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New combo attack on lung tumors: immunotherapy, radiation, and surgery

NCT ID NCT06492954

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing whether combining an immunotherapy drug (atezolizumab) with targeted radiation and surgery is safe for people whose osteosarcoma has come back in the lungs. About 12 participants will receive the drug, radiation to one lung nodule, and then surgery to remove all visible lung tumors. The main goal is to find the safest dose and see if the combination can keep the cancer from growing for at least a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Atezolizumab (an immunotherapy drug that helps the immune system attack cancer cells)
What this could lead to
If this combination proves safe and effective, it could offer a new treatment option for people whose osteosarcoma has come back in the lungs, potentially helping to control the disease longer.
What could go wrong
This is a very early Phase 1 trial with only 12 participants, so it is primarily testing safety and dosing. The combination may not work better than existing treatments, and side effects from immunotherapy, radiation, and surgery could be significant.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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.

Ages

Up to 50 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: * Participants must have had histologic verification of osteosarcoma at the original diagnosis or relapse * Participants must be in first or greater relapse of osteosarcoma * Recurrence must be limited to the lung but can be unilateral or bilateral * All pulmonary nodules must be resectable as determined by the institutional surgeon. Resectable pulmonary nodules are defined as nodules that can be removed without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels). There is no maximum number of lesions provided the surgeon thinks a complete surgical remission can be achieved. * Participants must have at least 1 lesion that is ≥ 5 mm and meets the criteria to receive SBRT AND an additional nodule(s) that meets protocol definition for a metastatic nodule necessitating surgical resection: single nodule ≥ 5 mm, or ≥ 2 nodules ≥ 3 mm in size * Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 60, or ECOG performance score of ≤ 2 * All prior treatment-related toxicities must have resolved to ≤ Grade 1 OR be determined clinically stable by the treating investigator. 1. Myelosuppressive chemotherapy: ≥ 14 days after the last dose of myelosuppressive chemotherapy. 2. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., Pegfilgrastim) or 7 days for a short-acting growth factor. 3. Biologic (anti-neoplastic) agent: ≥ 7 days after the last dose of a biologic agent. 4. Cellular therapy: ≥ 21 days must have elapsed from the last dose of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) with resolution of any associated toxicities. 5. Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ≥ 21 days must have elapsed from the last dose of interleukins, interferon, or cytokines (other than hematopoietic growth factors). 6. Antibodies: 7 days or 3 half-lives (whichever is longer) but not longer than 30 days, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1. 7. Autologous Stem Cell Transplant or Rescue: ≥ 6 weeks must have elapsed since stem cell transplant or rescue. 8. Radiotherapy (XRT): ≥ 14 days after local palliative XRT (small port); ≥ 3 months must have elapsed if prior craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow radiation was given. 9. Investigational Agents Not Otherwise Specified: ≥ 28 days must have elapsed since the last dose of any investigational agent not specified above. 10. Thoracic Surgery or Procedure: ≥ 28 days must have elapsed since prior thoracotomy, thoracoscopy, or thoracentesis. * Adequate Bone Marrow Function Defined: Peripheral absolute neutrophil count (ANC) ≥ 750/mm3, Platelet count ≥ 50,000/mm3. Must be transfusion independent defined as not receiving platelet transfusions for at least 7 days before enrollment * Adequate Renal Function Defined As Creatinine clearance or radioisotope ≥ GFR 70ml/min/1.73 m2 * Adequate Liver Function Defined As Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age, ALT (SGPT) ≤ 3 x the ULN. For this study, the ULN for ALT (SGPT) is 45 U/L. * Adequate Pancreatic Function Defined As Serum lipase ≤ 1.5 x ULN * Adequate Thyroid Function Defined As Normal free T4 * Adequate Pulmonary Function Defined As No dyspnea at rest, Pulse oximetry \> 92% on room air * Adequate Cardiac Function Defined As QTc ≤ 480 msec, Shortening fraction ≥ 27% by echocardiogram or ejection fraction ≥ 50% by gated radionuclide study or echocardiogram * Urine protein: Meets one of the following criteria: (1) urinary protein by urine dipstick is ≤ 100 mg/dL or ≤ 2+; OR (2) Urine Protein Creatinine (UPC) ratio \< 3.5; OR (3) if 24-hour urine protein was measured, urinary protein ≤ 3500 mg. * Life expectancy of at least 4 months. * Negative urine or serum pregnancy test in women of childbearing potential. * Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Patients should maintain adequate contraception for at least 5 months after the last dose of atezolizumab. Adequate contraception is defined as abstinence or use of contraceptives with a failure rate of \< 1% per year. * All participants and their parents or legal guardians must sign a written informed consent and assent (if applicable). Exclusion Criteria: * Pregnancy or Breast-Feeding * Active metastatic disease outside of the lungs including bone, CNS, or any extrapulmonary involvement * \> Grade 1 pleural effusion * Prior lung radiation * Active autoimmune disorder that has required systemic treatment in the past 12 months, or a documented history of severe autoimmune disorder, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment may be permitted to enroll. * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months before initiation of study treatment, unstable arrhythmia, or unstable angina. * Prior treatment with an immune checkpoint inhibitor is allowed provided it was not permanently discontinued due to toxicity and was not given with radiation. * Active tuberculosis * Any medical condition or illness that would compromise the participants's ability to undergo surgery, cause unacceptable safety risk, or compromise compliance with the protocol. * Chronic use of immunosuppressive therapies. * Participants with an uncontrolled infection. * Subjects who have received prior allogeneic stem cell transplant or solid organ transplant are not eligible. * Participants who, in the opinion of the investigator, may not be able to comply with the protocol-required procedures. * Participants who are currently receiving any other investigational or anti-cancer agents. * Participants with a known history of HIV, hepatitis B, and/or hepatitis C (testing not required as part of screening). * Current or prior pneumonitis. * Live/attenuated vaccine administered within 30 days of enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Chilldren's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

    Contact Email: •••••@•••••

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