Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 nonsmall-cell-lung-cancer
Started Nov 2016
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 6, 2016
CompletedFirst Posted
Study publicly available on registry
November 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedNovember 11, 2016
November 1, 2016
1.1 years
November 6, 2016
November 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
progression-free survival
10 months
Secondary Outcomes (2)
tumor response rate
2 months
overall survival
24 months
Study Arms (1)
icotinib
EXPERIMENTALpatients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
Interventions
Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 6, 2016
First Posted
November 10, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2017
Study Completion
August 1, 2018
Last Updated
November 11, 2016
Record last verified: 2016-11