AN0025: Dose level two: 375 mg daily for Stage III Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Stage III Lung Cancer
AN0025 - Drug
Eligibility
18+
All Sexes
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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

1 of 3

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

1 of 3

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: Drug
AN0025: Dose level one: 250 mg daily
Drug
Experimental Group · 1 Intervention: AN0025 · Intervention Types: Drug

Trial 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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.