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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: pemetrexed plus cisplatin; Drug: Gemcitabine plus cisplatin

• Registration Number: NCT01401192
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Last Update Submitted: 2011-07-22
• Study First Posted: 2011-07-25
• Last Update Posted: 2011-07-25
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS+ cohort & Pem/Cis arm	pemetrexed plus cisplatin	Among patients with TS+, randomised to Pem/cis chemotherapy
TS negative cohort & Pem/Cis Tx arm	pemetrexed plus cisplatin	Among patients with TS-, some will be randomised to Pem/cis Tx arm
TS negative cohort & Gem/Cis Tx arm	Gemcitabine plus cisplatin	Among patients with TS-, some will be randomised to Gem/Cis Tx arm
TS positive cohort & Gem/Cis Tx arm	Gemcitabine plus cisplatin	Among TS expression positive patients, some will be randomized to Gem/cis therapy

Primary Outcome Measures

Name	Time	Method
predictive value of TS expression	12 months	To determine the predictive value of thymidylate synthase expression in NSCLC patients treated with pemetrexed combination therapy by interaction P value

Secondary Outcome Measures

Name	Time	Method
response rate	12 months	Whether the response rate of CP regimen is higher than that of CG regimen in TS- patients

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of