Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
NCT ID: NCT02737774
Last Updated: 2020-07-01
Study Results
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2016-04-13
2021-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Positive EGFR mutation(19 exon or 21 exon)。
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Qiming Wang
director
Principal Investigators
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Qiming Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Henan Cancer Hospital
Locations
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Henan cancer hospital
Zhengzhou, Henan, China
Countries
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References
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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.
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.
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.
Other Identifiers
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HenanCH HX3001
Identifier Type: -
Identifier Source: org_study_id
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