NCT02737774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

3.5 years

First QC Date

April 5, 2016

Last Update Submit

June 30, 2020

Conditions

Lung Adenocarcinoma

Keywords

IcotinibchemotherapyEGFR

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    from the day confirmed NSCLC to the day of first detecting progression, up to 24 months

Secondary Outcomes (1)

  • overall survival time

    from the day confirmed NSCLC to the day of death, up to 36 months

Study Arms (1)

Icotinib and Pemetrexed/Carboplatin

EXPERIMENTAL

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: IcotinibDrug: Pemetrexed/Carboplatin

Interventions

IcotinibDRUG

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.

Icotinib and Pemetrexed/Carboplatin
Pemetrexed/CarboplatinDRUG

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.

Icotinib and Pemetrexed/Carboplatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)。

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

Related 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: 10.1177/030089161309900331.

    PMID: 24158081BACKGROUND

  • 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.

    PMID: 25093093BACKGROUND

  • 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.

    PMID: 24980828BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

icotinibPemetrexedCarboplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCoordination ComplexesOrganic Chemicals

Study Officials

  • Qiming Wang, Ph.D

    Henan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 14, 2016

Study Start

April 13, 2016

Primary Completion

October 25, 2019

Study Completion

June 1, 2021

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)