Clinical trial · Interventional
Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
Phase II Study of Camtobell Inj.(Belotecan) in Combination With 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)
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| belotecan hydrochloride | Drug | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- belotecan and Cisplatin
- description
- belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
- interventionNames
- Drug: belotecan hydrochloride
- Drug: cisplatin
Primary outcomes (4)
- measure
- Response rate as assessed by RECIST criteria
- timeFrame
- 21days(1cycle)
- measure
- Overall survival
- timeFrame
- 21days(1cycle)
- measure
- Progression-free survival
- timeFrame
- 21days(1cycle)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed small cell lung cancer meeting the following criteria: * Extensive-stage disease * Previously untreated disease * At least one measurable disease * No brain or leptomeningeal metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 mg/dL * ALT and AST ≤ 2.0 times upper normal limit (ULN) (≤ 5.0 times ULN in the presence of liver metastasis) * Alkaline phosphatase ≤ 2.0 times ULN * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * No active infection requiring intravenous antibiotics * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer * No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * No other concurrent chemotherapy, radiotherapy, or immunotherapy
References
Publications (0)
Data not yet available