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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02737774
• Other study ID #: HenanCH HX3001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 13, 2016
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ?B or phase ?.

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Henan cancer hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Sun X, Zheng Y. Retreatment with icotinib in a patient with metastatic lung adenocarcinoma. Tumori. 2013 May-Jun;99(3):e124-6. doi: 10.1700/1334.14820. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
Secondary	overall survival time		from the day confirmed NSCLC to the day of death, up to 36 months