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

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: High NTX Level; Non Small Cell Lung Cancer; Bone Metastases

Treatments: Drug: zometa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00762346

CZOL446ECN06T

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

1

Experimental group

Treatment:

Drug: zometa