OncoMatch/Clinical Trials/NCT06674343
Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations
Is NCT06674343 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Furmonertinib for advanced or metastatic non-small cell lung cancer.
Treatment: Furmonertinib — To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Excluded: ALK fusion
Excluded: BRAF mutation
Excluded: KRAS mutation
Excluded: MET mutation
Excluded: NTRK1 fusion
Excluded: NTRK2 fusion
Excluded: NTRK3 fusion
Excluded: RET rearrangement
Excluded: ROS1 fusion
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antitumor therapy
Patients had locally advanced NSCLC or metastatic NSCLC without any systemic antitumor therapy
Cannot have received: irradiation to >30% bone marrow or large area
Having been irradiated for > 30% bone marrow or a large area within 4 weeks prior to the first dose of investigational product
Cannot have received: major surgery
Exception: surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy
Having received major surgery within 4 weeks prior to the first dose of investigational product or plan to receive major surgery during the study with exception of the surgical procedures to establish vascular access, biopsy through mediastinoscopy or thoracoscopy
Cannot have received: potent CYP3A4 inhibitor
Use of a potent CYP3A4 inhibitor within 7 days prior to the first dose of investigational product
Cannot have received: potent CYP3A4 inducer
potent CYP3A4 inducer within 21 days prior to the first dose of investigational product
Cannot have received: traditional Chinese medicine with tumor indication or adjuvant anti-tumor effect
use of the traditional Chinese medicine or traditional Chinese medicine preparation with tumor indication, or traditional Chinese medicine or traditional Chinese medicine preparation with adjuvant anti-tumor effect within two weeks prior to the first dose of investigational product or expected to be required during the study
Cannot have received: investigational product or device
Having participated in the clinical trial and received the investigational product or device within 4 weeks or at least 5 half-lives prior to the first dose of investigational product
Cannot have received: other anti-tumor drugs
Having received other anti-tumor drugs within 14 days prior to the first dose of investigational product
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; HGB ≥ 90 g/L
Kidney function
CrCL ≥ 50 mL/min (according to Cockcroft-Gault formula)
Liver function
TBIL ≤ 1.5 times ULN, AST and ALT ≤ 2.5 times ULN (with liver metastasis, TBIL ≤ 3 times ULN, AST and ALT ≤ 5 times ULN)
Cardiac function
QTc > 470 ms on ECG at resting state; clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval
Adequate organ function as shown in the laboratory test, including: (1) ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; HGB ≥ 90 g/L; (2) TBIL ≤ 1.5 times ULN, AST and ALT ≤ 2.5 times ULN (with liver metastasis, TBIL ≤ 3 times ULN, AST and ALT ≤ 5 times ULN); (3) CrCL ≥ 50 mL/min (according to Cockcroft-Gault formula); QTc > 470 ms on ECG at resting state; clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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