Back to resultsChemotherapy of NSCLC With or Without Icotinib
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icotinib
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing completely resection of EGRF mutation-positive NSCLC
- Staging ⅠB (with high risk factor) to ⅢA
- PS = 0 or 1
- Adequate hematological, biochemical and organ functions
Exclusion Criteria:
- Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Chemotherapy
Chemotherapy & Icotinib
Arm Description
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity.
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
Number of Participants with Adverse Effects
Full Information
NCT ID
NCT02430974
First Posted
April 26, 2015
Last Updated
April 26, 2015
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02430974
Brief Title
Chemotherapy of NSCLC With or Without Icotinib
Official Title
Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
5. Study Description
Brief Summary
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
No Intervention
Arm Description
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).
Arm Title
Chemotherapy & Icotinib
Arm Type
Experimental
Arm Description
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention Description
Patients in experimental group will receive oral Icotinib for 4-8months.
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Effects
Time Frame
duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing completely resection of EGRF mutation-positive NSCLC
Staging ⅠB (with high risk factor) to ⅢA
PS = 0 or 1
Adequate hematological, biochemical and organ functions
Exclusion Criteria:
Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaican Cai, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26474174
Citation
Feng S, Wang Y, Cai K, Wu H, Xiong G, Wang H, Zhang Z. Randomized Adjuvant Chemotherapy of EGFR-Mutated Non-Small Cell Lung Cancer Patients with or without Icotinib Consolidation Therapy. PLoS One. 2015 Oct 16;10(10):e0140794. doi: 10.1371/journal.pone.0140794. eCollection 2015.
Results Reference
derived
Learn more about this trial
Chemotherapy of NSCLC With or Without Icotinib
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