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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TS positive cohort & Gem/Cis Tx arm

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

Group Type EXPERIMENTAL

Gemcitabine plus cisplatin

Intervention Type DRUG

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

TS+ cohort & Pem/Cis arm

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

Group Type ACTIVE_COMPARATOR

pemetrexed plus cisplatin

Intervention Type DRUG

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

TS negative cohort & Pem/Cis Tx arm

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

Group Type ACTIVE_COMPARATOR

pemetrexed plus cisplatin

Intervention Type DRUG

pemetrexed 500mg/m2 \& cisplatin 70mg/m2 every 3 weeks

TS negative cohort & Gem/Cis Tx arm

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

Group Type EXPERIMENTAL

Gemcitabine plus cisplatin

Intervention Type DRUG

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

Interventions

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Gemcitabine plus cisplatin

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

Intervention Type DRUG

pemetrexed plus cisplatin

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

Intervention Type DRUG

pemetrexed plus cisplatin

pemetrexed 500mg/m2 \& cisplatin 70mg/m2 every 3 weeks

Intervention Type DRUG

Gemcitabine plus cisplatin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No