A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01183858

First received: August 16, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 16, 2010

Last Updated Date

May 7, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare the efficacy of two dose levels of Tarceva on progression-free survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01183858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the efficacy of 150 mg versus 300 mg Tarceva with respect to response and disease control rates, and overall survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
To assess the safety of Tarceva [ Time Frame: Throughout study (up to 3 years) ] [ Designated as safety issue: No ]
To evaluate the plasma concentrations of Tarceva [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
To assess the quality of life [ Time Frame: Questionnaire every 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

Official Title ^ICMJE

A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

Brief Summary

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Non-Small Cell Lung Cancer

Intervention ^ICMJE

Drug: Erlotinib [Tarceva]
150 mg single daily oral dose until disease progression
Drug: Erlotinib [Tarceva]
300 mg single daily oral dose until disease progression

Study Arm (s)

Experimental: 1
Intervention: Drug: Erlotinib [Tarceva]
Experimental: 2
Intervention: Drug: Erlotinib [Tarceva]

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients aged >/=18 years
inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
ECOG performance status 0-2
Life expectancy >/=12 weeks
Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average >/=1 cigarette per day), not intending to stop during the study

Exclusion Criteria:

Prior antibody or small molecule therapy against EGFR
Radiotherapy within 28 days prior to enrolment
Received more than one line of chemotherapy for locally advanced/metastatic NSCLC

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: MO22162 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

United States, China, Denmark, Egypt, France, Germany, Netherlands, Spain, Switzerland, Turkey

Administrative Information

NCT Number ^ICMJE

NCT01183858

Other Study ID Numbers ^ICMJE

MO22162, 2010-018476-24

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top