Phase 2
Completed N=30
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Source: ClinicalTrials.gov NCT01260181 ↗Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Oct 2018
Primary outcomePrimary: Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 — 63.3 percentage of participants
Summary
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 |
63.3 | — |
| SECONDARY Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 |
40 | — |
| SECONDARY Overall Survival |
83 | — |
| SECONDARY Percentage of Participants With Adverse Events |
29 | — |
| SECONDARY Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population |
40; 60 | — |
| SECONDARY Median Time Taken From the First Response Until Disease Progression Based on RECIST v 1.1 as Determined by the Investigator |
41.5 | — |
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic NSCLC with EGFR mutations
- Measurable disease according to RECIST criteria
- Adequate hematological, renal and liver function
Exclusion Criteria
- Previous chemotherapy or therapy against EGFR for metastatic disease
- Symptomatic cerebral metastases
- Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
- History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- Concomitant use of coumarins
Data sourced from ClinicalTrials.gov (NCT01260181). 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.