Completed
ZPACT

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

zoledronic acid

+ Taxotere
+ Carboplatin
Drug
Who is being recruted

Bronchial Neoplasms
+16

+ Bronchial Neoplasms
+ Bronchial Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleNon-small Cell Lung Cancer Study US75 (Z-PACT) 
NCT00093717NCT00086268
Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
250 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchial Neoplasms
Bronchial Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Bronchogenic
Carcinoma, Bronchogenic
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Lung Neoplasms
Lung Neoplasms
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
4mg monthly for 12 months from date of first chemotherapy dose

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 80 locations
Suspended
Clinical Research ConsultantsHoover, United StatesSee the location
Suspended
Arizona Oncology Assoc.Tucson, United States
Suspended
NEA ClinicJonesboro, United States
Suspended
Highlands Oncology GroupSpringdale, United States
Completed80 Study Centers
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