Back to resultsAdjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma (ATHEM)
Primary Purpose
NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Furmonertinib
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC focused on measuring NSCLC, EGFR mutation, adjuvant therapy
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:
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:
- 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.
Sites / Locations
- Shanghai General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group
Arm Description
Furmonertinib (80 mg orally, once daily) for 3 years.
Outcomes
Primary Outcome Measures
Disease Free Survival (DFS) rate at 2 years
Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
Secondary Outcome Measures
Disease Free Survival (DFS)
Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05165355
Brief Title
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
Keywords
NSCLC, EGFR mutation, adjuvant therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Furmonertinib (80 mg orally, once daily) for 3 years.
Intervention Type
Drug
Intervention Name(s)
Furmonertinib
Intervention Description
Furmonertinib (80 mg orally, once daily) for 3 years.
Primary Outcome Measure Information:
Title
Disease Free Survival (DFS) rate at 2 years
Description
Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
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.
Secondary Outcome Measure Information:
Title
Disease Free Survival (DFS)
Description
Assess the Efficacy of Adjuvant Furmonertinib as Measured by Disease Free Survival (DFS).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Fan, MD
Phone
15901013210
Email
fan_jiang@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Long Li, MD
Phone
15121035752
Email
lixl_810@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Fan, MD
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Fan, MD
Phone
02163240090
Email
fan_jiang@tongji.edu.cn
First Name & Middle Initial & Last Name & Degree
Jiang Fan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
We'll reach out to this number within 24 hrs