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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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).
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).
Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.
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.
Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGShandong Tumor Hospital
Shandong, Jinan, China
RECRUITINGProgression-free survival (PFS) assessed by the Independent Review Committee (BICR) according to RECIST v1.1.
The time from the date of randomization to the date of first documentation of disease progression (assessed according to RECIST v1.1 criteria) or death from any cause, whichever occurred first.
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
The incidence and severity of adverse events (AES) were determined according to NCI CTCAE V5.0
Time frame: Up to 3 years
Patient Reported Outcomes by EORTC QLQ LC13 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame: Up to 3 years
Patient Reported Outcomes by EORTC QLQ-C30 questionnaire
To assess the impact of firmonertinib on patients' disease-related symptoms and health related quality of life (HRQoL).
Time frame: Up to 3 years
Plasma concentrations of firmonertinib and its major metabolite (ast5902) in patients treated with firmonertinib at the indicated sampling time points
Time frame: Up to 3 years
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
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