Firmonertinib versus standard EGFR drugs as first treatment for advanced NSCLC with EGFR PACC mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, randomized, multicenter, open-label Phase 3 trial assigns participants 1:1 to oral firmonertinib 240 mg once daily or investigator's choice of osimertinib 80 mg once daily or afatinib 40 mg once daily as first-line therapy for locally advanced or metastatic NSCLC with documented EGFR PACC mutations. Eligible participants must be treatment-naive for advanced disease, with prior adjuvant or neoadjuvant therapy allowed only if a treatment-free interval of at least 12 months has passed. Asymptomatic CNS metastases are permitted and patients are followed for efficacy and safety endpoints including tumor response and progression-free survival. Local testing of tumor tissue or blood is used to confirm EGFR PACC mutation status and the open-label design means both patients and investigators know the assigned treatment.

Why it matters

Who can join: the full rules

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.
* 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, I740\_K745dupIPVAIK, I744\_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768\_V769delinsIL, S768\_V769delinsIM, S768\_V769delinsPL, V769L, V769M, N771G, H773\_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750\_I759delinsPN, T751\_I759delinsN

Where it's running

• St. Jude Medical Center
  Fullerton, California, United States Recruiting
• USC/Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Providence St. Joseph Hospital
  Orange, California, United States Recruiting
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• UCSF Medical Center-Mission Bay
  San Francisco, California, United States Recruiting
• Kaiser Permanente Medical Center
  Vallejo, California, United States Recruiting

+91 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials
• Email: FURMO006CT@arrivent.com
• Phone: (888) 622-2827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.