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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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NSCLC, EGF-R Positive Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Furmonertinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Furmonertinib (80 mg orally, once daily) for 3 years. | Drug: Furmonertinib<br>* Furmonertinib (80 mg orally, once daily) for 3 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, EGFR mutation, adjuvant therapy