Chemotherapy in Treating Patients With Lung Cancer (FRAME)
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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 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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013