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)
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To compare the efficacy of two dose levels of Tarceva on progression-free survival
Outcome Time Frame:
Tumor assessments every 6 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)
Study ID:
MO22162
NCT ID:
NCT01183858
Start Date:
October 2010
Completion Date:
December 2014
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Omaha, Nebraska 68114 |
