Sichuan cancer hospital
Chengdu, Sichuan, 610000, China
Location status: Recruiting
NCT Number: NCT06192849
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Chengdu, Sichuan, 610000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years
Disease-free-survival
Time frame: From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2,3,5 years.
Disease free survival (DFS) rate at 2, 3 and 5 years
Time frame: From date of receiving therapy until date of death (by any cause in the absence of recurrence).Approximately 5 years following the first dose of study drugs
Overall Survival
Juan LI, MD
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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