Phase 2
Completed N=264
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT02774278 ↗Enrolled (actual)
264
Serious AEs
24.9%
Results posted
Aug 2016
Primary outcomePrimary: Number of Differentially Expressed Genes Associated With Clinical Benefit — 0 genes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Differentially Expressed Genes Associated With Clinical Benefit |
— | — |
| PRIMARY Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit |
6 | — |
| PRIMARY Number of KRAS Mutation Participants Who Achieved Clinical Benefit |
4 | — |
| SECONDARY Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST) |
15.2 | — |
| SECONDARY Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST |
31.4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02774278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.