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

  • STATUS
    Recruiting
  • End date
    Feb 25, 2025
  • participants needed
    90
  • sponsor
    Tongji University
Updated on 25 March 2022
carcinoma
growth factor
epidermal growth factor receptor
EGFR
cancer chemotherapy
epidermal growth factor
lung carcinoma

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

Details
Condition NSCLC, EGF-R Positive Non-Small Cell Lung Cancer
Treatment Furmonertinib
Clinical Study IdentifierNCT05165355
SponsorTongji University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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