Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00762346

Enrollment

156

Registered

2008-09-30

Start date

2008-09-30

Completion date

2013-03-31

Last updated

2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer, Bone Metastases, High NTX Level

Keywords

non small cell lung cancer, NTX, zometa

Brief summary

A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

Interventions

DRUGzometa

zometa 4mg i.v. every 4 weeks for up to 2 years

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 * Histologically confirmed non-small cell cancer * One bone metastasis at least confirmed by image(X ray, CT or others) * NTX \> 50nM BCE/mM creatinine * Life expectancy \> 6 M * ECOG \<= 2 * Signed ICF

Exclusion criteria

* Women who are pregnant or in lactation * Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled * Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy * Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Design outcomes

Primary

Measure	Time frame
Skeleton-related event	2 years

Secondary

Measure	Time frame
OS	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026