Clinical Trial Protocol Registry
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
- Protocol number:
- Hoffmann-La Roche
- Company division:
- Official Scientific Title:
- STUDY OF TARCEVATM (ERLOTINIB) IN PATIENTS WITH ADVANCED STAGE NON-SMALL- CELL LUNG CANCER IN FIRST OR SECOND LINE THERAPY
- 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. Target sample size is 5.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study
- Non-Small Cell Lung Cancer
- Primary outcome:
- Incidence of adverse events (AEs) Time frame: Length of patient on study (length of time of patient on study determined by investigator)
- Key secondary outcomes:
- Best Response Rate per investigator assessment Time frame: Length of patient on study (length of time of patient on study determined by investigator)
- Time to Progression (TTP) Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
- Overall survival Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
- 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A N/A
- Accepts healthy volunteers:
- Anticipated start date:
- June, 2009
- Trial registration date:
- Date last updated:
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