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

NSCLC Clinical Trial

— ATHEM  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165355
• Other study ID #: SGHDOT 21-12
• Status: Recruiting
• Phase: Phase 2
• Start date: December 28, 2021
• Est. completion date: February 2025

Study information

• Verified date: January 2022
• Source: Tongji University
• Contact: Jiang Fan, MD
• Phone: 15901013210
• Email: fan_jiang[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects aged =18 and =75 years old;

2. ECOG performance status score 0-1;

3. Stage ?B-?A(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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGF-R Positive Non-Small Cell Lung Cancer
• Lung Neoplasms
• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS) rate at 2 years	Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.	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.
Secondary	Disease Free Survival (DFS)	Assess the Efficacy of Adjuvant Furmonertinib as Measured by 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.