Last updated: January 12, 2022
Sponsor: Tongji University
Overall Status: Active - Recruiting
Phase
2
Condition
Non-small Cell Lung Cancer
Treatment
N/AClinical Study ID
NCT05165355
SGHDOT 21-12
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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) 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:
- 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 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
ChinaActive - Recruiting
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