Phase 4
Completed N=62
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Source: ClinicalTrials.gov NCT01609543 ↗Enrolled (actual)
62
Serious AEs
41.9%
Results posted
Feb 2016
Primary outcomePrimary: Progression-Free Survival (PFS) — 12.846 Months
Summary
This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
12.846 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) |
1.8; 64.3; 32.1; 1.8 | — |
| SECONDARY Percentage of Participants Who Were Alive at 1 Year |
82.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
- Non-small cell lung cancer with an EGFR activating mutation
- Patients must have evidence of disease, but measurable disease is not mandatory
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal and liver function
Exclusion Criteria
- Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
- Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
- Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
- Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
- Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
- Pregnant or breast-feeding women
Data sourced from ClinicalTrials.gov (NCT01609543). 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.