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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cisplatin; Etoposide; Etoposide phosphate; Everolimus; Sirolimus

Criteria

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.