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

Novartis

Status and phase: Completed; Phase 1

Conditions: Small-Cell Lung Cancer

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00466466

CRAD001C2116

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Daily dosing RAD001

Experimental group

Treatment:

Drug: Everolimus

Weekly dosing RAD001

Experimental group

Treatment:

Drug: Everolimus