Clinical trial · Interventional
Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy
A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy
NCT00456833CI-TRIAL-00049030completedPhase 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 assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib | Drug | Erlotinib | ALIAS |
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RAD 5mg/day + erlotinib
- interventionNames
- Drug: RAD001
- type
- ACTIVE_COMPARATOR
- label
- erlotinib 150mg/day
- interventionNames
- Drug: RAD001
- Drug: erlotinib
Primary outcomes (2)
- measure
- Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
- timeFrame
- first 28 days of combined treatment
- measure
- Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * Age over 18 years * Advanced Non Small Cell Lung Cancer which is not responding to chemotherapy treatment including either cisplatin or carboplatin * Only 1-2 previous chemotherapy regimens for advanced disease * More than 2 weeks from previous surgery, radiation or chemotherapy * Ability to perform normal daily functions Exclusion criteria: * Chronic steroid treatment * Prior treatment with EGFR inhibitors * Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions or other severe medical conditions * Other cancers within the past 2 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.