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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
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Erlotinib [Tarceva]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 315
Study Start Date: September 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Erlotinib [Tarceva]
150 mg single daily oral dose until disease progression
Experimental: 2 Drug: Erlotinib [Tarceva]
300 mg single daily oral dose until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183858

  Show 63 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01183858     History of Changes
Other Study ID Numbers: MO22162, 2010-018476-24
Study First Received: August 16, 2010
Last Updated: November 10, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014