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Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine plus cisplatin
pemetrexed plus cisplatin
pemetrexed plus cisplatin
Gemcitabine plus cisplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring thymidylate synthase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed nonsquamous NSCLC
  • Stage IIIb, IV or recurrent NSCLC
  • Age ≥ 18years
  • ECOG performance status of 0 to 1
  • Known TS immunohistochemical analysis data
  • At least one measurable lesion by RECIST 1.1
  • No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
  • Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
  • At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
  • Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

  • Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
  • Patients with post-obstructive pneumonia or uncontrolled serious infection

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

TS positive cohort & Gem/Cis Tx arm

TS+ cohort & Pem/Cis arm

TS negative cohort & Pem/Cis Tx arm

TS negative cohort & Gem/Cis Tx arm

Arm Description

Among TS expression positive patients, some will be randomized to Gem/cis therapy

Among patients with TS+, randomised to Pem/cis chemotherapy

Among patients with TS-, some will be randomised to Pem/cis Tx arm

Among patients with TS-, some will be randomised to Gem/Cis Tx arm

Outcomes

Primary Outcome Measures

predictive value of TS expression
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

Secondary Outcome Measures

response rate
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
response rate
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients

Full Information

First Posted
July 21, 2011
Last Updated
July 22, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01401192
Brief Title
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression
Official Title
A Randomized Phase II Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Non-squamous Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
thymidylate synthase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TS positive cohort & Gem/Cis Tx arm
Arm Type
Experimental
Arm Description
Among TS expression positive patients, some will be randomized to Gem/cis therapy
Arm Title
TS+ cohort & Pem/Cis arm
Arm Type
Active Comparator
Arm Description
Among patients with TS+, randomised to Pem/cis chemotherapy
Arm Title
TS negative cohort & Pem/Cis Tx arm
Arm Type
Active Comparator
Arm Description
Among patients with TS-, some will be randomised to Pem/cis Tx arm
Arm Title
TS negative cohort & Gem/Cis Tx arm
Arm Type
Experimental
Arm Description
Among patients with TS-, some will be randomised to Gem/Cis Tx arm
Intervention Type
Drug
Intervention Name(s)
Gemcitabine plus cisplatin
Intervention Description
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
pemetrexed plus cisplatin
Intervention Description
Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
pemetrexed plus cisplatin
Intervention Description
pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine plus cisplatin
Intervention Description
Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
Primary Outcome Measure Information:
Title
predictive value of TS expression
Description
To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value
Time Frame
12 months
Secondary Outcome Measure Information:
Title
response rate
Description
Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients
Time Frame
12 months
Title
response rate
Description
Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed nonsquamous NSCLC Stage IIIb, IV or recurrent NSCLC Age ≥ 18years ECOG performance status of 0 to 1 Known TS immunohistochemical analysis data At least one measurable lesion by RECIST 1.1 No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy Adequate renal function: estimated creatinine clearance ≥ 50mL/min Exclusion Criteria: Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy. Patients with post-obstructive pneumonia or uncontrolled serious infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, Pf
Phone
822-3410-3459
Email
silkahn@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jong-Mu Sun, M.D., Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26124486
Citation
Sun JM, Ahn JS, Jung SH, Sun J, Ha SY, Han J, Park K, Ahn MJ. Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin According to Thymidylate Synthase Expression in Nonsquamous Non-Small-Cell Lung Cancer: A Biomarker-Stratified Randomized Phase II Trial. J Clin Oncol. 2015 Aug 1;33(22):2450-6. doi: 10.1200/JCO.2014.59.9324. Epub 2015 Jun 29.
Results Reference
derived

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Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

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