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

Last updated: January 12, 2022
Sponsor: Tongji University
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05165355
SGHDOT 21-12
  • Ages 18-75
  • All Genders

Study 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

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) Absolutevalue of neutrophil (ANC)≥1.5×10^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum totalbilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalizedratio(INR)≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serumcreatinine (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 DFSwere excluded; 9. Subjects have voluntarily participated, signed and dated informedconsent.

Exclusion

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 theirpreparations.

Study Design

Total Participants: 90
Study Start date:
December 28, 2021
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Active - Recruiting

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