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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)

NCT01183858 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2015-08-19

Study results available
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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 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.

Conditions

Interventions

DRUG

Erlotinib [Tarceva]

Single daily oral dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-10-31
Completion
2014-02-28

Countries

  • China
  • Denmark
  • Egypt
  • France
  • Germany
  • Netherlands
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183858 on ClinicalTrials.gov