Overview
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
Status:
Unknown status
Unknown status
Trial end date:
2018-09-01
2018-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Betta Pharmaceuticals Co.,Ltd.
Criteria
Inclusion Criteria:- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients
confirmed by sputum cytology)
- Positive EGFR 21 exon mutation or 19 exon deletion
- Age 18-75 years old with performance status of 0 to 2
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography
(CT)and >=20mm with conventional CT) according to RECIST Criteria
- Adequate hematological, biochemical and organ functions.
Exclusion Criteria:
- Severe systemic disease out of control such as unstable or uncompensated
respiratory,cardiac,liver,renal diseases.
- Evidence of interstitial lung diseases
- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study