Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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

Exclusion Criteria

Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Severe hypersensitivity to icotinib or any of the excipients of this product.
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
Severe hypersensitivity to icotinib or any of the excipients of this product.
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

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

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

Exclusion Criteria

Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Severe hypersensitivity to icotinib or any of the excipients of this product.
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
Severe hypersensitivity to icotinib or any of the excipients of this product.
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

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