MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 264
- Primary Endpoint
- Number of Differentially Expressed Genes Associated With Clinical Benefit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Erlotinib
Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
Intervention: Erlotinib (Drug)
Outcomes
Primary Outcomes
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 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.
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.
Secondary Outcomes
- Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST(Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years)
- Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)(Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years)