Non-Small-Cell Lung Cancer, Pleural Effusion, Malignant
Conditions
Keywords
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
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.
Interventions
DRUGzoledronic acid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Patients with an SRE will be evaluated for: | — |
| Group 2: Obervational | — |
| Overall survival | — |
| Time from stage IIIB/IV NSCLC diagnosis to progression to bone | — |
Countries
United States
Outcome results
None listed