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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401192

Enrollment

304

Registered

2011-07-25

Start date

2011-07-31

Completion date

Unknown

Last updated

2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

thymidylate synthase

Brief summary

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

Interventions

DRUGGemcitabine plus cisplatin

Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks

DRUGpemetrexed plus cisplatin

Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
response rate	12 months	Whether the response rate of CG regimen is higher than that of CP regimen in TS+ patients

Countries

South Korea

Contacts

Primary ContactMyung-Ju Ahn, Pf

silkahn@skku.edu822-3410-3459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026