Lung cancer
Conditions
Interventions
erlotinib 1500 mg once every week
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Histologically confirmed stage IV non-squamous NSCLC patients. * Patients with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy in daily dose of 150 mg or 250 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible). * Tumor biopsy available for EGFR mutation analysis at progression * At least one measurable disease site, according to RECIST 1.1 criteria. * WHO performance status 0-2. * Willing and able to comply with the study prescriptions * 18 years or older. * Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study. * Ability to give and having given written informed consent before patient registration.
Exclusion criteria
Exclusion criteria: Uncontrolled infectious disease. Other active malignancy. Major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks. Treatment with investigational drugs. Known prior hypersensitivity to erlotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the disease control rate (DCR) at 8 weeks according to the response evaluation criteria in solid tumors (RECIST v1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess progression-free survival (PFS) - To assess toxicity of high-dose erlotinib according to CTC AE 4.0. | — |
Countries
Netherlands
Outcome results
None listed