Tests firmonertinib against standard drugs in lung cancer with rare EGFR mutations
Tests firmonertinib in adults with advanced lung cancer and rare EGFR mutations.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Kaohsiung City, Taichung, and Taipei, TaiwanSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lung cancer (NSCLC) that has spread or cannot be treated by surgery or radiotherapy, and that has an uncommon EGFR PACC mutation. They must not have had treatment yet for advanced disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer that cannot be cured by surgery or radiotherapy
- Earlier treatment
- No earlier systemic anticancer treatment for advanced disease, including any EGFR-targeting drug. Earlier treatment before surgery or after surgery for non-metastatic disease is allowed only if at least 12 months have passed without treatment.
- Biomarker or test result
- An EGFR PACC mutation from the record's list, found in tumor tissue or blood by local testing
Main reasons for not taking part
- Earlier systemic anticancer treatment for advanced lung cancer
- Earlier treatment with any EGFR-targeting drug, such as an EGFR TKI or antibody
- Neo-adjuvant or adjuvant treatment for non-metastatic disease ended less than 12 months ago
Read by machine on 12 November 2026.
Where in Taiwan
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanContact: Clinical TrialsTaking people
- Taichung Veterans General HospitalTaichung, TaiwanContact: Clinical TrialsTaking people
- National Taiwan University Cancer CenterTaipei, TaiwanContact: Clinical TrialsTaking people
- Taipei Veterans General HospitalTaipei, TaiwanContact: Clinical TrialsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- ArriVent BioPharma, Inc.
- Trial code
- NCT07185997
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
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.