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

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ClinicalTrials.gov Identifier: NCT02737774
Recruitment Status : Unknown
Verified April 2016 by Qiming Wang, Henan Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Qiming Wang, Henan Cancer Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017


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.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months ]

Secondary Outcome Measures :
  1. overall survival time [ Time Frame: from the day confirmed NSCLC to the day of death, up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737774


Contacts
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Contact: Qiming Wang, Ph.D 0086+13783590691 qimingwang1006@163.com
Contact: Yufeng Wu, Ph.D 0086+18695829280 yufengwu@vip.qq.com

Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Qiming Wang, Ph.D Henan Cancer Hospital

Publications:
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Responsible Party: Qiming Wang, director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT02737774     History of Changes
Other Study ID Numbers: HenanCH HX3001
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qiming Wang, Henan Cancer Hospital:
Icotinib
chemotherapy
EGFR
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors