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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

RecruitingPhase 3Ages 18 Years - anyAllArriVent BioPharma, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Firmonertinib
  • EGFR-TKI inhibitor based on investigator's choice
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Where

139 sites
St. Jude Medical Center
Fullerton, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
Providence St. Joseph Hospital
Orange, United States
University of California Davis Comprehensive Cancer Center
Sacramento, United States
UCSF Medical Center-Mission Bay
San Francisco, United States
Kaiser Permanente Medical Center
Vallejo, United States
University of Colorado Health
Aurora, United States
Illinois Cancer Specialists
Arlington Heights, United States

โ€ฆand 131 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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