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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664533
First received: August 10, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664533

Contacts
Contact: Please reference Study ID Number: ML25708 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Belgium
Recruiting
Aalst, Belgium, 9300
Completed
Antwerpen, Belgium, 2020
Active, not recruiting
Boussu, Belgium, 7360
Active, not recruiting
Bruxelles, Belgium, 1200
Recruiting
Charleroi, Belgium, 6000
Active, not recruiting
Dendermonde, Belgium, 9200
Active, not recruiting
Duffel, Belgium, 2570
Completed
Edegem, Belgium, 2650
Recruiting
Frameries, Belgium, 7080
Completed
Genk, Belgium, 3600
Recruiting
Gilly, Belgium, 6060
Completed
Gosselies, Belgium, 6041
Active, not recruiting
Liege, Belgium, 4000
Recruiting
Mons, Belgium, 7000
Not yet recruiting
Montegnée, Belgium, 4420
Terminated
Namur, Belgium, 5000
Completed
Ottignies, Belgium, 1340
Completed
Roeselare, Belgium, 8800
Active, not recruiting
Sint Niklaas, Belgium, 9100
Completed
Tournai, Belgium, 7500
Active, not recruiting
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: May 7, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 22, 2013