Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

Henan Cancer Hospital60 enrolled

Overview

This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Adenocarcinoma

Interventions

IcotinibDRUG

Pemetrexed/CarboplatinDRUG

All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin (standard solution, 3 weeks for a cycle of chemotherapy : pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.). After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ. 2. Positive EGFR mutation(19 exon or 21 exon)。 Exclusion Criteria: 1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. 2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. 3. Allergic to icotinib 4. metastases of spinal cord, meninges or meningeal.

Locations (1)

Henan cancer hospital

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

Progression Free Survival

Time frame: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months

Secondary Outcomes

overall survival time

Time frame: from the day confirmed NSCLC to the day of death, up to 36 months

Data from ClinicalTrials.gov

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