Status:
UNKNOWN
Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib mai...
Eligibility Criteria
Inclusion
- Stage IV or IIIB advanced non-small cell lung cancer patients
- Positive EGFR Mutation
- Non-progressive disease after first-line gemcitabine/cisplatin therapy
- Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Exclusion
- Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
- Patients with wild-type EGFR
- Evidence of interstitial lung diseases
- Severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02194556
Start Date
July 1 2014
End Date
July 1 2017
Last Update
July 18 2014
Active Locations (1)
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1
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021