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

NCT06956001 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

  • EGFR
  • NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

DRUG

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).

DRUG

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).

DRUG

Cisplatin for injection

Usage and dosage: 75 mg/m2, i.v. Medication duration: 21 days as a cycle, D1 administration, up to 4 cycles.

DRUG

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.

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06956001 on ClinicalTrials.gov