An Observational Study of Tarceva as Second-Line Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Pemetrexed in First-Line (TIME)
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664533
First received: August 10, 2012
Last updated: February 5, 2015
Last verified: February 2015
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Purpose
This prospective, multicenter observational study will evaluate the efficacy, safety and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up or study termination, whichever occurs first.
| Condition |
|---|
|
Non-Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best overall response (tumor assessments according to RECIST or other criteria) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Best confirmed overall response [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Disease control rate [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 59 |
| Study Start Date: | September 2011 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable stage III or IV according to 7th TNM classification)
- Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent)
Exclusion Criteria:
- Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced NSCLC setting
- Contraindication for Tarceva according to the Summary of Product characteristics
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664533
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664533
Locations
| Belgium | |
| Aalst, Belgium, 9300 | |
| Antwerpen, Belgium, 2020 | |
| Boussu, Belgium, 7360 | |
| Bruxelles, Belgium, 1200 | |
| Charleroi, Belgium, 6000 | |
| Dendermonde, Belgium, 9200 | |
| Duffel, Belgium, 2570 | |
| Edegem, Belgium, 2650 | |
| Frameries, Belgium, 7080 | |
| Genk, Belgium, 3600 | |
| Gilly, Belgium, 6060 | |
| Gosselies, Belgium, 6041 | |
| Liege, Belgium, 4000 | |
| Mons, Belgium, 7000 | |
| Montegnée, Belgium, 4420 | |
| Namur, Belgium, 5000 | |
| Ottignies, Belgium, 1340 | |
| Roeselare, Belgium, 8800 | |
| Sint Niklaas, Belgium, 9100 | |
| Tournai, Belgium, 7500 | |
| Turnhout, Belgium, 2300 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01664533 History of Changes |
| Other Study ID Numbers: | ML25708 |
| Study First Received: | August 10, 2012 |
| Last Updated: | February 5, 2015 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
ClinicalTrials.gov processed this record on February 27, 2015