EGF-R Positive Non-Small Cell Lung Cancer, NSCLC
Conditions
Keywords
NSCLC, EGFR mutation, adjuvant therapy
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
Interventions
DRUGFurmonertinib
Furmonertinib (80 mg orally, once daily) for 3 years.
Sponsors
Tongji University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactJiang Fan, MD
Backup ContactXiao-Long Li, MD
Outcome results
None listed