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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183858
First received: August 16, 2010
Last updated: November 10, 2014
Last verified: November 2014

August 16, 2010
November 10, 2014
September 2010
February 2014   (final data collection date for primary outcome measure)
To compare the efficacy of two dose levels of Tarceva on progression-free survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01183858 on ClinicalTrials.gov Archive Site
  • To evaluate the efficacy of 150 mg versus 300 mg Tarceva with respect to response and disease control rates, and overall survival [ Time Frame: Tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • To assess the safety of Tarceva [ Time Frame: Throughout study (up to 3 years) ] [ Designated as safety issue: No ]
  • To evaluate the plasma concentrations of Tarceva [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To assess the quality of life [ Time Frame: Questionnaire every 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)
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 ef ficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, r esponse and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line pl atinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 15 0 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: Erlotinib [Tarceva]
    150 mg single daily oral dose until disease progression
  • Drug: Erlotinib [Tarceva]
    300 mg single daily oral dose until disease progression
  • Experimental: 1
    Intervention: Drug: Erlotinib [Tarceva]
  • Experimental: 2
    Intervention: Drug: Erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
February 2014
February 2014   (final data collection date for primary outcome measure)

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 (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Denmark,   Egypt,   France,   Germany,   Netherlands,   Spain,   Switzerland,   Turkey
 
NCT01183858
MO22162, 2010-018476-24
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP