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
- Hwasun, Incheon, Seoul, and Suwon, South KoreaSee the 7 sites
- Phase
- Phase 3
Where in South Korea
- Chonnam National University Hwasun HospitalHwasun, South KoreaTaking people
- Gachon University Gil Medical CenterIncheon, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Kangbuk Samsung HospitalSeoul, South KoreaTaking people
- Kyung Hee University HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- The Catholic University of Korea St. Vincent's HospitalSuwon, South KoreaTaking 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?
Trial 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.