AN0025 + Chemoradiation for Lung Cancer

Recruiting at 1 trial location

Overseen By Matthew P Deek, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Immunosuppressants, Steroids, Live vaccines, others

Disqualifiers: Pregnancy, Autoimmune disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

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

Research Team

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for adults over 18 with Stage III Non-Small Cell Lung Cancer who can perform daily activities, have adequate organ function and lung capacity. They must not be pregnant or breastfeeding, agree to use contraception, and cannot have a second active cancer or severe allergies to the treatment components.

Inclusion Criteria

I can do my usual activities or only light work due to my condition.

I agree to use contraception or abstain from sex during and for 120 days after treatment.

My lungs are working well.

Exclusion Criteria

I have a history of lung scarring or fibrosis.

I do not have serious heart problems like recent heart failure or uncontrolled high blood pressure.

I weigh less than 66 lbs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive AN0025 in combination with chemoradiation therapy

Concurrent with treatment cycles

Visits on specified days during treatment cycles

Consolidation

Participants receive durvalumab following chemoradiation

Concurrent with treatment cycles

Visits on specified days during treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Post-study follow-up every three months

Treatment Details

Interventions

• AN0025

Trial Overview The trial tests AN0025's safety and effectiveness when given during and after chemoradiation therapy in patients with Stage III NSCLC. It looks at how well it works by measuring time without disease progression, response rate, survival times, and drug levels in the body.

Participant Groups

Group I: AN0025: Dose level two: 375 mg daily Experimental Treatment 1 Intervention

Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration

Group II: AN0025: Dose level one: 250 mg daily Experimental Treatment 1 Intervention

Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Adlai Nortye Biopharma Co., Ltd.

Industry Sponsor

Trials

8

Recruited

740+