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A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

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ClinicalTrials.gov Identifier: NCT01230710
Recruitment Status : Completed
First Posted : October 29, 2010
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Erlotinib
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib
Hide Arm/Group Description Participants received erlotinib 150 mg orally once a day for 48 weeks.
Period Title: Overall Study
Started 51
Completed 2
Not Completed 49
Reason Not Completed
Disease Progression             41
Lost to Follow-up             3
Death             4
Withdrawal of Consent             1
Arm/Group Title Erlotinib
Hide Arm/Group Description Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
55.5  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
16
  31.4%
Male
35
  68.6%
1.Primary Outcome
Title Percentage of Participants With Progression-free Survival at Week 52
Hide Description A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Time Frame From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All enrolled participants.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Percentage of participants
22.5
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
Time Frame From the date of enrolment until the end of the study (up to 2 years, 6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All enrolled participants.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Participants Analyzed 51
Median (95% Confidence Interval)
Unit of Measure: Days
99
(53.0 to 292.0)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
Time Frame From the date of enrolment until the end of the study (up to 2 years, 6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All enrolled participants.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Participants Analyzed 51
Median (Inter-Quartile Range)
Unit of Measure: Days
671
(392 to 796)
4.Secondary Outcome
Title Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
Hide Description A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Time Frame From the date of enrolment until the end of the study (up to 2 years, 6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Percentage of participants
Complete response 2.1
Partial response 23.4
5.Secondary Outcome
Title Percentage of Participants With Disease Control
Hide Description A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. 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 unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
Time Frame From the date of enrolment until the end of the study (up to 2 years, 6 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Percentage of participants
55.3
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All participants who had received at least 1 dose of erlotinib and had at least 1 safety follow-up, whether withdrawn prematurely or not.
 
Arm/Group Title Erlotinib
Hide Arm/Group Description Participants received erlotinib 150 mg orally once a day for 48 weeks.
All-Cause Mortality
Erlotinib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Erlotinib
Affected / at Risk (%)
Total   4/51 (7.84%) 
Injury, poisoning and procedural complications   
Gastrointestinal toxicity  1  1/51 (1.96%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/51 (1.96%) 
Nervous system disorders   
Convulsions  1  1/51 (1.96%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  1/51 (1.96%) 
Pneumothorax  1  1/51 (1.96%) 
Vascular disorders   
Deep vein thrombosis  1  1/51 (1.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib
Affected / at Risk (%)
Total   32/51 (62.75%) 
Cardiac disorders   
Dyspnoea  1  4/51 (7.84%) 
Gastrointestinal disorders   
Diarrhoea  1  6/51 (11.76%) 
General disorders   
Fever  1  3/51 (5.88%) 
Generalized weakness  1  4/51 (7.84%) 
Nervous system disorders   
Headache  1  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/51 (7.84%) 
Skin and subcutaneous tissue disorders   
Acneiform rash  1  5/51 (9.80%) 
Dry skin  1  4/51 (7.84%) 
Itching  1  3/51 (5.88%) 
Maculopapular rashes  1  3/51 (5.88%) 
Rashes  1  6/51 (11.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: NCT01230710    
Other Study ID Numbers: ML25478
First Submitted: October 28, 2010
First Posted: October 29, 2010
Results First Submitted: February 5, 2015
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015