OncoMatch/Clinical Trials/NCT06956001
Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation
Is NCT06956001 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Firmonertinib Mesilate Tablets and Pemetrexed Disodium for for egfr.
Treatment: Firmonertinib Mesilate Tablets · Pemetrexed Disodium for · Cisplatin for · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR PACC mutation
Central lab-confirmed EGFR PACC or L861Q mutation
Required: EGFR L861Q
Central lab-confirmed EGFR PACC or L861Q mutation
Excluded: ALK fusion
Known ALK-positive
Excluded: ROS1 fusion
Known ROS1-positive
Excluded: RET fusion
RET fusion-positive
Excluded: NTRK1 fusion
NTRK fusion-positive
Excluded: NTRK2 fusion
NTRK fusion-positive
Excluded: NTRK3 fusion
NTRK fusion-positive
Excluded: BRAF V600E
BRAF V600E mutation
Excluded: MET exon 14 skipping mutation
MET exon 14 skipping mutation
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
Exception: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
No prior systemic therapy for advanced/metastatic NSCLC. Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression
Cannot have received: EGFR-targeted therapy
Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.)
Cannot have received: chemotherapy
Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy)
Cannot have received: immunotherapy
Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy)
Cannot have received: thoracic radiotherapy
Exception: ≤30 Gy thoracic radiotherapy within 6 months prior to first dose
>30 Gy thoracic radiotherapy within 6 months prior to first dose
Cannot have received: non-thoracic radiotherapy
Exception: brain radiotherapy exceptions per Inclusion Criterion #12
non-thoracic radiotherapy within 4 weeks prior to first dose
Cannot have received: strong CYP3A4 inhibitors
Strong CYP3A4 inhibitors within 7 days prior to first dose
Cannot have received: strong CYP3A4 inducers
Strong CYP3A4 inducers within 21 days prior to first dose
Cannot have received: anticancer traditional Chinese medicines
Anticancer traditional Chinese medicines within 2 weeks prior to first dose
Cannot have received: non-specific immunomodulators (interferon, IL-2, thymosin)
Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose
Lab requirements
Blood counts
Adequate bone marrow function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior)
Kidney function
Adequate organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior)
Liver function
Adequate organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior)
Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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