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An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (TIME)

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ClinicalTrials.gov Identifier: NCT01664533
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : December 28, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date August 10, 2012
First Posted Date August 14, 2012
Results First Submitted Date October 9, 2015
Results First Posted Date December 28, 2015
Last Update Posted Date December 28, 2015
Study Start Date September 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2015)
Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years) ]
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease 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 of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Original Primary Outcome Measures
 (submitted: August 10, 2012)
Progression-free Survival [ Time Frame: approximately 3 years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 23, 2015)
  • Best Overall Response [ Time Frame: Baseline to the end of the study (up to 2 years) ]
    Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
  • Overall Survival [ Time Frame: Up to 2 years ]
    Overall survival was defined as the time from Baseline until death from any cause.
  • Percentage of Participants Who Developed Rash [ Time Frame: Up to 2 years ]
  • Percentage of Participants Who Developed Diarrhea [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures
 (submitted: August 10, 2012)
  • Best overall response (tumor assessments according to RECIST or other criteria) [ Time Frame: approximately 3 years ]
  • Best confirmed overall response [ Time Frame: approximately 3 years ]
  • Response rate [ Time Frame: approximately 3 years ]
  • Disease control rate [ Time Frame: approximately 3 years ]
  • Overall Survival [ Time Frame: approximately 3 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy
Official Title Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
Brief Summary This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.
Condition Non-Squamous Non-Small Cell Lung Cancer
Intervention Drug: Erlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Other Name: Tarceva
Study Groups/Cohorts Erlotinib
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Intervention: Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 23, 2015)
57
Original Estimated Enrollment
 (submitted: August 10, 2012)
250
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
  • Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).

Exclusion Criteria:

  • Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
  • Contraindication for Tarceva according to the Summary of Product characteristics.
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01664533
Other Study ID Numbers ML25708
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2015