Icotinib in Non-small Cell Lung Cancer Patients With Unco... | NCT02961270

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

NCT02961270

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 11, 2016Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

Icotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Nov 6, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2016

Last Update Posted Date

Nov 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shengyu Zhou, Director, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
icotinib	Experimental	patients will be administered study drug (icotinib) until disease progression or unacceptable toxicity	Drug: Icotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icotinib	Drug	Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity	icotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression-free survival		10 months

Secondary Outcomes

Measure	Description	Time Frame
tumor response rate		2 months
overall survival		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shenyu Zhou, MD	Contact	86 13520852899		typhoonwho@126.com

Overall Officials

Name	Affiliation	Role
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 Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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	Recruiting	Beijing		100021

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C531470	icotinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided