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

December 17, 2020 updated by: Novartis Pharmaceuticals

A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Richmond, British Columbia, Canada, V7C 5L9
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
  • Denmark
      • Herlev, Denmark, DK-2730
        • Novartis Investigative Site
  • France
      • Saint-Herblain Cédex, France, 44805
        • Novartis Investigative Site
      • Villejuif Cedex, France, 94805
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novartis Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Novartis Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Novartis Investigative Site
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD 5mg/day + erlotinib
Drug: RAD001
Active Comparator: erlotinib 150mg/day
Drug: erlotinib
Drug: RAD001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
at baseline and after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at baseline, monthly until month 4 then q2months until progression
Phase 2: Safety and steady state drug levels evaluated monthly
Time Frame: Monthly
Monthly
Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue
Time Frame: Dec 2009
Dec 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C2111
  • 2004-003017-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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