Non-Small-Cell Lung CancerPhase 3NCT00172042
A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Zoledronic acid 4 mg in people with Non-Small-Cell Lung Cancer, run by Novartis Pharmaceuticals at 69 sites in 15 countries.
Trial summary
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Zoledronic acid 4 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 69 sitesin 15 countries
- Study dates
- Mar 2005to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
- Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
- Patients must have received primary treatment for their disease and had no progression
Who cannot join
- Diagnosed with NSCLC longer than 6 months ago
- Treatment with other bisphosphonates in past 12 months
- Presence of metastases
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
69 sites in 15 countries.
69 sites in 15 countries
Germany14 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Coburg
Novartis Investigative Site
Cologne
Novartis Investigative Site
Essen
Novartis Investigative Site
Halle
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Heidelberg
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Ludwigsburg
Novartis Investigative Site
Mannheim
Novartis Investigative Site
München
Novartis Investigative Site
Neumünster
Novartis Investigative Site
Trier
Novartis Investigative Site
Ulm
Italy12 sites
Novartis Investigative Site
Bergamo
Novartis Investigative Site
Carpi
Novartis Investigative Site
Catania
Novartis Investigative Site
Como
Novartis Investigative Site
Cosenza
Novartis Investigative Site
Livorno
Novartis Investigative Site
Novara
Novartis Investigative Site
Orbassano
Novartis Investigative Site
Padova
Novartis Investigative Site
Reggio Calabria
Novartis Investigative Site
Rome
Novartis Investigative Site
Taormina
United Kingdom6 sites
Novartis Investigative Site
Aberdeen
Novartis Investigative Site
Leeds
Novartis Investigative Site
Leicester
Novartis Investigative Site
London
Novartis Investigative Site
Nottingham
Novartis Investigative Site
Sutton
Spain5 sites
Novartis Investigative Site
Alicante
Novartis Investigative Site
Donostia / San Sebastian
Novartis Investigative Site
Madrid
Novartis Investigative Site
Málaga
Novartis Investigative Site
Sabadell
Hungary4 sites
Novartis Investigative Site
Budapest
Novartis Investigative Site
Deszk
Novartis Investigative Site
Mátraháza
Novartis Investigative Site
Pécs
Netherlands4 sites
Novartis Investigative Site
's-Hertogenbosch
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Eindhoven
Novartis Investigative Site
Hoofddorp
Poland4 sites
Novartis Investigative Site
Lodz
Novartis Investigative Site
Olsztyn
Novartis Investigative Site
Poznan
Novartis Investigative Site
Warsaw
Belgium3 sites
Novartis Investigative Site
Jette
Novartis Investigative Site
Leuven
Novartis Investigative Site
Liège
China3 sites
Novartis Investigative Site
Beijing
Novartis Investigative Site
Guangzhou
Novartis Investigative Site
Shanghai
Greece3 sites
Novartis Investigative Site
Athens
Novartis Investigative Site
Patra - RIO
Novartis Investigative Site
Thessaloniki
Portugal3 sites
Novartis Investigative Site
Coimbra
Novartis Investigative Site
Lisbon
Novartis Investigative Site
Porto
Taiwan3 sites
Novartis Investigative Site
Lin-Ko
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taipei
France2 sites
Novartis Investigative Site
Clamart
Novartis Investigative Site
Clémont
Thailand2 sites
Novartis Investigative Site
Bangkok
Novartis Investigative Site
Chaingmai
About this study
Official title: A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Zoledronic acid 4 mg
- Keywords
- Non-Small-Cell Lung Cancer, Bisphosphonates, Zoledronic acid, Bone metastases, Prevention of bone metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid 4 mgDrug
Also called Zometa®
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment. Receives: Drug: Zoledronic acid 4 mg |
| Control | Other | No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed. Receives: Drug: Zoledronic acid 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Measured: Up to 24 months
Kaplan-Meier Estimates for Progression-free Survival
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Measured: Months 6, 12, 18, and 24
Percentage of Participants With Progression-Free Survival Events
Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Measured: Up to 24 months
Secondary outcomes (5)
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months
Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Measured: Months 6, 12, 18 and 24
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases
Time to occurrence of bone metastases was defined as the time from randomization to the date of the first documented bone metastases which could be asymptomatic or symptomatic at the time of detection. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Measured: Months 6, 12, 18, and 24
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry
Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event.
Measured: Months 12 and 24
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)
Time to the first skeletal related event defined as the time from randomization to the date of occurrence of the first SRE. Skeletal Related Events were defined as radiation therapy or surgery to bone, spinal cord compression event or a pathologic bone fracture event
Measured: Months 6,12, 18, and 24
Kaplan-Meier Estimates for Overall Survival
Measured: Months 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172042
- Sponsor's protocol ID
- CZOL446G2419
- Status last verified
- Apr 2015
- First submitted
- 13 Sep 2005
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.
PubMed 22730101
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00172042
- Acronym / sponsor ID
- CZOL446G2419
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Non-Small-Cell Lung Cancer, Bisphosphonates, Zoledronic acid, Bone metastases, Prevention of bone metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 19 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic acid 4 mgZoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment. |
| Control | Other | Drug: Zoledronic acid 4 mgNo investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed Non-small Cell Lung Cancer (NSCLC)
- Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
- Patients must have received primary treatment for their disease and had no progression
Key exclusion criteria (4 listed)
- Diagnosed with NSCLC longer than 6 months ago
- Treatment with other bisphosphonates in past 12 months
- Presence of metastases
- Other protocol-defined inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acid 4 mgAlso: Zometa®Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution). | Drug | Control, Zoledronic acid |
Primary outcome
Progression-Free Survival
Time frame: Up to 24 months
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Kaplan-Meier Estimates for Progression-free Survival
Time frame: Months 6, 12, 18, and 24
Progression-free survival is defined as the time from randomization to the date of the first documented progression or recurrence of disease or death from any cause. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
Percentage of Participants With Progression-Free Survival Events
Time frame: Up to 24 months
Percentage of Participants with the Progression-free survival events: disease progression and death. Time to disease progression (TTP) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines with evaluations every 3 months.
5 secondary outcomes
Percentage of Participants With Bone Metastases at 6, 12, 18, and 24 Months
Time frame: Months 6, 12, 18 and 24
Kaplan-Meier Estimate of the Time to Occurrence of Bone Metastases
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With Skeletal Related Events (SREs) at 12 and 24 Months From Study Entry
Time frame: Months 12 and 24
Kaplan-Meier Estimates of the Time to the First Skeletal Related Event (SRE)
Time frame: Months 6,12, 18, and 24
Kaplan-Meier Estimates for Overall Survival
Time frame: Months 6, 12, 18, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22730101Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
69 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic acid 4 mg in people with Non-Small-Cell Lung Cancer, run by Novartis Pharmaceuticals at 69 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Germany, Italy, United Kingdom, Spain, Hungary and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00172042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.