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

Recruiting now · Phase 3

Conditions studied: EGFR, NSCLC (Advanced Non-small Cell Lung Cancer)

In brief

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.

Key facts

Study ID

NCT06956001

Run by

Allist Pharmaceuticals, Inc.

People needed

300

Starts

2024-11-19

Expected to finish

2028-07-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Life expectancy ≥12 weeks.
• Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior).
• Women of childbearing potential (WOCBP):
• Abstinence or contraception use
• No egg donation
• Non-sterilized males:
• Abstinence or contraception use
• No sperm donation
• CNS metastases allowed if protocol-specified criteria are met.

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:
• Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6.
• >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).
• 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
• Uncontrolled systemic diseases.
• Severe acute/chronic infections.
• Interstitial lung disease (ILD)/non-infectious pneumonia:
• History requiring clinical intervention
• Current presence
• Suspicious imaging findings unresolved at screening
• Clinically significant cardiovascular dysfunction (active or history).
• Tumor invasion of critical adjacent structures (heart/esophagus/SVC etc.) with high bleeding/fistula risk. Exceptions may be considered if investigator assesses minimal risk.

Where it is running

• Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Shandong Tumor Hospital — Shandong, Jinan, China (enrolling)

Full record on ClinicalTrials.gov

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