OncoMatch/Clinical Trials/NCT06652048
High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI
Is NCT06652048 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Furmonertinib 160mg QD and Furmonertinib 240mg QD for non-small cell lung cancer.
Treatment: Furmonertinib 160mg QD · Furmonertinib 240mg QD · Furmonertinib 160mg QD plus Chemotherapy — This is a multicenter, open-label,randomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKI.Eligible patients will randomly be assigned in a 1:1:1 ratio to receive 160mg/240mg furmonertinib p.o qd or 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\].Patients will be followed up every 2 cycles during the first half year , and every 3 cycles after the first half year.Treatment was continued until disease progression,intolerable toxic effects, investigator decision, patient withdrawal of consent, or death, whichever occurred first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR sensitizing mutation
Excluded: BRAF v600e
Excluded: MET amplification
Excluded: RET fusion
Disease stage
Metastatic disease required
Locally advanced or metastatic non-small cell lung cancer ; Patient has at least one accurately measurable lesion ... according to RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: third-generation EGFR TKI (osimertinib, almonertinib, furmonertinib) — first-line
Developed radiological progression after first-line third-generation EGFR-TKI monotherapy without any other subsequent systemic therapy. Patients received Osimertinib or Almonertinib for at least 3 months prior to progression and were discontinued 8 days prior to randomization, patients received Furmonertinib prior to progression achieved remission or sustained clinical benefit for at least 6 months (progression occurred during or <6 months after the last dose when the third-generation EGFR-TKI as a neoadjuvant/adjuvant, EGFR-TKI is considered as first-line treatment)
Cannot have received: systemic anti-tumor therapy other than third-generation EGFR-TKI
Received any systemic anti-tumor therapy other than third-generation EGFR-TKI (including anti-tumor drugs in clinical research) before the first dose
Cannot have received: cytotoxic chemotherapy with significant delayed toxicity (mitomycin C, nitrosoureas)
received cytotoxic drugs with significant delayed toxicity, such as mitomycin C and nitrosoureas, within 6 weeks before the first dose
Cannot have received: non-specific immunomodulators (interferon, IL-2)
Received non-specific immunomodulators (including but not limited to interferon, IL-2), Chinese medicine or Chinese medicine preparations approved for anti-tumor indications within 2 weeks prior to initial administration
Lab requirements
Blood counts
lack of adequate bone marrow reserve or organ function excluded
Kidney function
Liver function
Cardiac function
Mean resting corrected QT interval (QTc)>470 msec, any clinically important ECG abnormalities, LVEF<50%, history of myocardial infarction, severe or unstable angina, coronary artery bypass surgery, or cardiac insufficiency ≥ NYHA Level 2 within the last 6 months excluded
Examination within 28 days prior to administration of the first investigational drug revealed a lack of adequate bone marrow reserve or organ function；Any condition meets the following cardiac standard: Mean resting corrected QT interval (QTc)>470 msec, obtained from 3 ECG, using the screening clinic ECG machine-derived QTc value. Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second-degree heart block；Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval. Echocardiographic examination: LVEF<50%，history of myocardial infarction, severe or unstable angina pectoris, coronary artery bypass surgery, or cardiac insufficiency ≥ NYHA Level 2 within the last 6 months；
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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