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Chemotherapy of NSCLC With or Without Icotinib

NCT ID: NCT02430974

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

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

Interventions

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Icotinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaican Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

References

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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.

Reference Type DERIVED
PMID: 26474174 (View on PubMed)

Other Identifiers

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NFYYXWK-CKC1102

Identifier Type: -

Identifier Source: org_study_id