Non-small Cell Lung Cancer Study US75 (Z-PACT) (ZPACT)

Novartis

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: zoledronic acid; Drug: Taxotere; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00086268

CZOL446EUS75

US 75

Details and patient eligibility

About

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female patients at least of 18 years old
• Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery
• Women must not be pregnant or attempting to become pregnant
• Able and willing to sign informed consent

Exclusion criteria

• Patients with cancer that has spread to the bone
• Patients with cancer that has spread to the brain who are receiving treatment
• Patients with kidney disease
• Patients treated with other investigational drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Zometa®

Experimental group

Description:

4mg monthly for 12 months from date of first chemotherapy dose

Treatment:

Drug: zoledronic acid

Drug: Carboplatin

Drug: Taxotere

no further treatment

No Intervention group

Description:

Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose