ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

NCT ID: NCT01810367

Last Updated: 2016-02-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

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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ABX Combined With Cisplatin

ABX,100mg/m2,d1、8、15,ivgtt,in 30 min,28day one cycle; cisplin 75mg/m2 d1 ivgtt

Group Type EXPERIMENTAL

ABX Combined With Cisplatin

Intervention Type DRUG

Gemcitabine Combined With Cisplatin

gemcitabine 1000mg/m2,d1、8;cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle.

Group Type ACTIVE_COMPARATOR

Gemcitabine Combined With Cisplatin

Intervention Type DRUG

Interventions

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ABX Combined With Cisplatin

Intervention Type DRUG

Gemcitabine Combined With Cisplatin

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Chang Jian Hua

Vice director of department of chemotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ABX-CJH

Identifier Type: -

Identifier Source: org_study_id

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