Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02961270

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Icotinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: icotinib patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity	Drug: Icotinib Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity

Arm

Intervention/Treatment

Experimental: icotinib

patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity

Drug: Icotinib

Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity

Outcome Measures

Primary Outcome Measures

progression-free survival [10 months]

Secondary Outcome Measures

tumor response rate [2 months]
overall survival [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with stage IIIB/IV non-small cell lung cancer
Patients with uncommon epidermal growth factor receptor (EGFR) mutation
Targeted-therapy-naive patients
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Evaluable target lesions according to RECIST 1.1 for tumour response assessment

Exclusion Criteria:

Wild-type EGFR
Positive 19 del and/or 21 L858R mutation
Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib
Patients who have documented history of interstitial lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs	Beijing		China	100021

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Study Chair: Shengyu Zhou, MD, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shengyu Zhou, Director, Chinese Academy of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02961270

Other Study ID Numbers:

CAMS-ZH-001

First Posted:

Nov 10, 2016

Last Update Posted:

Nov 11, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 11, 2016