Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Small-Cell Lung Cancer

Intervention / Treatment
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* Drug: Everolimus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily dosing RAD001<br> | Drug: Everolimus<br>* RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.<br>* Other names: RAD001;|
| Experimental: Weekly dosing RAD001<br> | Drug: Everolimus<br>* RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.<br>* Other names: RAD001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1 |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen |  | within 6 cycles (Day 126) | 
| PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles |  | During the first 6 cycles | 
| Overall tumor response |  | Every 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide