Icotinib for Completed Resected IB NSCLC With EGFR Mutation (NCT02264210) | Clinical Trial Compass
CompletedPhase 2
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
China128 participantsStarted 2015-01
Plain-language summary
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Written informed consent provided.
* Males or females, Aged 18-75 years.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
* EGFR activating mutation in exon 19 or 21.
* Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
* ECOG performance status of 0-1.
* Had a life expectancy of 12 weeks or more.
* Adequate hematological function, adequate liver function and renal function.
* Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
Exclusion Criteria:
* Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
* Inability to comply with protocol or study procedures.
* Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
* Any evidence confirmed tumor recurrence before investigational therapy.
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of clinically active interstitial lung disease.
* Eye inflammation not fully controlled or conditions predisposing the subject to this.
* Any unstable systemic disease (including active…
What they're measuring
1
3-year Disease-Free Survival
Timeframe: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years