Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Positive EGFR Mutation
Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Non-progressive disease after first-line gemcitabine/cisplatin therapy
...
Positive EGFR Mutation
Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Non-progressive disease after first-line gemcitabine/cisplatin therapy
Stage IV or IIIB advanced non-small cell lung cancer patients

Exclusion Criteria

Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Patients with wild-type EGFR
...
Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Patients with wild-type EGFR
Evidence of interstitial lung diseases
Severe hypersensitivity to icotinib or any of the excipients of this product.

Summary

Conditions
  • Adenocarcinoma
  • EGFR Positive Non-small Cell Lung Cancer
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Inclusion Criteria

Positive EGFR Mutation
Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Non-progressive disease after first-line gemcitabine/cisplatin therapy
...
Positive EGFR Mutation
Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Non-progressive disease after first-line gemcitabine/cisplatin therapy
Stage IV or IIIB advanced non-small cell lung cancer patients

Exclusion Criteria

Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Patients with wild-type EGFR
...
Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Patients with wild-type EGFR
Evidence of interstitial lung diseases
Severe hypersensitivity to icotinib or any of the excipients of this product.

Tracking Information

NCT #
NCT02194556
Collaborators
Not Provided
Investigators
  • Principal Investigator: Xiaohua Hu, MD First Affiliated Hospital of Guangxi Medical University
  • Xiaohua Hu, MD First Affiliated Hospital of Guangxi Medical University