AN0025 + Chemoradiation for Lung Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, AN0025, combined with chemoradiation for advanced non-small cell lung cancer. Researchers aim to determine if adding AN0025 helps patients live longer without disease progression and improves their response to treatment. The study has two parts: one examines the effects of taking AN0025 during chemoradiation, and the other investigates taking it afterward. If you have locally advanced or metastatic Stage III non-small cell lung cancer and can perform most daily tasks, this trial might be suitable for you. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AN0025 is likely to be safe for humans?

Research has shown that AN0025 has potential for safety and effectiveness based on earlier trials. In one study, patients received AN0025 alongside other treatments, and it appeared well-tolerated. Most patients did not experience severe side effects that required stopping the treatment.

Another study involving patients who used AN0025 for a longer duration than their previous treatments also demonstrated encouraging safety results, indicating no major problems for these patients.

Overall, early data suggests that AN0025 is generally safe when combined with other cancer treatments. However, as this is an early phase trial, further research is necessary to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AN0025 for lung cancer because it represents a novel approach by potentially enhancing the effects of chemoradiation. Unlike standard treatments like chemotherapy and radiation alone, AN0025 is taken orally and is designed to be administered just before these therapies, possibly making them more effective. This drug could amplify the body's response to treatment by targeting specific pathways involved in cancer growth, which is a different mechanism compared to traditional therapies. This unique approach offers hope for improved outcomes in lung cancer patients.

What evidence suggests that AN0025 might be an effective treatment for lung cancer?

Research has shown that AN0025, one of the treatments studied in this trial, appears promising for treating lung cancer when combined with chemoradiation. One study found that combining AN0025 with standard chemoradiotherapy was safe and showed early signs of effectiveness in patients with advanced lung cancer. This combination might also enhance the effectiveness of immunotherapy, a treatment that helps the body's immune system fight cancer. Although these results are preliminary, they suggest that AN0025 could improve outcomes for lung cancer patients by potentially slowing the disease and increasing survival times. It is important to note that these are initial findings, and further research is underway to confirm these benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. healthcare.utah.edu healthcare.utah.edu/huntsmancancerinstitute/press-releases/2020/12/treats-first-non-small-cell-lung-cancer-patient-new-clinical-trial

Treats First Non-Small Cell Lung Cancer Patient on New ... "This trial combines immunotherapy with another agent, AN0025, which has the potential to improve response to immunotherapy." Clinical trials ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04432857

NCT04432857 | AN0025 and Pembrolizumab Combination ... This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e16076

AN0025 in combination with definitive chemoradiotherapy ... This Phase Ib study suggests that AN0025 plus dCRT exhibits favorable safety and encouraging preliminary efficacy in unresectable locally advanced or locally ...

4. withpower.com withpower.com/trial/phase-1-stage-iii-lung-cancer-4-2022-695e2

AN0025 + Chemoradiation for Lung Cancer 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937135/

Update 2025: Management of Non‑Small-Cell Lung Cancer NSCLC, which constitutes the majority of lung cancer cases, has historically been associated with poor outcomes due to its often late diagnosis ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)03643-7/pdf

1030TiP An open-label multicenter phase ... 10 patients received AN0025 treatment longer than their most recent prior therapy, including 2 immunotherapy patients (Hong DS, et al. J.