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
|Condition or disease||Intervention/treatment|
|Non-Squamous Non-Small Cell Lung Cancer||Drug: Erlotinib|
|Study Type :||Observational|
|Actual Enrollment :||57 participants|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
Erlotinib was supplied as tablets in the retail product Tarceva.
Other Name: Tarceva
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664533
|Aalst, Belgium, 9300|
|Antwerpen, Belgium, 2020|
|Boussu, Belgium, 7360|
|Bruxelles, Belgium, 1200|
|Charleroi, Belgium, 6000|
|Dendermonde, Belgium, 9200|
|Duffel, Belgium, 2570|
|Edegem, Belgium, 2650|
|Frameries, Belgium, 7080|
|Genk, Belgium, 3600|
|Gilly, Belgium, 6060|
|Gosselies, Belgium, 6041|
|Liege, Belgium, 4000|
|Mons, Belgium, 7000|
|Montegnée, Belgium, 4420|
|Namur, Belgium, 5000|
|Ottignies, Belgium, 1340|
|Roeselare, Belgium, 8800|
|Sint Niklaas, Belgium, 9100|
|Tournai, Belgium, 7500|
|Turnhout, Belgium, 2300|
|Study Director:||Clinical Trials||Hoffmann-La Roche|