Combination of RAD001 and Erlotinib in Patients With Advanced Non Small Cell Lung Cancer Previously Treated Only With Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: RAD001
* Drug: erlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAD 5mg/day + erlotinib<br> | Drug: RAD001<br> <br> |
| Active Comparator: erlotinib 150mg/day<br> | Drug: RAD001<br> <br> Drug: erlotinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | first 28 days of combined treatment | 
| 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 |  | at baseline and after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression |  | at baseline, monthly until month 4 then q2months until progression | 
| Phase 2: Safety and steady state drug levels evaluated monthly |  | Monthly | 
| Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue |  | Dec 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, NSCLC, Advanced lung cancer, RAD, RAD001, erlotinib