Actively Recruiting
Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PaCC or L861Q Mutation
Led by Allist Pharmaceuticals, Inc. · Updated on 2026-02-12
300
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of firmonertinib mesylate compared with platinum-based chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have specific EGFR mutations (PaCC or l861q). This phase III, randomized, open, multicenter clinical study focuses on patients who have not previously received systemic antitumor therapy. Eligible patients are grouped by mutation type and the presence of central nervous system metastasis at enrollment. Participants are randomly assigned to receive either oral firmonertinib mesylate at 240 mg once daily on an empty stomach or platinum-containing dual-agent chemotherapy. The chemotherapy includes intravenous pemetrexed disodium (500 mg/m2), cisplatin (75 mg/m2), or carboplatin (based on AUC 5 mg/ml), given in 21-day cycles with up to four cycles for platinum drugs. Treatment continues until intolerable toxicity, disease progression, or other specified reasons. During the study, participants undergo assessments including tumor response evaluated by an independent committee using RECIST v1.1 criteria, safety monitoring for adverse events, and quality of life questionnaires (EORTC QLQ LC13 and QLQ-C30). Blood samples will be collected to measure drug levels. The main outcome measured is progression-free survival over up to three years, with follow-up including overall survival and safety evaluations.
CONDITIONS
Brief Title
Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Histologically or cytologically confirmed non-squamous NSCLC, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) per UICC/AJCC 8th edition
- At least one measurable lesion by RECIST v1.1 with no prior local therapy or biopsy during screening
- No prior systemic therapy for advanced/metastatic NSCLC; prior (neo)adjuvant or definitive chemoradiotherapy allowed if completed at least 12 months before progression
- Confirmed EGFR PaCC or L861Q mutation by central lab; agreement to provide recent tumor tissue and blood samples
- ECOG performance status 0-1
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function within 14 days prior to treatment
- 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 are met
You will not qualify if you...
- Tumors with more than 10% neuroendocrine, sarcomatoid, or squamous cell components
- Presence of certain targetable gene alterations with approved therapies (ALK, ROS1, RET, NTRK, BRAF V600E, MET exon 14 skipping)
- Prior systemic anti-tumor therapy for advanced/metastatic NSCLC (exceptions apply for prior adjuvant/neoadjuvant therapy)
- Thoracic radiotherapy >30 Gy within 6 months or non-thoracic radiotherapy within 4 weeks prior to starting treatment (exceptions for brain radiotherapy)
- Previous EGFR-targeted therapies including investigational agents
- Use of strong CYP3A4 inhibitors within 7 days or inducers within 21 days before first dose
- Use of anticancer traditional Chinese medicine or non-specific immunomodulators within 2 weeks before first dose
- Major trauma or surgery within 4 weeks before treatment
- Significant gastrointestinal abnormalities affecting drug swallowing or absorption
- Uncontrolled systemic diseases or severe infections
- History or current interstitial lung disease or non-infectious pneumonia
- Significant cardiovascular dysfunction
- Tumor invasion of critical structures with high bleeding or fistula risk
- Severe pulmonary comorbidities or autoimmune diseases affecting lungs
- Residual toxicity >Grade 1 from prior cancer therapy (except alopecia or neuropathy)
- Concurrent malignancies except certain cured localized cancers
- Pregnancy, lactation, or planned pregnancy within 6 months after treatment
- Inability to comply with study procedures or follow-up
- Known hypersensitivity to study drugs or their components
- History of allergic reactions to pemetrexed, cisplatin, or carboplatin
- Other exclusions per investigator judgment including substance abuse, severe comorbidities, laboratory abnormalities, or social factors compromising safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until intolerable toxicity, loss of clinical benefit, disease progression, death, or other anti-tumor treatment
Participants receive either Firmonertinib orally once daily or platinum-based chemotherapy intravenously every 21 days in cycles. Treatment continues until intolerable toxicity, loss of clinical benefit, disease progression, death, or other anti-tumor treatment.
Visits every 3 weeks corresponding to treatment cycles
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
Research Team
S
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
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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