AN0025: Dose level two: 375 mg daily for Stage III Lung Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Stage III Lung Cancer
AN0025 - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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
Treatment Effectiveness
Effectiveness Progress
Other trials for Stage III Lung Cancer
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Two years
2 Years
Response evaluation criteria in solid tumors (RECIST 1.1) will be used as the primary measure for tumor response
2 years
Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease
Two years
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing
Trial Safety
Safety Progress
Other trials for Stage III Lung Cancer
Trial Design
2 Treatment Groups
AN0025: Dose level two: 375 mg daily
1 of 2
AN0025: Dose level one: 250 mg daily
1 of 2
Experimental Treatment
24 Total Participants · 2 Treatment Groups
Primary Treatment: AN0025: Dose level two: 375 mg daily · No Placebo Group · Phase 1
AN0025: Dose level two: 375 mg daily
Drug
Experimental Group · 1 Intervention: AN0025 · Intervention Types: DrugAN0025: Dose level one: 250 mg daily
Drug
Experimental Group · 1 Intervention: AN0025 · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: two years
Trial Background
Prof. Salma Jabbour, MD
Principal Investigator
Rutgers, The State University of New Jersey
Closest Location: Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
2013First Recorded Clinical Trial
2 TrialsResearching Stage III Lung Cancer
158 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have adequate staging of your disease.
You have locally advanced or metastatic NSCLC.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments