Chemotherapy of NSCLC With or Without Icotinib

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02430974

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Icotinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Chemotherapy 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).
Experimental: Chemotherapy & Icotinib 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.	Drug: Icotinib Patients in experimental group will receive oral Icotinib for 4-8months.

Arm

Intervention/Treatment

No Intervention: Chemotherapy

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).

Experimental: Chemotherapy & Icotinib

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.

Drug: Icotinib

Patients in experimental group will receive oral Icotinib for 4-8months.

Outcome Measures

Primary Outcome Measures

Disease free survival [from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years]

Secondary Outcome Measures

Number of Participants with Adverse Effects [duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

Principal Investigator: Kaican Cai, MD, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT02430974

Other Study ID Numbers:

NFYYXWK-CKC1102

First Posted:

Apr 30, 2015

Last Update Posted:

Apr 30, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 30, 2015