Clinical trial · Interventional
Trial of Belotecan/Cisplatin in Chemotherapy Naive Small Cell Lung Cancer Patient
A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Belotecan plus Cisplatin
- interventionNames
- Drug: Belotecan
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Etoposide plus Cisplatin
- interventionNames
- Drug: Etoposide
- Drug: Cisplatin
Primary outcomes (1)
- measure
- To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer
- timeFrame
- two years
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOh 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. PMID 27566413