Clinical trial · Interventional
Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin for Patients With Limited Small-cell Lung Cancer
A Randomized Phase II Trial of Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin in Combination With Concurrent Thoracic Radiotherapy for Patients With Limited Small-cell Lung Cancer
NCT03613597CI-TRIAL-00043170unknownPhase 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 (etoposide plus lobaplatin or etoposide plus cisplatin) in combination with concurrent thoracic radiation therapy (TRT) for limited 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 |
|---|---|---|---|
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etoposide plus cisplatin | Drug | — | UNRESOLVED |
| etoposide plus lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Etoposide plus Lobaplatin group
- description
- Chemotherapy:etoposide plus lobaplatin (EL)
- interventionNames
- Drug: etoposide plus lobaplatin
- type
- ACTIVE_COMPARATOR
- label
- Etoposide plus Cisplatin group
- description
- Chemotherapy:etoposide plus cisplatin (EP)
- interventionNames
- Drug: etoposide plus cisplatin
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed SCLC * Newly diagnosed SCLC * Either sex, age between 18 to 75 years * Limited stage: AJCC (8th edition) Stage I-III (T any, N any, M0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. * 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, liver and renal 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, and creatinine concentration ≤120 μmol/L * No history of thoracic surgery, radiation therapy, or chemotherapy * Had measurable or assessable disease Exclusion Criteria: * Pregnancy or lactation at the time of enrollment * Previous malignancy or other concomitant malignant disease * Malignant pleural or pericardial effusions
References
Publications (1)
- DERIVEDWang M, Ma Z, Li Q, Yang W, Chen X, Geng Y, Luo D, Hu Y, Wu B, Jiang W, Su S, Ouyang W, Lu B. Preliminary results of randomized phase II study of etoposide plus lobaplatin or etoposide plus cisplatin with concurrent thoracic radiotherapy in the treatment of limited-stage small cell lung cancer. Anticancer Drugs. 2023 Nov 1;34(10):1183-1189. doi: 10.1097/CAD.0000000000001501. Epub 2023 Jan 24. PMID 36727741