First-line Treatment With Icotinib in Elder NSCLC EGFR Mu... | NCT01646450

Studies
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients

NCT01646450

Sponsor

Betta Pharmaceuticals Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 9, 2015Estimated

Enrollment

35Estimated

Phase

Phase 4

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 19, 2012

First Posted Date

Jul 20, 2012Estimated

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

Sep 5, 2015

Last Update Posted Date

Sep 9, 2015Estimated

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

A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

Detailed Description

A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.

Primary endpoint to assess progression-free survival
Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Icotinib	Experimental	Icotinib: 125mg, oral administration, three times per day.	Drug: Icotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Icotinib	Drug	Icotinib: 125mg, oral administration, three times per day.	Icotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival	PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
Positive EGFR Mutation.
No previous systemic anticancer therapy.
Male and female patients aged over 70 years.
Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Provision of written informed consent.

Exclusion Criteria:

Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Known severe hypersensitivity to icotinib or any of the excipients of this product.
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han Baohui, MD	Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity		Shanghai	Shanghai Municipality	200030	China

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