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

NCT ID: NCT02737774

Last Updated: 2020-07-01

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-13

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Qiming Wang

director

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type BACKGROUND
PMID: 24158081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25093093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24980828 (View on PubMed)

Other Identifiers

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HenanCH HX3001

Identifier Type: -

Identifier Source: org_study_id

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