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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664533
First received: August 10, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This prospective, multicenter observational study will evaluate the efficacy, sa fety and tolerability of Tarceva (erlotinib) as second-line treatment in patient s with locally advanced or metastatic non-small cell lung cancer (NSCLC) who hav e progressed after pemetrexed-containing first-line chemotherapy. Eligible patie nts will be followed until withdrawal of consent, lost-to-follow-up or study ter mination, 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)

  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

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: August 4, 2014
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014