tyrosine Kinase Inhibitor (TKI) treatment(s). Overall duration of treatment will depend on how well the treatment is tolerated. Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Tucson, Arizona, United States
Florida Cancer Specialists - South, Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute, Tavares, Florida, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
USO Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers), Spokane, Washington, United States
St Vincent Hospital of the Catholic University of Korea, Suwon-si, Gyeonggi-do, Korea, Republic of
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
CHA Bundang Medical Center, CHA University, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Centre, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, , Korea, Republic of
Seoul National University Hospital, Suwon, , Korea, Republic of
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Changhua Christian Hospital, Changhua, , Taiwan
Taipei Medical University - Shuang Ho Hospital, New Taipei City, , Taiwan
Chi Mei Hospital, Liouying, Tainan City, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Contact Details
Name: Medical Director
Affiliation: Arcus Biosciences, Inc.
Role: STUDY_DIRECTOR
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