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Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06956001•Allist Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent form (ICF).
•2. Age ≥18 years at the time of ICF signing.
•3. At least one measurable lesion per RECIST v1.1, meeting the following:
•* No prior local therapy (e.g., radiotherapy)
•* Not used for biopsy during screening
•4. Histologically/cytologically confirmed non-squamous NSCLC, classified as:
•* Locally advanced (Stage IIIB/IIIC, unsuitable for curative surgery and/or definitive chemoradiotherapy)
•* Metastatic (Stage IV) (Based on UICC/AJCC 8th edition TNM staging)
•5. Agreement to provide:
•* Recent tumor tissue (from untreated lesions)
+14 more criteria

Exclusion Criteria

•1. Histologically/cytologically confirmed tumor with \>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.
•2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.
•3. Prior treatments including:
•1. Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6.
•2. \>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).
•3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).
•4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.
•5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.
•6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.
•7. Major trauma/surgery within 4 weeks prior to treatment initiation.
+31 more criteria

Locations (2)

Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Shandong Tumor Hospital

Shandong, Jinan, China

Key Dates

Start Date

November 19, 2024

Primary Completion Date

December 1, 2027

Completion Date

July 1, 2028

Last Updated

February 12, 2026

Enrollment

300

ESTIMATED participants

Conditions

EGFRNSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

Firmonertinib Mesilate Tablets

DRUG

Pemetrexed Disodium for Injection

DRUG

Cisplatin for injection

DRUG

Carboplatin Injection

DRUG

Contacts

Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd

CONTACT

021-80423288 zhenhua.gong@allist.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC

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