Clinical trial NCT05165355: Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
EGF-R Positive Non-Small Cell Lung Cancer
Keywords: NSCLC
EGFR mutation
adjuvant therapy
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Disease Free Survival (DFS) rate at 2 years
timeFrame: 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:
measure: Disease Free Survival (DFS)
timeFrame: 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.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiang Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: