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

Novartis

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: RAD001; Drug: erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456833

CRAD001C2111

2004-003017-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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248 participants in 2 patient groups

RAD 5mg/day + erlotinib

Experimental group

Treatment:

Drug: RAD001

erlotinib 150mg/day

Active Comparator group

Treatment:

Drug: erlotinib

Drug: RAD001