Status:
COMPLETED
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (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
- Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
- Radiotherapy within 28 days prior to enrollment
- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT01183858
Start Date
October 1 2010
End Date
February 1 2014
Last Update
August 19 2015
Active Locations (63)
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1
Beijing, China, 100071
2
Changchun, China, 130012
3
Chengdu, China, 610041
4
Fuzhou, China, 350014