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A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants

Lung Cancer Stage III Clinical Trial

Official title:
A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants

Clinical Trial Summary

Primary - Evaluate safety and toxicity of AN0025 in both the consolidative setting (after chemoradiation) and in the concurrent setting (during chemoradiation) - Evaluate efficacy by progression-free survival (PFS), objective response rate (ORR), and time to death or distant metastasis (TTMD), Duration of response (DOR), Overall survival (OS) with the addition of AN0025 in both the consolidative and concurrent settings Exploratory - Evaluate pharmacokinetics of AN0025 in conjunction with chemoradiation, and then with durvalumab

Clinical Trial Description

The purpose of the research is to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in advanced (Stage III) Non-Small Cell Lung Cancer. Participant will receive the experimental combination of drugs (AN0025, chemoradiation and durvalumab) and undergo laboratory tests and study procedures on specified days during the study period. Complete end of study evaluations and tests, and participate in post-study follow up every three months for two years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits. Possible benefits of taking part may be improvement in your condition and slowing or stopping the growth of your cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05358691
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact Salma K Jabbour, MD
Phone (732) 253-3939
Email jabbousk@cinj.rutgers.edu
Status Not yet recruiting
Phase Phase 1
Start date January 30, 2024
Completion date June 1, 2028
View Details
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