Spots Global Cancer Trial Database for Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
Official Title: A Phase II Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
Study ID: NCT05617313
Study Description
Brief Summary: This open-label, non-randomized Phase II trial is designed to assess the safety and tolerability of GT103 in combination with pembrolizumab in adult subjects with relapsed or refractory, metastatic NSCLC. The study will consist of a safety lead-in of 10-20 patients. A total of 50 patients will be treated with the combination at the safest dose of GT103 as determined in the safety lead-in. If 10 additional patients are enrolled to the dose level -1 then the maximum of 60 subjects may be accrued to this trial.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Illinois Cancer Center, Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
Karmanos Cancer Center (Wayne State University), Detroit, Michigan, United States
Summit Health, Berkeley Heights, New Jersey, United States
Duke Cancer Institute, Durham, North Carolina, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Contact Details
Name: Jeffrey Clarke, MD
Affiliation: Duke Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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