Performance Status During Treatment With Pemetrexed in Patients With NSCLC (PERFORMANCE)

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: October 4, 2007
Last updated: March 28, 2011
Last verified: March 2011
The primary research objective of this observational study in pretreated patients with NSCLC of Stage IIIa/b or Stage IV is to evaluate patients' Karnofsky Index (KI) after the second cycle of second-line treatment with single agent pemetrexed in a real life setting, and to evaluate factors potentially influencing performance status in terms of KI, i.e. frequency of use of concomitant medications, in particular analgesics, folic acid, Vitamin B12, antiemetics, and medications against diarrhea; as documented in patient diary (days of use per week) and by the physicians.

Condition Intervention
Non Small Cell Lung Cancer
Drug: Pemetrexed

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Status and Influencing Factors During Second-Line Treatment With Pemetrexed in Patients With Stage III/IVNon Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Enrollment: 542
Study Start Date: September 2007
Study Completion Date: March 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Second-line pemetrexed treatment in NSCLC
Patients with NSCLC who will start second-line treatment with pemetrexed.
Drug: Pemetrexed
in-label use
Other Name: Alimta


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with NSCLC Stage IIIa/b or IV who have previously been treated with chemotherapy and are starting second-line treatment with single-agent pemetrexed are eligible for this observational study. Patients must have received one prior chemotherapy regimen. Patients who received prior neoadjuvant or adjuvant therapy are also eligible. Both, in- and outpatients are eligible.

Inclusion Criteria:

  • Are 18 years of age or older
  • Have NSCLC, Stage IIIa/b or IV, that is not amenable to curative therapy
  • Have had one prior chemotherapy regimen with cytotoxic agents for the treatment of NSCLC (patients with adjuvant and neoadjuvant regimens are also eligible. However, patients with one prior cytotoxic chemotherapy followed by a targeted agent such as erlotinib are not eligible because the targeted agent would be regarded as second-line treatment)
  • Are initiating second-line of treatment for NSCLC with pemetrexed
  • Have been fully informed and have given written consent for the use of their data.

Exclusion Criteria:

  • Have received any prior treatment with pemetrexed
  • Are participating in a study including administration of any investigational drug or procedure at entry into this study
  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 identifier: NCT00540241

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bad Homburg, Germany, 61352
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00540241     History of Changes
Other Study ID Numbers: 11826  H3E-SB-B007 
Study First Received: October 4, 2007
Last Updated: March 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2016