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

Phase 3

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Amrubicin hydrocloride; Drug: Docetaxel

• Registration Number: NCT01207011
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Study Start: 2010-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 AMR	Amrubicin hydrocloride	-
2 DOC	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	3.3 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	12 months
response rate (RECIST)	3 months
Number of Participants with Adverse Events	4 months

Trial Locations

Locations (1)

32 Sites; 🇯🇵 Multiple Locations, Japan