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Trial record 2 of 2 for:    pepita

PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01659970
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date August 6, 2012
First Posted Date August 8, 2012
Last Update Posted Date November 2, 2016
Study Start Date June 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2012)
Progression-free survival [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 6, 2012)
  • Clinical/demographic patients characteristics at baseline [ Time Frame: 2 years ]
  • Treatment schedules: Dose/duration/modifications/interruptions [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
  • Safety: Incidence of adverse events [ Time Frame: 2 years ]
  • Quality of life: FACT-L version 4 questionnaire [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Official Title A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Brief Summary This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.
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 squamous NSCLC initiating 2nd line treatment with Tarceva
Condition Non-Squamous Non-Small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Cohort
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: March 3, 2014)
152
Original Estimated Enrollment
 (submitted: August 6, 2012)
151
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy
  • Patients for whom the treating physician has decided to initiate treatment with Tarceva

Exclusion Criteria:

  • Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component
  • Current participation in a clinical trial evaluating an anticancer treatment
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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01659970
Other Study ID Numbers ML28195
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 2016