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

Novartis Pharmaceuticals248 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

248

Conditions

Non Small Cell Lung Cancer

Interventions

RAD001DRUG

erlotinibDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

Novartis Investigative Site

Atlanta, Georgia, United States

Novartis Investigative Site

Chicago, Illinois, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: at baseline and after 8 weeks of treatment

Secondary Outcomes

Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression

Time frame: at baseline, monthly until month 4 then q2months until progression

Phase 2: Safety and steady state drug levels evaluated monthly

Time frame: Monthly

Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue

Time frame: Dec 2009

Data from ClinicalTrials.gov

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