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

Primary Purpose

Lung Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib
Pemetrexed/Carboplatin
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma focused on measuring Icotinib, chemotherapy, EGFR

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henan cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib and Pemetrexed/Carboplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

overall survival time

Full Information

First Posted
April 5, 2016
Last Updated
June 30, 2020
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02737774
Brief Title
Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Official Title
A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2016 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma
Keywords
Icotinib, chemotherapy, EGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib and Pemetrexed/Carboplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed/Carboplatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
Secondary Outcome Measure Information:
Title
overall survival time
Time Frame
from the day confirmed NSCLC to the day of death, up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan cancer hospital
City
Zhengzhou
State/Province
Henan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24158081
Citation
Sun X, Zheng Y. Retreatment with icotinib in a patient with metastatic lung adenocarcinoma. Tumori. 2013 May-Jun;99(3):e124-6. doi: 10.1177/030089161309900331.
Results Reference
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PubMed Identifier
25093093
Citation
Zheng Y, Fang W, Deng J, Zhao P, Xu N, Zhou J. Sequential treatment of icotinib after first-line pemetrexed in advanced lung adenocarcinoma with unknown EGFR gene status. J Thorac Dis. 2014 Jul;6(7):958-64. doi: 10.3978/j.issn.2072-1439.2014.07.18.
Results Reference
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PubMed Identifier
24980828
Citation
Wang DS, Patel A, Shukla S, Zhang YK, Wang YJ, Kathawala RJ, Robey RW, Zhang L, Yang DH, Talele TT, Bates SE, Ambudkar SV, Xu RH, Chen ZS. Icotinib antagonizes ABCG2-mediated multidrug resistance, but not the pemetrexed resistance mediated by thymidylate synthase and ABCG2. Oncotarget. 2014 Jun 30;5(12):4529-42. doi: 10.18632/oncotarget.2102.
Results Reference
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Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation

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