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RECRUITING
NCT06192849
PHASE2

To Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

Sponsor: Juan LI, MD

View on ClinicalTrials.gov

Summary

This is a phase II, prospective, multi-centre study. To assess the efficacy and safety of furmonertinib in patients with epidermal growth factor receptor 20ins mutation positive stage IB-IIIA Non-small Cell Lung Carcinoma, following complete tumour resection with or without adjuvant chemotherapy. The study plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years. The primary endpoint is DFS. The secondary endpoint include DFS rate , OS and the change of HRQoL. In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Official title: A Phase II, Prospective, Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-12-31

Completion Date

2027-01-31

Last Updated

2024-01-05

Healthy Volunteers

No

Interventions

DRUG

Furmonertinib

This arm plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years.

Locations (1)

Sichuan cancer hospital

Chengdu, Sichuan, China