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Chemotherapy in Treating Patients With Lung Cancer

NCT ID: NCT01067794

Last Updated: 2012-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Non Small Cell Lung Cancer

Keywords

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Metastatic Advanced Stage IIIB-IV daily hospital practice setting

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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pemetrexed + platinum

Patients with pemetrexed + platinum doublet, with or without additional targeted agents

Any platinum-based doublet chemotherapy

Intervention Type DRUG

Dosage, dosage form, frequency and duration according to daily hospital practice

gemcitabine + platinum

Patients with gemcitabine + platinum doublet, with or without additional targeted agents

Any platinum-based doublet chemotherapy

Intervention Type DRUG

Dosage, dosage form, frequency and duration according to daily hospital practice

taxanes + platinum

Patients with taxanes + platinum doublet, with or without additional targeted agents

Any platinum-based doublet chemotherapy

Intervention Type DRUG

Dosage, dosage form, frequency and duration according to daily hospital practice

vinorelbine + platinum

Patients with vinorelbine + platinum doublet, with or without additional targeted agents

Any platinum-based doublet chemotherapy

Intervention Type DRUG

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

Any platinum-based doublet chemotherapy

Intervention Type DRUG

Dosage, dosage form, frequency and duration according to daily hospital practice

Interventions

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Any platinum-based doublet chemotherapy

Dosage, dosage form, frequency and duration according to daily hospital practice

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

References

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Schnabel PA, Smit E, Carpeno Jde C, Lesniewski-Kmak K, Aerts J, Kraaij K, Visseren-Grul C, Dyachkova Y, Taipale K, Girvan A, Moro-Sibilot D. Influence of histology and biomarkers on first-line treatment of advanced non-small cell lung cancer in routine care setting: baseline results of an observational study (FRAME). Lung Cancer. 2012 Dec;78(3):263-9. doi: 10.1016/j.lungcan.2012.09.001. Epub 2012 Oct 4.

Reference Type DERIVED
PMID: 23040326 (View on PubMed)

Other Identifiers

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H3E-EW-B012

Identifier Type: OTHER

Identifier Source: secondary_id

13095

Identifier Type: -

Identifier Source: org_study_id