NCT06029816

Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Convalife (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-arm, open-label, multicenter phase II clinical study

Detailed description

Fourteen patients each had three mutation sites and 42 patients were co-enrolled，To evaluate the objective response rate (ORR) of neratinib Tablets in advanced NSCLC with rare EGFR mutations (including G719X, E709X in exon 18, S768I in exon 20 and L861Q in exon 21).

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Neratinib tablets	Neratinib tablets

Timeline

• Start date: 2023-11-20
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2023-09-08
• Last updated: 2023-09-08

Locations

1 site across 1 country: China