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: February 5, 2015
Last verified: February 2015
  Purpose

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.


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:
  • Progression-Free Survival (PFS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 68.7 Weeks) ] [ 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.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 68.7 Weeks) ] [ 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 68.7 Weeks) ] [ 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 68.7 Weeks) ] [ 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 68.7 Weeks) ] [ 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 Final Database Lock: 05 March 2014 (Up to 32.4 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.



Enrollment: 315
Study Start Date: September 2010
Study Completion Date: February 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
Drug: Erlotinib [Tarceva]
Single daily oral dose
Other Name: Tarceva
Experimental: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
Drug: Erlotinib [Tarceva]
Single daily oral dose
Other Name: Tarceva

  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
  • 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)
  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
Results First Received: February 5, 2015
Last Updated: February 5, 2015
Health Authority: Spain: Agencia Española del Medicamento y Productos sanitarios (AEMPS)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
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 March 26, 2015