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Brain mets showdown: radiation plus new combo drug tested in lung cancer

NCT ID NCT07234877

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests two treatment plans for people with lung cancer that has spread to the brain but is not causing major symptoms. One group gets focused radiation to all brain tumors first, then a new immunotherapy drug (ivonescimab) plus chemotherapy. The other group gets the immunotherapy and chemo right away. The goal is to see which approach better delays brain tumor growth. About 158 adults will take part.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 158 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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.

Inclusion Criteria: * Age 18 years or older * ECOG PS \<= 2 * Patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment approved by EMA and recommended by the ESMO guidelines. * Asymptomatic or clinically symptomatic brain metastases defined as requiring a dose of steroids of maximum 4 mg equivalent dexamethasone per day for the last 7 days to control neurological symptoms. With the clinically oligosymptomatic further defined as having no indication for immediate localized brain therapy, including neurosurgery or radiotherapy. Patients with controlled seizures can be enrolled. * Newly diagnosed brain metastasis with the following characteristics: * 1-10 newly diagnosed and untreated (except resected) brain metastases Note: if the neuronavigation MRI in the upfront SRS/FSRT arms shows \> 10 metastases, but the MRI used for enrolment showed 1-10 metastases, the patient will be still considered eligible. * At least one metastasis should be at least 5x5 mm. In case of doubt on the diagnosis of brain metastasis, the lesion should not be irradiated but followed up. * The largest metastasis must be \<10 mL in volume and \<30 mm in longest diameter (resected lesions would not count). * The maximum cumulative volume of brain metastases must be \<30 mL (resected lesions would not count) * Adequate Organ Function Exclusion Criteria: * Patients with oligometastatic NSCLC who are scheduled to receive radical local treatment to extra-cranial sites. * Patients with contra-indications to brain MRI with gadolinium-based contrast agent. * Active auto-immune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Patients with \>30 Gy of chest radiation therapy within 6 months prior to randomization; non-thoracic radiation therapy \>30Gy within 4 weeks prior to randomization, or palliative radiation therapy of ≤30 Gy within 7 days prior to randomization. * Prior brain irradiation (including whole brain radiotherapy and SRS). * Prior systemic treatment for metastatic NSCLC. Patients having received adjuvant or neoadjuvant chemotherapy or curative-intent chemoradiotherapy with or without PD-1/L1 inhibitors can be enrolled if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease. * Major surgical procedures or serious trauma within 4 weeks prior to randomization or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization. * History of coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization * Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy * History of serious cardiovascular, gastronintestinal, thromboembolic, neurological, or pulmonary conditions before randomization. * History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization

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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.

Non-small cell lung cancer

How to take part

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

  1. The places running it

    26 sites in 8 countries. 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

  • Academisch Ziekenhuis Maastricht

    Maastricht, Netherlands

  • Azienda Sanitaria Universitaria Friuli Centrale (Ospedaliero Universitario "Santa Maria della Misericordia" )

    Udine, 33100, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, Italy

  • CLCC-Jean Perrin

    Clermont-Ferrand, 63000, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.

    Athens, 151 23, Greece

  • Erasmuc Mc

    Rotterdam, Netherlands

  • General hospital of Athens 'Alexandra'

    Athens, 11528, Greece

  • Gustave Roussy

    Villejuif, t 94805, France

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Institut Godinot

    Reims, 51056, France

  • Kepler University Hospital

    Linz, 4021, Austria

  • Medical University of Vienna

    Vienna, 1090, Austria

  • Metropolitan Hospital

    Athens, Greece

  • Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola

    Roma, 00186, Italy

  • Policlinico Universitario Campus Bio-Medico- Oncology Center

    Roma, 00128, Italy

  • RCCS Ospedale San Raffaele

    Milan, Italy

  • The Institute Of Oncology

    Ljubljana, 1000, Slovenia

  • UMC-Academisch Ziekenhuis Utrecht

    Utrecht, Netherlands

  • Univ. Rostock-Zentrum für Radiologie mit Klinik und Poliklinik für Strahlentherapi

    Rostock, 18058, Germany

  • Universitaetsklinikum Jena

    Jena, 07447, Germany

  • University Clinic Golnik

    Golnik, 4204, Slovenia

  • University Hospital Frankfurt -Senckenberg Institute of Neurooncology

    Frankfurt am Main, 60590, Germany

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