Chemotherapy in Treating Patients With Lung Cancer

NCT01067794 | Completed

• 2 other identifiers: 13095H3E-EW-B012
• Study Type: observational
• Target: 1,610
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Metastatic; Advanced; Stage IIIB-IV; daily; hospital; practice; setting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (5)

pemetrexed + platinum

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

Drug: Any platinum-based doublet chemotherapy

gemcitabine + platinum

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

Drug: Any platinum-based doublet chemotherapy

taxanes + platinum

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

Drug: Any platinum-based doublet chemotherapy

vinorelbine + platinum

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

Drug: Any platinum-based doublet chemotherapy

others + platinum

Patients with other platinum-based doublet, with or without additional targeted agents

Drug: Any platinum-based doublet chemotherapy

Interventions

Any platinum-based doublet chemotherapy DRUG

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

gemcitabine + platinum; others + platinum; pemetrexed + platinum; taxanes + platinum; vinorelbine + platinum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• years of age or older

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Related Publications (1)

• 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.

  PMID: 23040326 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 12, 2010
• Study Start: April 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 24, 2012

Record last verified: 2012-08