RecruitingPhase 3NCT06956001

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

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


Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

300 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new EGFR-targeting drug called firmonertinib to standard platinum-based chemotherapy as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that has specific uncommon EGFR mutations (called PACC or L861Q mutations). These mutations are less common and may respond differently than the typical EGFR mutations. **You may be eligible if...** - You are 18 or older with locally advanced or metastatic non-squamous NSCLC (stage IIIB, IIIC, or IV) - Your tumor has a confirmed PACC or L861Q EGFR mutation on central laboratory testing - You have not received any prior systemic treatment for advanced-stage disease - You are in good general health (ECOG 0 or 1) with at least one measurable tumor **You may NOT be eligible if...** - Your tumor contains a significant proportion of neuroendocrine cells (more than 10%) - You have had prior EGFR-targeted therapy for advanced disease - You do not have the specific EGFR mutations tested in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFirmonertinib 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).

DRUGPemetrexed 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).

DRUGCisplatin for injection

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

DRUGCarboplatin 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

View Full Details on ClinicalTrials.gov

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NCT06956001


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