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

NCT ID: NCT00456833

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Keywords

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Non Small Cell Lung Cancer NSCLC Advanced lung cancer RAD RAD001 erlotinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAD 5mg/day + erlotinib

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

erlotinib 150mg/day

Group Type ACTIVE_COMPARATOR

RAD001

Intervention Type DRUG

erlotinib

Intervention Type DRUG

Interventions

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RAD001

Intervention Type DRUG

erlotinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Atlanta, Georgia, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Rochester, Minnesota, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Madison, Wisconsin, United States

Site Status

Novartis Investigative Site

Richmond, British Columbia, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Herlev, , Denmark

Site Status

Novartis Investigative Site

Saint-Herblain Cédex, , France

Site Status

Novartis Investigative Site

Villejuif, , France

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Countries

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United States Canada Denmark France Russia

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5703

Results for CRAD001C2111 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2004-003017-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001C2111

Identifier Type: -

Identifier Source: org_study_id