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

NCT ID: NCT05165355

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2025-02-28

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Furmonertinib

Intervention Type: DRUG

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

Interventions

Furmonertinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Jiang Fan

Director of department of thoracic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Fan, MD

Role: CONTACT

fan_jiang@tongji.edu.cn

15901013210

Xiao-Long Li, MD

Role: CONTACT

lixl_810@outlook.com

15121035752

Facility Contacts

Jiang Fan, MD

Role: primary

fan_jiang@tongji.edu.cn

02163240090

Other Identifiers

SGHDOT 21-12

Identifier Type: -

Identifier Source: org_study_id