Clinical trial · Interventional
Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy
NCT00466466CI-TRIAL-00049068completedPhase 1ClinicalTrials.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 study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Daily dosing RAD001
- interventionNames
- Drug: Everolimus
- type
- EXPERIMENTAL
- label
- Weekly dosing RAD001
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1
- timeFrame
- Day 21
Secondary outcomes (3)
- measure
- Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC) * Age ≥ 18 years * WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions) * Adequate bone marrow, liver and renal function Exclusion criteria: * Chronic steroid treatment * Prior treatment with chemotherapy for advanced lung cancer * Prior treatment with mTOR inhibitors * Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions * Symptomatic or uncontrolled brain metastases * Other cancers within the past 5 years * Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.