An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (TIME)
This study has been completed.
Sponsor:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664533
First Posted: August 14, 2012
Last Update Posted: December 28, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 | Intervention |
|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Drug: Erlotinib |
| 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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years) ]Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary Outcome Measures:
- Best Overall Response [ Time Frame: Baseline to the end of the study (up to 2 years) ]Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). 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 appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
- Overall Survival [ Time Frame: Up to 2 years ]Overall survival was defined as the time from Baseline until death from any cause.
- Percentage of Participants Who Developed Rash [ Time Frame: Up to 2 years ]
- Percentage of Participants Who Developed Diarrhea [ Time Frame: Up to 2 years ]
| Enrollment: | 57 |
| Study Start Date: | September 2011 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Erlotinib
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
|
Drug: Erlotinib
Erlotinib was supplied as tablets in the retail product Tarceva.
Other Name: Tarceva
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 the 7th TNM Classification of Malignant Tumors).
- 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 non-small cell lung cancer (NSCLC) setting.
- Contraindication for Tarceva according to the Summary of Product characteristics.
Contacts and Locations
Information from the National Library of Medicine
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): 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
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01664533 History of Changes |
| Other Study ID Numbers: |
ML25708 |
| First Submitted: | August 10, 2012 |
| First Posted: | August 14, 2012 |
| Results First Submitted: | October 9, 2015 |
| Results First Posted: | December 28, 2015 |
| Last Update Posted: | December 28, 2015 |
| Last Verified: | November 2015 |
Additional relevant MeSH terms:
|
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 Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |