A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC) (MERIT)
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| ClinicalTrials.gov Identifier: NCT02774278 |
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Recruitment Status :
Completed
First Posted : May 17, 2016
Results First Posted : August 2, 2016
Last Update Posted : August 8, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Drug: Erlotinib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 264 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients |
| Study Start Date : | July 2005 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Erlotinib
Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
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Drug: Erlotinib
Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
Other Name: Tarceva |
Primary Outcome Measures :
- 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.
- 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.
- 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.
Secondary Outcome Measures :
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774278
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, 197089 | |
| St Petersburg, Russian Federation, 197758 | |
| St Petersburg, Russian Federation, 198255 | |
| Singapore | |
| Singapore, Singapore, 169610 | |
| Spain | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08916 | |
| Madrid, Spain, 28041 | |
| Taiwan | |
| Taipei, Taiwan, 00112 | |
| Taipei, Taiwan, 105 | |
| Taipei, Taiwan, 106 | |
| United Kingdom | |
| Weston Super Mare, United Kingdom, BS23 4TQ | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Chair: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT02774278 |
| Other Study ID Numbers: |
BO18279 2004-005096-42 ( EudraCT Number ) |
| First Posted: | May 17, 2016 Key Record Dates |
| Results First Posted: | August 2, 2016 |
| Last Update Posted: | August 8, 2016 |
| Last Verified: | August 2016 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |