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

Sponsor

Henan Cancer Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02737774

Collaborator

(none)

Enrollment

Location

Arm

61.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma	Drug: Icotinib Drug: Pemetrexed/Carboplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

Actual Study Start Date :

Apr 13, 2016

Actual Primary Completion Date :

Oct 25, 2019

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Icotinib and Pemetrexed/Carboplatin Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles. Then continue with Icotinib, 125mg Tid，PO. until disease progression.	Drug: Icotinib 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. After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression. Drug: Pemetrexed/Carboplatin 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.

Arm

Intervention/Treatment

Experimental: Icotinib and Pemetrexed/Carboplatin

Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles. Then continue with Icotinib, 125mg Tid，PO. until disease progression.

Drug: Icotinib

Drug: Pemetrexed/Carboplatin

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.

Outcome Measures

Primary Outcome Measures

Progression Free Survival [from the day confirmed NSCLC to the day of first detecting progression, up to 24 months]

Secondary Outcome Measures

overall survival time [from the day confirmed NSCLC to the day of death, up to 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
Positive EGFR mutation(19 exon or 21 exon)。

Exclusion Criteria:

Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Allergic to icotinib
metastases of spinal cord, meninges or meningeal.