A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.

Tongji University1 site in 1 country90 target enrollmentDecember 28, 2021

ConditionsNSCLC EGF-R Positive Non-Small Cell Lung Cancer

InterventionsFurmonertinib

DrugsFurmonertinib

Overview

Phase: Phase 2
Intervention: Furmonertinib
Conditions: NSCLC
Sponsor: Tongji University
Enrollment: 90
Locations: 1
Primary Endpoint: Disease Free Survival (DFS) rate at 2 years
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.

The primary endpoint: 2-year DFS rate; The second endpoint: DFS

Registry

clinicaltrials.gov

Start Date

December 28, 2021

End Date

February 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tongji University

Responsible Party

Principal Investigator

Jiang Fan

Director of department of thoracic surgery

Tongji University

Eligibility Criteria

Inclusion Criteria

•Subjects aged ≥18 and ≤75 years old；
•ECOG performance status score 0-1；
•Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
•Complete surgical resection of the primary NSCLC is mandatory；
•Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces \[STAS\], etc.);
•The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
•Normal organ and bone marrow function measured before the study as defined below:
•Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0\~10×10\^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10\^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio（INR）≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN
•No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded;
•Subjects have voluntarily participated, signed and dated informed consent.

Exclusion Criteria

•Double primary lung cancer or multiple primary lung cancer;
•Subjects with mental illness;
•Presence or concomitant hemorrhagic diseases;
•Pregnancy or lactation;
•Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.

Arms & Interventions

Experimental group

Furmonertinib (80 mg orally, once daily) for 3 years.

Intervention: Furmonertinib

Outcomes

Primary Outcomes

Disease Free Survival (DFS) rate at 2 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. Assessed at 2 years.

Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.

Secondary Outcomes

Disease Free Survival (DFS)(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.)