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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed plus cisplatin; Drug: Gemcitabine plus cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01401192

2011-06-006

Details and patient eligibility

About

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

Enrollment: 304 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 4 patient groups

TS positive cohort & Gem/Cis Tx arm

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine plus cisplatin

Drug: Gemcitabine plus cisplatin

TS+ cohort & Pem/Cis arm

Active Comparator group

Description:

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

Treatment:

Drug: pemetrexed plus cisplatin

Drug: pemetrexed plus cisplatin

TS negative cohort & Pem/Cis Tx arm

Active Comparator group

Description:

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

Treatment:

Drug: pemetrexed plus cisplatin

Drug: pemetrexed plus cisplatin

TS negative cohort & Gem/Cis Tx arm

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine plus cisplatin

Drug: Gemcitabine plus cisplatin