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RECRUITING
NCT06652048
PHASE2

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

Sponsor: Jialei Wang

View on ClinicalTrials.gov

Summary

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.

Official title: High-dose Furmonertinib or Combined With Pemetrexed and Carboplatin/Cisplatin in EGFR-sensitive Mutation Advanced NSCLC After Disease Progression on First-line Treatment of Third-generation EGFR-TKI:a Multicencer,Open-label,Randomized Phase II Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-01

Completion Date

2027-12

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Furmonertinib 160mg QD

All patients enrolled into this group will receive furmonertinib 160mg p.o qd.

DRUG

Furmonertinib 240mg QD

All patients enrolled into this group will receive furmonertinib 240mg p.o qd.

DRUG

Furmonertinib 160mg QD plus Chemotherapy

All patients enrolled into this group will receive furmonertinib 160mg furmonertinib p.o qd plus chemotherapy\[(carboplatin AUC 5 / cisplatin 75mg/m2+ pemetrexed 500mg/m2) every 21 days ×4 cycles + pemetrexed 500mg/m2 every 21 days maintenance\]

Locations (1)

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China