Clinical trial · Interventional
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer
NCT01497873CI-TRIAL-00036280completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belotecan | Drug | — | UNRESOLVED |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Belotecan
- description
- Camtobell Injection
- interventionNames
- Drug: Belotecan
- type
- ACTIVE_COMPARATOR
- label
- Topotecan
- description
- Hycamtin Injection
- interventionNames
- Drug: Topotecan
Primary outcomes (1)
- measure
- Objectives Response Rate(ORR, %)
- timeFrame
- Up to 18weeks
- description
- The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Histological or cytological diagnosis of SCLC * Limited disease (LD) or Extensive disease (ED) at time of study entry * Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy * Measurable disease defined by RECIST criteria * ECOG Performance Status of 0, 1, or 2 * Life expectancy ≥ 3 months * Adequate bone marrow, Renal, Hepatic reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance \> 60mL/min \- Signed a written informed consent Exclusion Criteria: * Active infection * Symptomatic brain lesion * Any other type of cancer during the previous 5 years * Severe concurrent diseases * Prior anticancer therapy within 4 weeks before enroll * Active pregnancy test and Pregnant or nursing women * Participation in any investigational drug study within 28 days prior to study entry
References
Publications (1)
- DERIVEDKang JH, Lee KH, Kim DW, Kim SW, Kim HR, Kim JH, Choi JH, An HJ, Kim JS, Jang JS, Kim BS, Kim HT. A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. Br J Cancer. 2021 Feb;124(4):713-720. doi: 10.1038/s41416-020-01055-5. Epub 2020 Nov 16. PMID 33191408