High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI

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 aft

Trial Details

NCT ID

NCT06652048

Phase

PHASE2

Sponsor

Jialei Wang

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Furmonertinib 160mg QD
Furmonertinib 240mg QD
Furmonertinib 160mg QD plus Chemotherapy

Locations (sample)

Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

Locally advanced or metastatic non-small cell lung cancer ;
Histologically or haematologically confirmed EGFR-sensitive mutations;
Developed radiological progression after first-line third-generation EGFR-TKI monotherapy without any other subsequent systemic therapy. Patients r…
Patient has at least one accurately measurable lesion that has not been previously irradiated or biopsied during the screening period, according to…

For full eligibility, visit ClinicalTrials.gov.

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