A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
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ClinicalTrials.gov Identifier: NCT01342965 |
Recruitment Status :
Completed
First Posted : April 27, 2011
Results First Posted : February 24, 2015
Last Update Posted : February 24, 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: Erlotinib Drug: Chemotherapy |
Enrollment | 217 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Erlotinib | Chemotherapy |
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Arm/Group Description | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. |
Period Title: Overall Study | ||
Started | 110 | 107 |
Received Treatment | 110 | 104 |
Completed | 1 | 0 |
Not Completed | 109 | 107 |
Reason Not Completed | ||
Death | 58 | 57 |
Lost to Follow-up | 5 | 3 |
Other Reasons- Unspecified | 44 | 38 |
Withdrawal by Subject | 2 | 9 |
Baseline Characteristics
Arm/Group Title | Erlotinib | Chemotherapy | Total | |
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Arm/Group Description | Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity. | Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first. | Total of all reporting groups | |
Overall Number of Baseline Participants | 110 | 107 | 217 | |
Baseline Analysis Population Description |
Full analysis set: All randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 110 participants | 107 participants | 217 participants | |
56.7 (10.37) | 55.8 (10.41) | 56.3 (10.37) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 110 participants | 107 participants | 217 participants | |
Female |
68 61.8%
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65 60.7%
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133 61.3%
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Male |
42 38.2%
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42 39.3%
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84 38.7%
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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 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
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 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: | NCT01342965 |
Other Study ID Numbers: |
YO25121 |
First Submitted: | April 26, 2011 |
First Posted: | April 27, 2011 |
Results First Submitted: | February 5, 2015 |
Results First Posted: | February 24, 2015 |
Last Update Posted: | February 24, 2015 |