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Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
Sponsor: Allist Pharmaceuticals, Inc.
Summary
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 platinum containing dual agent chemotherapy.
Official title: A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-11-19
Completion Date
2028-07
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Firmonertinib Mesilate Tablets
Usage and dosage: oral, 240mg, QD。 Medication duration: 21 days as a cycle, until intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Pemetrexed Disodium for Injection
Usage and dosage: 500mg/m2, intravenous infusion. Medication duration: 21 days as a cycle, D1 administration, until the occurrence of intolerable toxicity, loss of clinical benefit, disease progression (confirmed by BICR), death or other anti-tumor treatment (whichever occurs first).
Cisplatin for injection
Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Carboplatin Injection
Usage and dosage: give the drug according to AUC 5 mg/ml, intravenous drip. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
Locations (2)
Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Shandong Tumor Hospital
Shandong, Jinan, China