Chemotherapy in Treating Patients With Lung Cancer (FRAME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01067794
First received: February 1, 2010
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

This observational study was planned, with the primary objective to observe patient survival following first-line treatment of patients of Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) with different platinum-based doublets under routine disease management conditions. Further secondary objectives of this study are to provide insights to what extent histologic subtyping and the use of additional prognostic or predictive biomarkers are currently considered for differential therapeutic decisions under routine conditions. All of these data are critical to evaluate the factors for differential therapeutic decisions and their effect on patient outcomes in a real life setting, and they can only be obtained through observational research.


Condition Intervention
Non Small Cell Lung Cancer
Drug: Any platinum-based doublet chemotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Treatment start to death from any cause (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One-year survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Treatment start to progression or death (follow-up assessments until death or until end of study, up to 18 months from Last Patient Entered Treatment) ] [ Designated as safety issue: No ]
  • Best tumor response [ Time Frame: Treatment start to progression or treatment end ] [ Designated as safety issue: No ]

Estimated Enrollment: 1610
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pemetrexed + platinum
Patients with pemetrexed + platinum doublet, with or without additional targeted agents
Drug: Any platinum-based doublet chemotherapy
Dosage, dosage form, frequency and duration according to daily hospital practice
gemcitabine + platinum
Patients with gemcitabine + platinum doublet, with or without additional targeted agents
Drug: Any platinum-based doublet chemotherapy
Dosage, dosage form, frequency and duration according to daily hospital practice
taxanes + platinum
Patients with taxanes + platinum doublet, with or without additional targeted agents
Drug: Any platinum-based doublet chemotherapy
Dosage, dosage form, frequency and duration according to daily hospital practice
vinorelbine + platinum
Patients with vinorelbine + platinum doublet, with or without additional targeted agents
Drug: Any platinum-based doublet chemotherapy
Dosage, dosage form, frequency and duration according to daily hospital practice
others + platinum
Patients with other platinum-based doublet, with or without additional targeted agents
Drug: Any platinum-based doublet chemotherapy
Dosage, dosage form, frequency and duration according to daily hospital practice

  Eligibility

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 (> 18 yrs.) initiating first-line treatment for advanced or metastatic (stage IIIB-IV) NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents treated in public hospitals, private hospitals or by office based physicians

Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IV
  • Initiation of first-line treatment for advanced NSCLC with any platinum-based doublet chemotherapy, with or without additional targeted agents
  • 18 years of age or older

Exclusion Criteria:

  • Participating simultaneously 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 ClinicalTrials.gov identifier: NCT01067794

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01067794     History of Changes
Other Study ID Numbers: 13095, H3E-EW-B012
Study First Received: February 1, 2010
Last Updated: August 23, 2012
Health Authority: Finland: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Ethics Committee for Clinical Research
Romania: Ministry of Public Health

Keywords provided by Eli Lilly and Company:
Metastatic
Advanced
Stage IIIB-IV
daily
hospital
practice
setting

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 October 29, 2014