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
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
1 other identifier
observational
57
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
December 28, 2015
CompletedDecember 28, 2015
November 1, 2015
1.9 years
August 10, 2012
October 9, 2015
November 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
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.
Baseline to the end of the study (up to 2 years)
Secondary Outcomes (4)
Best Overall Response
Baseline to the end of the study (up to 2 years)
Overall Survival
Up to 2 years
Percentage of Participants Who Developed Rash
Up to 2 years
Percentage of Participants Who Developed Diarrhea
Up to 2 years
Study Arms (1)
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.
Interventions
Erlotinib was supplied as tablets in the retail product Tarceva.
Eligibility Criteria
Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Unknown Facility
Aalst, 9300, Belgium
Unknown Facility
Antwerp, 2020, Belgium
Unknown Facility
Boussu, 7360, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Charleroi, 6000, Belgium
Unknown Facility
Dendermonde, 9200, Belgium
Unknown Facility
Duffel, 2570, Belgium
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Frameries, 7080, Belgium
Unknown Facility
Genk, 3600, Belgium
Unknown Facility
Gilly, 6060, Belgium
Unknown Facility
Gosselies, 6041, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Mons, 7000, Belgium
Unknown Facility
Montegnée, 4420, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Ottignies, 1340, Belgium
Unknown Facility
Roeselare, 8800, Belgium
Unknown Facility
Sint-Niklaas, 9100, Belgium
Unknown Facility
Tournai, 7500, Belgium
Unknown Facility
Turnhout, 2300, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
September 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
December 28, 2015
Results First Posted
December 28, 2015
Record last verified: 2015-11