Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma

Phase 2

Recruiting

• Conditions: NSCLC; EGF-R Positive Non-Small Cell Lung Cancer
• Interventions: Drug: Furmonertinib

• Registration Number: NCT05165355
• Lead Sponsor: Tongji University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-21
• Study Start: 2021-12-28
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-18
• Primary Completion: 2024-11
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Subjects aged ≥18 and ≤75 years old；
2. ECOG performance status score 0-1；
3. Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
4. Complete surgical resection of the primary NSCLC is mandatory；
5. Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces [STAS], etc.);
6. The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
7. Normal organ and bone marrow function measured before the study as defined below:

1. 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 8. 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; 9. Subjects have voluntarily participated, signed and dated informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Furmonertinib	Furmonertinib (80 mg orally, once daily) for 3 years.

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS) rate at 2 years	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 Outcome Measures

Name	Time	Method
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.	Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS).

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China