Chemotherapy in Treating Patients With Lung Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Any platinum-based doublet chemotherapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pemetrexed + platinum<br>Patients with pemetrexed + platinum doublet, with or without additional targeted agents | Drug: Any platinum-based doublet chemotherapy<br>* Dosage, dosage form, frequency and duration according to daily hospital practice<br>|
| gemcitabine + platinum<br>Patients with gemcitabine + platinum doublet, with or without additional targeted agents | Drug: Any platinum-based doublet chemotherapy<br>* Dosage, dosage form, frequency and duration according to daily hospital practice<br>|
| taxanes + platinum<br>Patients with taxanes + platinum doublet, with or without additional targeted agents | Drug: Any platinum-based doublet chemotherapy<br>* Dosage, dosage form, frequency and duration according to daily hospital practice<br>|
| vinorelbine + platinum<br>Patients with vinorelbine + platinum doublet, with or without additional targeted agents | Drug: Any platinum-based doublet chemotherapy<br>* Dosage, dosage form, frequency and duration according to daily hospital practice<br>|
| others + platinum<br>Patients with other platinum-based doublet, with or without additional targeted agents | Drug: Any platinum-based doublet chemotherapy<br>* Dosage, dosage form, frequency and duration according to daily hospital practice<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic, Advanced, Stage IIIB-IV, daily, hospital, practice, setting