Phase 4
Completed N=24
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
Source: ClinicalTrials.gov NCT01287754 ↗Enrolled (actual)
24
Serious AEs
33.3%
Results posted
Jun 2015
Primary outcomePrimary: Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation — 13.7 months
Summary
This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation |
13.7 | — |
| SECONDARY Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1 |
2; 1 | — |
| SECONDARY Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants |
17.8; 11.3 | — |
| SECONDARY Percentage of Participants Alive at 6 and 12 Months |
100; 67; 100; 24 | — |
| SECONDARY Percentage of Participants With EGFR Mutation at Screening |
17 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
- Measurable disease according to RECIST criteria
- ECOG performance status 0-2
- Adequate haematological, renal and liver function
Exclusion Criteria
- Previous chemotherapy or therapy against EGFR for metastatic disease
- History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
- Symptomatic cerebral metastases
- Pre-existing parenchymal lung disease such as pulmonary fibrosis
- Concomitant use of coumarins
Data sourced from ClinicalTrials.gov (NCT01287754). 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.