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

NCT06956001 | Recruiting Phase 3 DMC

• 1 other identifier: ALSC013AST2818
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

firmonertinib

Outcome Measures

Primary Outcomes (1)

• Progression-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.

  Up to 3 years

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 3 years

• The incidence and severity of adverse events (AES) were determined according to NCI CTCAE V5.0

  Up to 3 years

• Patient Reported Outcomes by EORTC QLQ LC13 questionnaire

  Up to 3 years

• Patient Reported Outcomes by EORTC QLQ-C30 questionnaire

  Up to 3 years

• Plasma concentrations of firmonertinib and its major metabolite (ast5902) in patients treated with firmonertinib at the indicated sampling time points

  Up to 3 years

Study Arms (2)

Firmonertinib

EXPERIMENTAL

Oral administration, 240mg, QD。

Drug: Firmonertinib Mesilate Tablets

chemotherapy

ACTIVE COMPARATOR

Pemetrexed Disodium for Injection： 500mg/m2, intravenous infusion. Cisplatin for injection：75 mg/m2， intravenous infusion. Carboplatin Injection：administered according to the AUC of 5 mg/ml, intravenous infusion.

Drug: Pemetrexed Disodium for Injection; Drug: Cisplatin for injection; Drug: Carboplatin Injection

Interventions

Cisplatin for injection DRUG

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

chemotherapy

Firmonertinib Mesilate Tablets DRUG

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).

Firmonertinib

Pemetrexed Disodium for Injection DRUG

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).

chemotherapy

Carboplatin Injection DRUG

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.

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form (ICF).
• Age ≥18 years at the time of ICF signing.
• 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
• 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)
• Agreement to provide:
• Recent tumor tissue (from untreated lesions)
• Blood samples
• Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)
• No prior systemic therapy for advanced/metastatic NSCLC.
• Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
• ECOG performance status 0-1.

You may not qualify if:

• Histologically/cytologically confirmed tumor with \>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.
• 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.
• Prior treatments including:
• Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).
• Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.
• Anticancer traditional Chinese medicines within 2 weeks prior to first dose.
• Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.
• Major trauma/surgery within 4 weeks prior to treatment initiation.
• Clinically significant gastrointestinal abnormalities, including:
• Moderate/severe atrophic gastritis
• GI obstruction/perforation
• Chronic diarrhea/short bowel syndrome
• Major upper GI surgery (e.g., gastrectomy)
• Inflammatory bowel disease (Crohn's/ulcerative colitis) or active intestinal inflammation
• Inability to swallow tablets

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (2)

Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Shandong Tumor Hospital

Shandong, Jinan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Injections; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 2, 2025
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-03

Locations

CN (2)