Clinical trial · Interventional
Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
NCT02943798CI-TRIAL-00024418unknownPhase 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 primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.
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 |
|---|---|---|---|
| Pulmonary Large Cell Neuroendocrine Carcinoma | Lung Large Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etoposide plus carboplatin | Drug | — | UNRESOLVED |
| Paclitaxel plus carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Patients will be administered with etoposide plus carboplatin as first-line treatment.
- interventionNames
- Drug: etoposide plus carboplatin
- type
- EXPERIMENTAL
- label
- Group B
- description
- Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
- interventionNames
- Drug: Paclitaxel plus carboplatin
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology * Estimated life expectancy over 3 months * Performance status 0,1,2 * Signed informed consent * Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine \< 2.5 mg/dL (221 mmol/L); serum AST or ALT \<5.0 x upper limit of normal (ULN); serum total bilirubin \<2.0 mg/dL (34 mmol/L) Exclusion Criteria: * History of chemotherapy or molecular targeted therapy * Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy * Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy * Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Pregnant or lactating * Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
References
Publications (1)
- RESULTFasano M, Della Corte CM, Papaccio F, Ciardiello F, Morgillo F. Pulmonary Large-Cell Neuroendocrine Carcinoma: From Epidemiology to Therapy. J Thorac Oncol. 2015 Aug;10(8):1133-41. doi: 10.1097/JTO.0000000000000589. PMID 26039012