Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Jialei Wang |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 60 |
| Start date | 2024-10-01 |
| Completion | 2027-12 |
Conditions
- Non-Small Cell Lung Cancer
Interventions
- Furmonertinib 160mg QD
- Furmonertinib 240mg QD
- Furmonertinib 160mg QD plus Chemotherapy
Primary outcomes
- Progression-free survival (PFS) — Up to 2 years
Progression-free survival (PFS) assessed by INV per RECIST v1.1 in the FAS population.
Countries
China