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: July 23, 2015
Last verified: July 2015

August 16, 2010
July 23, 2015
October 2010
October 2013   (final data collection date for primary outcome measure)
  • Progression-Free Survival (PFS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
  • Progression-Free Survival (PFS) at the End of Study [ Time Frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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 ]
Complete list of historical versions of study NCT01183858 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ] [ Designated as safety issue: No ]
    OS defined as the time from randomization to the date of death due to any cause.
  • Overall Response Rate (ORR) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
  • Disease Control Rate (DCR) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
  • Time to Progression (TTP) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
  • Number of Participants With Adverse Events (AEs) at the End of the Study [ Time Frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) ] [ Designated as safety issue: No ]

    An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

    A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.

  • Overall Survival (OS) at the End of Study [ Time Frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months) ] [ Designated as safety issue: No ]
    OS defined as the time from randomization to the date of death due to any cause.
  • 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 ]
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 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.
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]
Single daily oral dose
Other Name: Tarceva
  • Experimental: Erlotinib 150 mg
    Erlotinib 150 mg single daily oral dose until disease progression.
    Intervention: Drug: Erlotinib [Tarceva]
  • Experimental: Erlotinib 300 mg
    Erlotinib 300 mg single daily oral dose until disease progression.
    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
October 2013   (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
  • 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 Criteria:

  • 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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Denmark,   Egypt,   France,   Germany,   Netherlands,   Spain,   Switzerland,   Turkey
Portugal,   United States
 
NCT01183858
MO22162, 2010-018476-24
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2015

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