Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient (COMBAT)

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Belotecan (Camtobell, CKD-602, Chong Kun Dang Pharm., Korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase I. The investigators will have a randomized prospective multicenter trial of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer.

Primary endpoints

• to assess Response Rate

Secondary endpoints

• to assess Overall response duration, Time to progression, Overall survival

Study Overview

• Status: Completed
• Conditions: Carcinoma, Small Cell
• Intervention / Treatment: Drug: Belotecan; Drug: Cisplatin; Drug: Etoposide

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hwasun, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ECOG Performance status 0~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks)
• Histologically or cytologically confirmed small cell lung cancer Patient without chemotherapy and radiotherapy
• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
• Life expectancy of at least 3 months
• Provision of written informed consent

Exclusion Criteria:

• As judged by the investigator, any evidence of severe or uncontrolled systemic disease
• Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)
• Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of liver metastases)
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
• Pregnancy or breast-feeding women(women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
• Evidence of brain metastasis

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: Belotecan plus Cisplatin	Drug: Belotecan; Belotecan : 0.5mg/㎡/day for Day 1 to 4, repeated every 3 weeks; Other Names: Camtobell; Drug: Cisplatin; Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks
Active Comparator: Etoposide plus Cisplatin	Drug: Cisplatin; Cisplatin 60mg/㎡/day for Day 1, repeated every 3 weeks; Drug: Etoposide; Etoposide 100mg/㎡/day for Day 1 to 3, repeated every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
to assess the overall response duration	two years
To assess the time to progression	two years
to assess the overall survival	two years

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: In-Jae Oh, M.D.,Ph.D., Chonnam National University Hospital

Publications and helpful links

General Publications

• Oh IJ, Kim KS, Park CK, Kim YC, Lee KH, Jeong JH, Kim SY, Lee JE, Shin KC, Jang TW, Lee HK, Lee KY, Lee SY. Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial. BMC Cancer. 2016 Aug 26;16(1):690. doi: 10.1186/s12885-016-2741-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Small cell lung cancer; Camptothecin; Response rate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Etoposide; Cisplatin; Belotecan
• Other Study ID Numbers: CSCLC-0810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No