Firmonertinib for Lung Cancer

Recruiting at 2 trial locations

Overseen By Vanessa Esquibel

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ArriVent BioPharma, Inc.

Must not be taking: EGFR-targeting agents

Disqualifiers: Prior systemic therapy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or death, assessed up to approximately 4 years

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether firmonertinib, a targeted therapy, is more effective than other treatments for non-small cell lung cancer (NSCLC) with a specific mutation (EGFR PACC mutation). It compares firmonertinib to osimertinib and afatinib to determine which best stops cancer growth. Candidates may qualify if they have this type of lung cancer that cannot be treated with surgery or radiation and have not received advanced cancer treatment before. The trial seeks participants with the specific mutation to identify a more effective treatment option. As a Phase 3 trial, it represents the final step before FDA approval, offering patients access to potentially groundbreaking treatment.

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

The trial does not specify if you need to stop taking your current medications. However, it does require that you have not received any prior therapy for advanced lung cancer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that firmonertinib is generally well-tolerated. A study with 53 patients found that most did not experience severe side effects. Mild to moderate side effects were more common, but serious issues were rare. This suggests firmonertinib is likely safe for patients with specific lung cancer mutations.

Osimertinib, another treatment option in the trial, is already approved for similar lung cancer cases. Past studies have shown it to be generally safe, though it can cause side effects like diarrhea and skin rash. Afatinib is also approved and known to be well-tolerated, though it may cause side effects like diarrhea and mouth sores.

Overall, these treatments have undergone extensive study, and their safety profiles are well-documented. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Firmonertinib is unique because it targets lung cancer in a novel way compared to existing treatments like osimertinib and afatinib, which are also EGFR-TKI inhibitors. What sets firmonertinib apart is its potential to overcome resistance that often develops with these standard therapies. Researchers are excited about firmonertinib because it promises not only to effectively inhibit cancer cell growth but also to improve patient outcomes by addressing this resistance issue. This could mean a longer-lasting and more effective treatment option for those battling lung cancer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that firmonertinib, which participants in this trial may receive, may effectively treat non-small cell lung cancer (NSCLC) in patients with certain EGFR mutations. In one study, patients lived for a median of 16 months without their cancer worsening. The disease control rate was 100%, meaning all patients in that study experienced either cancer stabilization or shrinkage. Another study found that when the drug was effective, it remained so for an average of 14.6 months. This evidence suggests that firmonertinib could be a strong option for people with this type of lung cancer. Additionally, this trial will compare firmonertinib to an EGFR-TKI inhibitor, either osimertinib or afatinib, based on the investigator's choice. ^{1 2 4 6 7}

Who Is on the Research Team?

Morgan Lam

Principal Investigator

ArriVent BioPharm

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have specific EGFR PACC mutations and haven't had previous systemic cancer treatments. Those with prior non-metastatic treatment must have a 12-month gap since last therapy. Patients with stable brain metastases may participate.

Inclusion Criteria

My lung cancer cannot be cured with surgery or radiation.

My cancer has a specific EGFR mutation.

I haven't received any treatments for advanced NSCLC, including EGFR-targeting therapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive firmonertinib or investigator's choice of osimertinib or afatinib daily

Until progression or death, assessed up to approximately 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Assessed up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Firmonertinib

Trial Overview The study compares the new drug Firmonertinib to existing EGFR inhibitors, Osimertinib or Afatinib, in treating NSCLC. Participants will be randomly assigned to one of the drugs and take it daily to assess effectiveness and safety.

How Is the Trial Designed?

Group I: Firmonertinib 240 mg Experimental Treatment 1 Intervention

Group II: EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice Active Control 1 Intervention

Who Is Running the Clinical Trial?

ArriVent BioPharma, Inc.

Lead Sponsor

Trials

2

Recruited

550+

Citations

1. ir.arrivent.com ir.arrivent.com/news-releases/news-release-details/arrivent-presents-final-analysis-firmonertinib-monotherapy-data

Release Details 16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)03519-7/fulltext

1975P Effectiveness and safety of firmonertinib in non- ... Firmonertinib showed encouraging efficacy in NSCLC patients with uncommon EGFR mutations and a manageable safety, supporting further clinical exploration.

3. onclive.com onclive.com/view/dr-le-on-the-efficacy-of-firmonertinib-for-the-treatment-of-egfr-pacc-mutated-nsclc

Dr Le on the Efficacy of Firmonertinib for the Treatment ... Additionally, the median duration of response (DOR) was 14.6 months, the disease control rate (DCR) was 100% (95% CI, 84.6%-100%), and the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12076557/

Efficacy and safety of furmonertinib in patients with EGFR ... Using a data cut-off of July 2024, disease progression or death was observed in 16 patients (64.0%), whilst 9 patients (36.0%) remained progression-free. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425019501

A Study of Firmonertinib in TKI-Naive, Advanced NSCLC ... Updated FURTHER trial results demonstrate promising antitumor activity in 1L EGFR PACC mutant NSCLC patients treated with firmonertinib including prolonged DoR ...

6. iaslc.org iaslc.org/iaslc-news/press-release/results-further-trial-demonstrate-firmonertinib-promising-potential

Results from the FURTHER Trial Demonstrate ... Firmonertinib showed promising efficacy in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting with central nervous ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425025894

EP.12.08 A Real-World Study of the Efficacy and Safety ... Building on these findings, this study aims to evaluate the real-world efficacy and safety of firmonertinib in patients with locally advanced or metastatic ...