Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Amrubicin Hydrochloride; Drug: Etoposide-Cisplatin combined chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Shanghai, China
  • Tianjin, China
  • Fujian
    • Fuzhou, Fujian, China
  • Gansu
    • Lanzhou, Gansu, China
  • Guangdong
    • Guangzhou, Guangdong, China
  • Hunan
    • Changsha, Hunan, China
  • Jiangsu
    • Nanjing, Jiangsu, China
  • Jiangxi
    • Nanchang, Jiangxi, China
  • Jilin
    • Changchun, Jilin, China
  • Liaoning
    • Dalian/Shenyang, Liaoning, China
    • Shenyang, Liaoning, China
  • Shanxi
    • Xian, Shanxi, China
  • Sichuan
    • Chengdu, Sichuan, China
  • Zhejiang
    • Hangzhou, Zhejiang, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically/cytologically proven small cell lung cancer
• Extensive disease
• No prior chemotherapy regimen
• Age 18 years or older
• ECOG performance status of 0-1

Exclusion Criteria:

• Brain metastasis requiring treatment
• Treatment (Surgical or radiotherapy)of primary tumor
• Interstitial pneumonia or pulmonary fibrosis
• Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Amrubicin Hydrochloride-Cisplatin combined chemotherapy	Drug: Amrubicin Hydrochloride; Amrubicin Hydrochloride combined with cisplatin
Active Comparator: 2; Etoposide-Cisplatin combined chemotherapy	Drug: Etoposide-Cisplatin combined chemotherapy; combined chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	1.5 years after last subject enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival		1.5 years after last subject enrolled
Objective Response Rate	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	participants were followed for the duration of the study, an average of 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Overall Survival at 6 and 12 Months	6 and 12 months.

Collaborators and Investigators

• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Yan Sun, MD, Cancer Hospital, Chinese Academy of Medical Science

Publications and helpful links

General Publications

• Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): July 18, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Extensive Disease-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Amrubicin
• Other Study ID Numbers: D0750018