A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | October 2010 |
| End Date: | December 2014 |
| Contact: | Please reference Study ID Number: MO22162 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | genentechclinicaltrials@druginfo.com |
| Phone: | 888-662-6728 (U.S. Only) |
A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
This prospective, double-blind, randomized study will evaluate the safety and efficacy of
two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease
control rates and overall survival in patients with advanced or metastatic non-small cell
lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must
be current smokers and not intending to stop smoking during the study. Patients will be
randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses.
Treatment will continue until disease progression.
Inclusion Criteria:
- Adult patients aged >/=18 years
- inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node
metastases or malignant pleural or pericardial effusion) or metastatic (stage IV)
non-small cell lung cancer (NSCLC)
- Disease must be characterized according to Response Evaluation Criteria in Solid
Tumors (RECIST) criteria
- Patients have received one prior platinum-based chemotherapy regimen for advanced
NSCLC, but must have recovered from any treatment-related toxicity
- ECOG performance status 0-2
- Life expectancy >/=12 weeks
- Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and
currently smoking on average >/=1 cigarette per day), not intending to stop during
the study
Exclusion Criteria:
- Prior antibody or small molecule therapy against EGFR
- Radiotherapy within 28 days prior to enrolment
- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC
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