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Lung cancer bone spread study seeks 100 volunteers

NCT ID NCT03958565

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how bone tumors respond to treatment in people with non-small cell lung cancer. Researchers will measure bone health markers in urine and blood before and after treatment. The goal is to see if targeted pills (TKIs) or standard treatments like chemotherapy or immunotherapy help reduce bone damage. Participants must be 18-100 years old with confirmed lung cancer that has spread to bones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

About 30-40% of patients w/ lung cancer develop bone metastases during their disease; the median survival time of patients w/ this secondary lesion is 7 months. In a retrospective study of 259 non-small cell lung cancer (NSCLC) patients, the most common site of skeletal metastases was the spine in 50% of patients, followed by the ribs (27.1%), ilium (10%), sacrum (7.1%), femur (5.7%) \&humerus, scapula \& sternum (2.9%). At our institution, it is standard practice not to use anti-bone resorptive therapy in driver mutation-addicted NSCLC w/ bony metastasis, while anti-bone resorptive therapies are commonly used in NSCLC w/ bony metastases w/o any actionable driver mutation. This study relates to exploring the potential differential need for anti-resorptive bone medications (bisphosphonates or RANK-L inhibitors) in patients w/ advanced non-small cell lung cancer \& bone metastases w/ \& w/o actionable driver mutations.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision to sign and date the consent form 2. Stated willingness to comply with all study procedures and be available for the duration of the study 3. Be a male or female aged 18-100 years 4. Pathologically confirmed non-small cell lung cancer 5. Molecular testing through a CLIA-validated NGS assay. This can be done using either tissue based samples or blood-based samples (ctDNA) 6. ECOG PS 0-2 7. Decision to be on a particular standard of care TKI or chemotherapy +/- immunotherapy (clinical decision that would occur prior to study enrollment) 8. Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment 9. Bone metastases must be detected through radiographic imaging prior to enrollment on this study. Exclusion Criteria: 1. Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy a. Excluded anti-bone resorptive therapy includes: zolendronic acid, pamidronate, alendronate, denosumab or any medication that acts as an osteoclast inhibitor 2. Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation while on standard of care treatments for the NSCLC. 3. Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening 4. Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lone Tree Medical Center

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.