Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Interventions
DRUGerlotinib [Tarceva]
150mg po daily
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>= 18 years of age; * inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer; * ECOG performance status of 0-3; * previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.
Exclusion criteria
* prior systemic anti-tumor therapy with HER1/EGFR inhibitors; * unstable systemic disease; * any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer; * any significant ophthalmologic abnormality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Length of patient on study (length of time of patient on study determined by investigator) |
Secondary
| Measure | Time frame |
|---|---|
| Best Response Rate per investigator assessment | Length of patient on study (length of time of patient on study determined by investigator) |
| Time to Progression (TTP) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
| Overall survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first |
Countries
Russia
Outcome results
None listed