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Could targeted drugs spare brain cancer patients from radiation after surgery?

NCT ID NCT07655583

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 4 times

Summary

This pilot study explores whether people with melanoma or non-small cell lung cancer that has spread to the brain can safely skip stereotactic radiosurgery (focused radiation) after having a brain tumor surgically removed. Instead of radiation, participants receive systemic therapy tailored to their cancer type—such as immune checkpoint inhibitors for melanoma or targeted pills for certain lung cancers. The goal is to see if these drugs alone can prevent the tumor from coming back at the surgical site, potentially avoiding the side effects of radiation.

What this could mean

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

Active substance
systemic therapy (immune checkpoint inhibitors for melanoma; osimertinib for EGFR-mutant NSCLC; brigatinib, alectinib, or lorlatinib for ALK-positive NSCLC)
What this could lead to
If successful, this approach could allow some patients to avoid brain radiation after surgery, relying instead on targeted drugs or immunotherapy to prevent recurrence.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply broadly. The cancer could still return in the brain without radiation, and the drugs have their own side effects.

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 20 people

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

Started

May 2026

Expected to finish

Jun 2030

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

18 years and older

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.

Eligibility Criteria 1. Age ≥ 18 years. 2. ECOG performance status ≤ 2. 3. Participants with a resected brain metastasis with gross total resection and pathologic confirmation of NSCLC or melanoma. Gross total resection must be confirmed based on a review of the operative report, pathology, and all post-operative images available at the time of enrollment. 4. Brain metastasis resection occurred ≤ 5 weeks ago. 5. Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is confirmed pathologically at the most recent resection. 6. The resected lesion has never previously been targeted by radiotherapy. 7. Evaluation by a brain metastasis multidisciplinary team (BM-MDT), consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon, and agreement that the intracranial cavity does not or will not require immediate post-operative radiation (i.e. it is judged to be safe to omit post-operative radiation). This BM-MDT evaluation can take place in clinic or during a multidisciplinary conference, either before or after the surgical resection. If the BM-MDT evaluation was before the surgical resection, there can be no new findings in the interim (e.g. during or after the surgical resection) that would change the BM-MDT's recommendation, as determined by one or more of the patient's treating physicians. 8. Documentation by the patient's primary medical oncologist of a planned study systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant (e.g. Exon 19 deletion; L858R) NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC. As new agents are approved, other highly-CNS active tyrosine kinase inhibitors for participants with NSCLC may be included at the discretion of the principal investigator. 9. For a participant with more than one recently resected brain metastasis that meets eligibility criteria #3-#7 above, it is permissible (but not mandated) for more than one surgical cavity to proceed without immediate post-operative radiation. All other intracranial disease must proceed with treatment according to standard-of-care practices at the time of enrollment. This may include treatment with SRS or observation if clinically appropriate. 10. Regarding prior systemic therapy: 1. For participants with melanoma: no prior disease progression on any immune checkpoint inhibitor agent and ≥ 6 months between the last dose of any immune checkpoint inhibitor agent and initiation of the study systemic therapy regimen. 2. For participants with EGFR Mutant NSCLC: no prior disease progression on any EGFR-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any EGFR-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen. 3. For participants with ALK rearranged/fusion positive NSCLC: no prior disease progression on any ALK-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any ALK-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen. 11. This study will allow non-English speaking subjects to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will be translated into the language of the subject after 2 or more occurrences. This will apply to any MD Anderson patient. Exclusion Criteria 1. History of known leptomeningeal involvement (radiographic or cytological). 2. Subjects that have previously received or are currently planned for whole brain radiotherapy. 3. Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy. 4. Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled. 5. Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast. 6. Pregnancy or plans to become pregnant during the duration of the study.

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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 places running it

    1 site. 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

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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