A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)
New Lung Cancer Drug Trial for Specific Genetic Mutations
Plain English Summary
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations is a Phase 3 clinical trial sponsored by ArriVent BioPharma, Inc. studying Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC, EGFR Uncommon Mutations. This trial tests a new drug called firmonertinib against standard treatments for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has certain genetic mutations. Participants will receive either firmonertinib or a doctor-chosen standard drug, with treatment assigned randomly. Standard treatments for this type of lung cancer include targeted therapies like osimertinib or afatinib. The trial aims to enroll 480 participants.
Official Summary
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer that has spread or cannot be removed by surgery or radiation. Must have a confirmed specific genetic mutation in their lung cancer called EGFR PACC. Cannot have received any prior treatment for advanced lung cancer, including other targeted therapies. Patients with brain metastases that are not causing symptoms may be eligible. This trial is studying Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC, EGFR Uncommon Mutations, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if firmonertinib helps patients live longer without their cancer getting worse, or if it shrinks tumors more effectively than current options. The specific primary outcome measures are: Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Until progression or death, assessed up to approximately 4 years); Confirmed overall response rate (ORR) as determined by BICR (Until progression or death, assessed up to approximately 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a need for new treatments for lung cancer patients with rare EGFR mutations, potentially offering a more effective first-line therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC, EGFR Uncommon Mutations, where improved treatment options are needed.
Investor Insight
This trial targets a specific, unmet need in the lung cancer market, with potential for a new first-line treatment if successful, indicating a significant investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if your lung cancer has the specific EGFR PACC mutation and if this trial is a good fit for you. Participation involves receiving study medication daily and attending regular clinic visits for monitoring and tests. You will be randomly assigned to receive either the new drug or a standard treatment. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 480 participants
Interventions
- DRUG: Firmonertinib — 240 mg oral, daily firmonertinib tablet
- DRUG: EGFR-TKI inhibitor based on investigator's choice — osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
Primary Outcomes
- Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Until progression or death, assessed up to approximately 4 years)
- Confirmed overall response rate (ORR) as determined by BICR (Until progression or death, assessed up to approximately 3 years)
Secondary Outcomes
- Overall survival (OS) (Until death, assessed up to approximately 5 years)
- Investigator-assessed PFS (Until progression or death, assessed up to approximately 4 years)
- Investigator-assessed confirmed ORR (Until progression or death, assessed up to approximately 3 years)
- Duration of response (DOR) (Until progression or death, assessed up to approximately 4 years)
- Time to second Progression-free survival (PFS2) (Assessed up to approximately 5 years)
Full Eligibility Criteria
Key Eligibility Criteria: * Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing. * No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies). * Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months. * Patients with asymptomatic CNS metastases are eligible.
Trial Locations
- USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
- University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
- UCSF Medical Center-Mission Bay, San Francisco, California, United States
- Kaiser Permanente Medical Center, Vallejo, California, United States
- Illinois Cancer Specialists, Arlington Heights, Illinois, United States
- University of Illinois Hospital and Health Sciences Systems, Chicago, Illinois, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
- Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
- Texas Oncology, Dallas, Texas, United States
- The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07185997?
NCT07185997 is a Phase 3 INTERVENTIONAL study titled "Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations." It is currently recruiting and is sponsored by ArriVent BioPharma, Inc.. The trial targets enrollment of 480 participants.
What conditions does NCT07185997 study?
This trial investigates treatments for Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC, EGFR Uncommon Mutations. The primary condition under study is Non-Small-Cell Lung Cancer.
What treatments are being tested in NCT07185997?
The interventions being studied include: Firmonertinib (DRUG), EGFR-TKI inhibitor based on investigator's choice (DRUG). 240 mg oral, daily firmonertinib tablet
What does Phase 3 mean for NCT07185997?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07185997?
This trial is currently "Recruiting." It started on 2025-12-17. The estimated completion date is 2030-12.
Who is sponsoring NCT07185997?
NCT07185997 is sponsored by ArriVent BioPharma, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07185997?
The trial aims to enroll 480 participants. The trial is currently recruiting and accepting new participants.
How is NCT07185997 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07185997?
The primary outcome measures are: Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Until progression or death, assessed up to approximately 4 years); Confirmed overall response rate (ORR) as determined by BICR (Until progression or death, assessed up to approximately 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07185997 being conducted?
This trial is being conducted at 20 sites, including Los Angeles, California; Sacramento, California; San Francisco, California; Vallejo, California and 16 more sites (United States, Australia, Canada).
Where can I find official information about NCT07185997?
The official record for NCT07185997 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07185997. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07185997 testing in simple terms?
This trial tests a new drug called firmonertinib against standard treatments for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has certain genetic mutations.
Why is this trial significant?
This trial addresses a need for new treatments for lung cancer patients with rare EGFR mutations, potentially offering a more effective first-line therapy. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07185997?
Common side effects may include diarrhea, rash, and mouth sores. Serious side effects can occur, and your medical team will monitor you closely. There is a risk that the treatment may not be effective or could cause unexpected reactions. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07185997?
Ask your doctor if your lung cancer has the specific EGFR PACC mutation and if this trial is a good fit for you. Participation involves receiving study medication daily and attending regular clinic visits for monitoring and tests. You will be randomly assigned to receive either the new drug or a standard treatment. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07185997 signal from an investment perspective?
This trial targets a specific, unmet need in the lung cancer market, with potential for a new first-line treatment if successful, indicating a significant investment opportunity. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either firmonertinib or a doctor-chosen standard drug, with treatment assigned randomly. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.