Gefitinib Versus Pemetrexed for Previously Treated NSCLC... | NCT01783834

Studies
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

NCT01783834

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Feb 11, 2016Estimated

Enrollment

95Actual

Phase

Phase 2

Conditions

Previous Treated Metastatic Non-small Cell Lung Cancer

Interventions

Gefitinib
Pemetrexed

Countries

South Korea

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Feb 4, 2013

First Posted Date

Feb 5, 2013Estimated

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

Feb 10, 2016

Last Update Posted Date

Feb 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eun Kyung Cho, professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer

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

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pemetrexed	Active Comparator	pemetrexed	Drug: Pemetrexed
gefitinib	Active Comparator	gefitinib	Drug: Gefitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug	compare progression free survivla rate and safety to both drugs	gefitinib

Measure	Description	Time Frame
Overall response rate		5 years

Measure	Description	Time Frame
Progression free survival		5years

Measure	Description	Time Frame
Number of participants with adverse events		5years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
second line
ECOG 0～2
Patients with normal liver function and renal function

Exclusion Criteria:

Patients with severe acute infection requiring antibiotic therapy
Patients who have received treatment in other areas of cancer within 5 years
During pregnancy and lactation patients

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon university Gil Medical Center		Incheon			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077156	Gefitinib
D000068437	Pemetrexed

Ancestor Terms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

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Browse Branches

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