Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation

This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation. Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or

Trial Details

NCT ID
NCT06956001
Phase
PHASE3
Sponsor
Allist Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Firmonertinib Mesilate Tablets
  • Pemetrexed Disodium for Injection
  • Cisplatin for injection
  • Carboplatin Injection
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Shandong, Jinan, China|40.28464,120.48412

Key Eligibility Criteria

  • Voluntarily sign the informed consent form (ICF).
  • Age ≥18 years at the time of ICF signing.
  • At least one measurable lesion per RECIST v1.1, meeting the following:
  • No prior local therapy (e.g., radiotherapy)

For full eligibility, visit ClinicalTrials.gov.

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