Non-small Cell Lung Cancer Registry

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.

Official Title
-----------------
A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

Conditions
-----------------
Non-Small-Cell Lung Cancer, Pleural Effusion, Malignant

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma). Unresectable Stage IIIB with pleural effusion or stage IV NSCLC ECOG performance status of 0 or 1 Exclusion Criteria: Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid) Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate) Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate) Abnormal renal function or creatinine clearance Unstable brain metastasis Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases |  |  | 
| Group 2: Observational |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with an SRE will be evaluated for: |  |  | 
| Time from stage IIIB/IV NSCLC diagnosis to progression to bone |  |  | 
| Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications |  |  | 
| The effect of serum NTX levels on the development of skeletal events (SREs), and |  |  | 
| Overall survival |  |  | 
| Group 2: Obervational |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Bone Metastases, Bone Markers, NTX, zoledronic acid, Registry, Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC), Unresectable Stage IIIB NSCLC with Pleural Effusion