Clinical trial · Interventional
Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer
A Randomized Phase II Trial of Irinotecan Plus Lobaplatin Versus Irinotecan for the Second-line Treatment of Relapsed Small-cell Lung Cancer
NCT03613753CI-TRIAL-00043202unknownPhase 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)
This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent 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 |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
| irinotecan plus lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Chemotherapy:irinotecan plus lobaplatin
- interventionNames
- Drug: irinotecan plus lobaplatin
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Chemotherapy:irinotecan
- interventionNames
- Drug: irinotecan
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- >4 weeks post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed SCLC * Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC * At least 30 days after the completion of first-line chemotherapy * Either sex, age between 18 to 70 years * Expected life time ≥ 3 months * Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded. * Adequate bone marrow and organ function as defined below: Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L * Had measurable or assessable disease Exclusion Criteria: * Concomitant with other malignant disease * Pregnancy or lactation at the time of enrollment * Any contraindications for chemotherapy * Received target therapy or immunotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.