Chemotherapy in Treating Patients With Lung Cancer (FRAME)

August 23, 2012 updated by: Eli Lilly and Company

First-line Treatment of Non-Small Cell Lung Cancer Under Routine Conditions: Observational Study on Overall Survival

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure
Time Frame
One-year survival rate
Time Frame: 12 months
12 months
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)
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)
Best tumor response
Time Frame: Treatment start to progression or treatment end
Treatment start to progression or treatment end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 23, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13095
  • H3E-EW-B012 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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