Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer. Eligible patients, for whom the treating physician has decided to initiate treatment with Tarceva according to the local label will be followed for 18 months.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer * Patients for whom the treating physician has decided to initiate first-line therapy with Tarceva in accordance with the Summary of Product Characteristics and local guidelines
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 18 months | 3.5 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with remission | 3.5 years |
| Progression-free survival (overall/stratified) | 3.5 years |
| Overall survival (overall/stratified) | 3.5 years |
| Response rate (complete response/partial response) by type of mutation | 3.5 years |
| Safety: Incidence of serious adverse events | 3.5 years |
| Dose modifications/withdrawals | 3.5 years |
| Symptom control (cough, dyspnea) | 3.5 years |
| Tolerability: Incidence of fatigue, rash, diarrhea | 3.5 years |
Countries
Germany
Outcome results
None listed