Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

Phase 3CompletedNCT01207011

Sumitomo Pharma Co., Ltd.202 enrolled

Overview

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Lung Cancer

Interventions

Amrubicin hydroclorideDRUG

AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.

DocetaxelDRUG

DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) * 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy * 20 or older but younger than 75 years of age Exclusion Criteria: * Symptomatic brain metastasis * Interstitial pneumonia or pulmonary fibrosis * Abnormal cardiac function or myocardial infraction within 6 months before study enrollment * Active infection

Locations (1)

32 Sites

Multiple Locations, Japan

Outcomes

Primary Outcomes

Progression free survival

Time frame: 3.3 months

Secondary Outcomes

Overall survival

Time frame: 12 months

response rate (RECIST)

Time frame: 3 months

Number of Participants with Adverse Events

Time frame: 4 months

Data from ClinicalTrials.gov

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