A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

June 9, 2014 updated by: Hoffmann-La Roche

An Open-label Study of the Effect of Tarceva Monotherapy on Treatment Response in Patients With Advanced Non-small Cell Lung Cancer for Whom Tarceva Monotherapy is Considered the Best Option

This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1805

Phase

  • Phase 2

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

  • Spain
      • Alicante, Spain, 3010
      • Avila, Spain, 05071
      • Badajoz, Spain, 06080
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08916
      • Barcelona, Spain, 08029
      • Barcelona, Spain, 08227
      • Barcelona, Spain, 08022
      • Barcelona, Spain, 08017
      • Burgos, Spain, 09006
      • Caceres, Spain, 10003
      • Castellon, Spain, 12002
      • Cordoba, Spain, 14004
      • Girona, Spain, 17007
      • Granada, Spain, 18014
      • Granada, Spain, 18003
      • Huelva, Spain, 21005
      • Jaen, Spain, 23007
      • La Coruña, Spain, 15006
      • Leon, Spain, 24071
      • Lerida, Spain, 25198
      • Lugo, Spain, 27004
      • Madrid, Spain, 28006
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28222
      • Madrid, Spain, 28033
      • Madrid, Spain, 28002
      • Madrid, Spain, 28935
      • Madrid, Spain, 28660
      • Malaga, Spain, 29010
      • Murcia, Spain, 30120
      • Murcia, Spain, 30008
      • Navarra, Spain, 31008
      • Orense, Spain, 32005
      • Palencia, Spain, 34005
      • Salamanca, Spain, 37007
      • Segovia, Spain, 40002
      • Sevilla, Spain, 41014
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41009
      • Valencia, Spain, 46017
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Valencia, Spain, 46009
      • Valencia, Spain, 41014
      • Valencia, Spain, 46015
      • Valladolid, Spain, 47010
      • Zaragoza, Spain, 50009
    • Alicante
      • Alcoy, Alicante, Spain, 03804
      • Elche, Alicante, Spain, 03203
    • Almeria
      • Almería, Almeria, Spain, 04009
    • Badajoz
      • Don Benito, Badajoz, Spain, 06400
      • Merida, Badajoz, Spain, 06800
    • Barcelona
      • Badalona, Barcelona, Spain, 08911
      • Granollers, Barcelona, Spain, 08400
      • Manresa, Barcelona, Spain, 08243
      • Mataro, Barcelona, Spain, 08304
      • Sabadell, Barcelona, Barcelona, Spain, 08208
      • Sant Coloma Gramenet, Barcelona, Spain, 08923
      • Sant Pere de Ribes, Barcelona, Spain, 08810
      • Terrassa, Barcelona, Spain, 08221
      • VIC, Barcelona, Spain, 08500
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
      • Cádiz, Cadiz, Spain, 11009
      • Jerez de La Frontera, Cadiz, Spain, 11407
      • Puerto Real, Cadiz, Spain, 11510
    • Cantabria
      • Santander, Cantabria, Spain, 39008
      • Torrevieja, Cantabria, Spain, 03180
    • Granada
      • Baza, Granada, Spain, 18800
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
    • Islas Baleares
      • Ibiza, Islas Baleares, Spain, 07800
      • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Palma de Mallorca, Islas Baleares, Spain, 07012
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
      • La Coruna, La Coruña, Spain, 15009
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
    • Murcia
      • Cartagena, Murcia, Spain, 30203
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
      • Vigo, Pontevedra, Spain, 36211
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
    • Valencia
      • Sagunto, Valencia, Spain, 46520
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
      • Bilbao, Vizcaya, Spain, 48013

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients >=18 years of age;
  • locally advanced or metastatic NSCLC (Stage IIIB or IV);
  • not a candidate for curative surgery or radical chemotherapy;
  • no brain metastases, or clinically stable metastases for >=2 months.

Exclusion Criteria:

  • radiotherapy over the previous 2 weeks;
  • weight loss >10% in the previous 6 weeks.

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: Tarceva Arm
Drug: erlotinib [Tarceva]
150 mg/day until progressive disease or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Disease Progression or Death by Line of Treatment
Time Frame: Baseline, every 6-8 weeks up to 3 years until disease progression or death
Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.
Baseline, every 6-8 weeks up to 3 years until disease progression or death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Benefit by Line of Treatment
Time Frame: Baseline, every 6-8 weeks up to 3 years or until death
Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.
Baseline, every 6-8 weeks up to 3 years or until death
Overall Survival (OS) by Line of Treatment
Time Frame: Baseline, every 6-8 weeks up to 3 years, or until death
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).
Baseline, every 6-8 weeks up to 3 years, or until death

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

April 1, 2004

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17915

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.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on erlotinib [Tarceva]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe