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

NCT05165355 | Unknown Phase 2 DMC

• 1 other identifier: SGHDOT 21-12
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

EGF-R Positive Non-Small Cell Lung Cancer; NSCLC

Keywords

NSCLC; EGFR mutation; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Interventions

aflutinib

Study Officials

• Jiang Fan, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Fan, MD

CONTACT

15901013210; fan_jiang@tongji.edu.cn

Xiao-Long Li, MD

CONTACT

15121035752; lixl_810@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of thoracic surgery

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 21, 2021
• Study Start: December 28, 2021
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)