Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06956001

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

Led by Allist Pharmaceuticals, Inc. · Updated on 2026-02-12

300

Participants Needed

2

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form
  • Age 18 years or older at consent
  • At least one measurable lesion per RECIST v1.1 without prior local therapy or biopsy use during screening
  • Histologically or cytologically confirmed non-squamous NSCLC, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) per staging guidelines
  • Agreement to provide recent tumor tissue from untreated lesions and blood samples
  • Central lab confirmation of EGFR PACC or L861Q mutation (consult sponsor if tumor tissue unavailable)
  • No prior systemic therapy for advanced/metastatic NSCLC except completed (neo)adjuvant/definitive chemoradiotherapy at least 12 months before recurrence
  • ECOG performance status 0-1
  • Life expectancy of 12 weeks or more
  • Adequate bone marrow and organ function within 14 days before treatment, with no transfusion or G-CSF within 2 weeks prior
  • Women of childbearing potential must use contraception or abstain and not donate eggs
  • Non-sterilized males must use contraception or abstain and not donate sperm
  • CNS metastases allowed if protocol criteria met
Not Eligible

You will not qualify if you...

  • Tumor with more than 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 systemic anti-tumor therapy for advanced/metastatic NSCLC except allowed neoadjuvant/adjuvant therapy
  • Thoracic radiotherapy over 30 Gy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (except brain radiotherapy per protocol)
  • Prior EGFR-targeted therapy including investigational drugs
  • Use of strong CYP3A4 inhibitors within 7 days or inducers within 21 days before first dose
  • Use of anticancer traditional Chinese medicines or non-specific immunomodulators within 2 weeks before first dose
  • Major trauma or surgery within 4 weeks before treatment start
  • Significant gastrointestinal disorders affecting swallowing or absorption
  • Uncontrolled systemic diseases or severe infections
  • Interstitial lung disease or non-infectious pneumonia history or current presence
  • Significant cardiovascular dysfunction
  • Tumor invasion with high bleeding or fistula risk
  • Severe pulmonary comorbidities or autoimmune diseases involving lungs
  • Residual toxicity greater than Grade 1 from prior anticancer therapy except alopecia or neuropathy
  • Concurrent malignancies except certain cured cancers
  • Pregnancy, lactation, or planned pregnancy within 6 months post-treatment
  • Inability to comply with study procedures or follow-up
  • Known allergies to study drugs or excipients
  • History of allergic reactions to pemetrexed, cisplatin, or carboplatin
  • Other conditions per investigator judgment including substance abuse, severe comorbidities, critical lab abnormalities, or social/family factors affecting safety or data collection

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Shandong Tumor Hospital

Shandong, Jinan, China

Actively Recruiting

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Research Team

S

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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