Clinical trial · Interventional
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients
NCT02774278CI-TRIAL-00023389MERITcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib
- description
- Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
- interventionNames
- Drug: Erlotinib
Primary outcomes (3)
- measure
- Number of Differentially Expressed Genes Associated With Clinical Benefit
- timeFrame
- Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.