Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- 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
- Stage IV or IIIB advanced non-small cell lung cancer patients
- Positive EGFR Mutation
Exclusion Criteria
- Patients with wild-type EGFR
- 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
- 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 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
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
- 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
- Stage IV or IIIB advanced non-small cell lung cancer patients
- Positive EGFR Mutation
Exclusion Criteria
- Patients with wild-type EGFR
- 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
- 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 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
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
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