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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1805

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tarceva Arm
Drug: erlotinib [Tarceva]
150 mg/day until progressive disease or unacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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