Non-Small-Cell Lung Cancer study: Firmonertinib
Official title 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
ClinicalTrials.gov ID: NCT07185997
What this study is testing
What is Firmonertib?
Firmonertib is an investigational oral tablet being studied as a potential treatment for non‑small‑cell lung cancer with EGFR PACC mutations. Firmonertib is designed to block abnormal EGFR signaling that can drive tumor growth.
Also referred to as AST2818.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if firmonertinib is as effective and safe as current standard treatments for people with a specific genetic change in their lung cancer.
- Who it's for
- People with advanced non-small-cell lung cancer that has a specific EGFR mutation and who have not yet received treatment for this stage of the disease.
- What's involved
- Participants will take one daily pill. Some will take the new drug firmonertinib, while others will take a standard drug like osimertinib or afatinib.
- Time commitment
- The study involves regular visits to the clinic for check-ups and tests to monitor how the body is responding to the treatment.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or...
- 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...
- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have...
- Patients with asymptomatic CNS metastases are eligible.
See the full 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...
- 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.
- List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K E709\_T710delinsD, E709\_T710delinsA, E709\_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740\_K745dup...
The study team makes the final eligibility decision.
Where it is enrolling
- Fullerton, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Vallejo, California, United States
- Aurora, Colorado, United States
- Arlington Heights, Illinois, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Lake Success, New York, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
- Winchester, Virginia, United States
- Edmonds, Washington, United States
+ 94 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fullerton, California, United States; Los Angeles, California, United States; Orange, California, United States; Sacramento, California, United States; San Francisco, California, United States; Vallejo, California, United States and 108 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.