Chemotherapy in Treating Patients With Lung Cancer

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Any platinum-based doublet chemotherapy

• Registration Number: NCT01067794
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1610

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

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Exclusion Criteria

• Participating simultaneously in a study including administration of any investigational drug or procedure at entry into this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pemetrexed + platinum	Any platinum-based doublet chemotherapy	Patients with pemetrexed + platinum doublet, with or without additional targeted agents
gemcitabine + platinum	Any platinum-based doublet chemotherapy	Patients with gemcitabine + platinum doublet, with or without additional targeted agents
taxanes + platinum	Any platinum-based doublet chemotherapy	Patients with taxanes + platinum doublet, with or without additional targeted agents
vinorelbine + platinum	Any platinum-based doublet chemotherapy	Patients with vinorelbine + platinum doublet, with or without additional targeted agents
others + platinum	Any platinum-based doublet chemotherapy	Patients with other platinum-based doublet, with or without additional targeted agents

Primary Outcome Measures

Name	Time	Method
Overall survival	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

Name	Time	Method
One-year survival rate	12 months
Progression-free survival	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	Treatment start to progression or treatment end