An Observational Study of Tarceva (Erlotinib) in Routine Practice For First Line Maintenance Therapy in Patients With Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01194050 |
Recruitment Status :
Completed
First Posted : September 2, 2010
Last Update Posted : November 2, 2016
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Condition or disease |
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Non-Squamous Non-Small Cell Lung Cancer |
Study Type : | Observational |
Actual Enrollment : | 289 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Erlotinib (Tarceva) in Routine Clinical Practice for First Line Maintenance Therapy (1LM) in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Group/Cohort |
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Cohort |
- Overall survival at 1 year [ Time Frame: 12 months ]
- Tolerability of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]
- Efficacy of Tarceva in daily clinical practice under routine conditions [ Time Frame: 12 months ]
- Reproducibility of the results of the controlled SATURN study [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Adult patients with locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy
Exclusion Criteria:
- Not willing or not able to sign written informed consent form

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): NCT01194050
Germany | |
Villingen-Schwenningen, Germany, 78052 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01194050 |
Other Study ID Numbers: |
ML22816 |
First Posted: | September 2, 2010 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |