A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00556322 |
Recruitment Status :
Completed
First Posted : November 12, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Non-Small Cell Lung Cancer |
Interventions |
Drug: Alimta or Taxotere Drug: erlotinib [Tarceva] |
Enrollment | 424 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Comparator | Erlotinib |
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Arm/Group Description | Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label. | Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death. |
Period Title: Overall Study | ||
Started | 221 | 203 |
Completed | 0 [1] | 0 [1] |
Not Completed | 221 | 203 |
Reason Not Completed | ||
Insufficient therapeutic response | 158 | 168 |
Adverse Event | 7 | 4 |
Other | 4 | 1 |
Lost to Follow-up | 5 | 3 |
Withdrawal by Subject | 19 | 7 |
Protocol Violation | 5 | 1 |
Ongoing at data cutoff | 3 | 5 |
Death | 20 | 14 |
[1]
Data cutoff was 01 August 2010
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Baseline Characteristics
Arm/Group Title | Comparator | Erlotinib | Total | |
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Arm/Group Description | Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label. | Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death. | Total of all reporting groups | |
Overall Number of Baseline Participants | 221 | 203 | 424 | |
Baseline Analysis Population Description |
Full Analysis Set (FAS): All participants randomized were included according to the therapy that they were randomized to receive in the FAS population.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 221 participants | 203 participants | 424 participants | |
58.3 (9.90) | 58.6 (9.64) | 58.4 (9.76) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 221 participants | 203 participants | 424 participants | |
Female |
61 27.6%
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42 20.7%
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103 24.3%
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Male |
160 72.4%
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161 79.3%
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321 75.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 after the first publication or presentation that involves the overall study. 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
Name/Title: | Medical Communications |
Organization: | Hoffmann- LaRoche |
Phone: | 1-800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00556322 |
Other Study ID Numbers: |
BO18602 |
First Submitted: | November 9, 2007 |
First Posted: | November 12, 2007 |
Results First Submitted: | December 3, 2014 |
Results First Posted: | February 23, 2015 |
Last Update Posted: | February 23, 2015 |