A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC) (MERIT)

August 5, 2016 updated by: Hoffmann-La Roche

MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients

This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

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

  • Belgium
      • Bruxelles, Belgium, B-1200
  • Bulgaria
      • Sofia, Bulgaria, 1756
  • Estonia
      • Tallin, Estonia, 11619
      • Tartu, Estonia, 51014
  • France
      • Montpellier, France, 34295
      • Paris, France, 75970
  • Germany
      • Grosshansdorf, Germany, 22927
      • Köln, Germany, 50937
  • Hong Kong
      • Hong Kong, Hong Kong
  • Ireland
      • Dublin, Ireland, 8
  • Italy
      • Perugia, Italy, 06132
  • Poland
      • Gdansk, Poland, 80-214
      • Lodz, Poland, 94-306
      • Lublin, Poland, 20-950
      • Poznan, Poland, 60-569
  • Russian Federation
      • Moscow, Russian Federation, 105229
      • Moscow, Russian Federation, 107005
      • Moscow, Russian Federation, 115478
      • St Petersburg, Russian Federation, 197758
      • St Petersburg, Russian Federation, 198255
      • St Petersburg, Russian Federation, 197089
  • Singapore
      • Singapore, Singapore, 169610
  • Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08916
      • Madrid, Spain, 28041
  • Taiwan
      • Taipei, Taiwan, 00112
      • Taipei, Taiwan, 106
      • Taipei, Taiwan, 105
  • United Kingdom
      • Weston Super Mare, United Kingdom, BS23 4TQ

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:

  • Advanced NSCLC
  • Tumor accessible for biopsy by bronchoscopy
  • Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion Criteria:

  • Unstable systemic disease
  • Any other malignancies in the last 5 years
  • Brain metastases
  • Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erlotinib
Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
Drug: Erlotinib
Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Differentially Expressed Genes Associated With Clinical Benefit
Time Frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.
Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit
Time Frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Number of KRAS Mutation Participants Who Achieved Clinical Benefit
Time Frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.
Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST
Time Frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.
Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years

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

July 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO18279
  • 2004-005096-42 (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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