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)

• ClinicalTrials.gov Identifier: NCT01183858
• Recruitment Status: Completed
• First Posted: August 18, 2010
• Results First Posted: February 23, 2015
• Last Update Posted: August 19, 2015
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: August 16, 2010
• First Posted Date: August 18, 2010
• Results First Submitted Date: February 5, 2015
• Results First Posted Date: February 23, 2015
• Last Update Posted Date: August 19, 2015
• Study Start Date: October 2010
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2015)

• Progression-Free Survival (PFS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) ]
  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) ]
  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.

• Original Primary Outcome Measures (submitted: August 16, 2010): To compare the efficacy of two dose levels of Tarceva on progression-free survival [ Time Frame: Tumor assessments every 6 weeks ]

Current Secondary Outcome Measures (submitted: July 23, 2015)

• Overall Survival (OS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months) ]
  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) ]
  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) ]
  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) ]
  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) ]
  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) ]
  OS defined as the time from randomization to the date of death due to any cause.

Original Secondary Outcome Measures (submitted: August 16, 2010)

• 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 ]
• To assess the safety of Tarceva [ Time Frame: Throughout study (up to 3 years) ]
• To evaluate the plasma concentrations of Tarceva [ Time Frame: Every 6 weeks ]
• To assess the quality of life [ Time Frame: Questionnaire every 6 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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)
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Non-Small Cell Lung Cancer

Intervention

Drug: Erlotinib [Tarceva]

Single daily oral dose

Other Name: Tarceva

Study Arms

• 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]

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2013): 315
• Original Estimated Enrollment (submitted: August 16, 2010): 300
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Denmark, Egypt, France, Germany, Netherlands, Spain, Switzerland, Turkey
• Removed Location Countries: Portugal, United States

Administrative Information

• NCT Number: NCT01183858
• Other Study ID Numbers: MO22162; 2010-018476-24 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Disclosures Group, Hoffmann-La Roche
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: July 2015