Study of Chemotherapy Plus Icotinib to Treat EGFR Mutatio... | NCT02272127

Studies
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

NCT02272127

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Oct 22, 2014Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

NSCLC

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

Oct 2014

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

Jul 2014

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Sep 27, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 22, 2014Estimated

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

Oct 20, 2014

Last Update Posted Date

Oct 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kaican Cai, Chief Physician，Associate Professor, Nanfang Hospital, Southern Medical UniversityPrincipal Investigator

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intercalated treatment	Experimental	Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects	Drug: icotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
icotinib	Drug		intercalated treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease free survival		from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Effects		duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing completely resection of EGRF mutation-positive NSCLC
Staging ⅠB (with high risk factor) to ⅢA
PS<2
Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kaican Cai, MD	Contact	8620-61641822		doc_cai@163.com
Siyang Feng, MM	Contact			fengsy89@163.com

Overall Officials

Name	Affiliation	Role
Kaican Cai, MD	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital of Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

Intervention Browse Module

MeSH Terms

ID	Term
C531470	icotinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided