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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Non-Squamous Non-Small Cell Lung Cancer
Intervention Drug: Erlotinib
Enrollment 57
Recruitment Details Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.
Pre-assignment Details  
Arm/Group Title Erlotinib
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 57
Completed 0
Not Completed 57
Reason Not Completed
Death             42
Lost to Follow-up             3
Study termination             9
Protocol Violation             3
Arm/Group Title Erlotinib
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
Baseline analysis population is represented as the per protocol population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
64.4  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
18
  33.3%
Male
36
  66.7%
1.Primary Outcome
Title Progression-free Survival
Hide Description 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.
Time Frame Baseline to the end of the study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.4 to 2.6)
2.Secondary Outcome
Title Best Overall Response
Hide Description 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.
Time Frame Baseline to the end of the study (up to 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: Percentage of participants
Complete Response
0.0
(0.0 to 6.8)
Partial Response
0.0
(0.0 to 6.8)
Stable Disease
34.6
(21.9 to 49.0)
Progressive Disease
65.4
(50.9 to 78.0)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from Baseline until death from any cause.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib
Hide Arm/Group Description:

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: Erlotinib was supplied as tablets in the retail product Tarceva.

Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(3.3 to 8.6)
4.Secondary Outcome
Title Percentage of Participants Who Developed Rash
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.7
(46.7 to 73.5)
5.Secondary Outcome
Title Percentage of Participants Who Developed Diarrhea
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.8
(29.7 to 56.8)
Time Frame Time frame is up to 2 years
Adverse Event Reporting Description Safety analysis population: All participants who received at least 1 dose of erlotinib.
 
Arm/Group Title Erlotinib
Hide Arm/Group Description 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.
All-Cause Mortality
Erlotinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Erlotinib
Affected / at Risk (%) # Events
Total   17/57 (29.82%)    
Blood and lymphatic system disorders   
Anaemia  1  1/57 (1.75%)  1
Cardiac disorders   
Sinus tachycardia  1  1/57 (1.75%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/57 (1.75%)  1
Nausea  1  1/57 (1.75%)  1
Vomiting  1  1/57 (1.75%)  1
General disorders   
General physical health deterioration  1  3/57 (5.26%)  3
Pyrexia  1  2/57 (3.51%)  2
Infections and infestations   
Infection  1  1/57 (1.75%)  1
Pneumonia  1  2/57 (3.51%)  2
Investigations   
C-reactive protein increase  1  1/57 (1.75%)  1
Hepatic enzyme increased  1  1/57 (1.75%)  1
Procalcitonin increased  1  1/57 (1.75%)  1
Weight decreased  1  1/57 (1.75%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  1/57 (1.75%)  1
Dehydration  1  1/57 (1.75%)  1
Hypokalaemia  1  1/57 (1.75%)  1
Hyponatraemia  1  1/57 (1.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib
Affected / at Risk (%) # Events
Total   51/57 (89.47%)    
Blood and lymphatic system disorders   
Anaemia  1  5/57 (8.77%)  5
Eye disorders   
Conjunctivities  1  3/57 (5.26%)  3
Gastrointestinal disorders   
Diarrhea  1  25/57 (43.86%)  25
Nausea  1  5/57 (8.77%)  5
Vomiting  1  4/57 (7.02%)  4
General disorders   
Asthenia  1  6/57 (10.53%)  6
Pyrexia  1  5/57 (8.77%)  5
Fatigue  1  4/57 (7.02%)  4
General physical health deterioration  1  4/57 (7.02%)  4
Chest pain  1  3/57 (5.26%)  3
Investigations   
Weight decreased  1  8/57 (14.04%)  8
Metabolism and nutrition disorders   
Decreased appetite  1  13/57 (22.81%)  13
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  3/57 (5.26%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/57 (8.77%)  5
Dyspnoea  1  3/57 (5.26%)  3
Skin and subcutaneous tissue disorders   
Rash  1  35/57 (61.40%)  35
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664533    
Other Study ID Numbers: ML25708
First Submitted: August 10, 2012
First Posted: August 14, 2012
Results First Submitted: October 9, 2015
Results First Posted: December 28, 2015
Last Update Posted: December 28, 2015