Can zapping brain tumors boost immunotherapy against lung cancer?
NCT ID NCT06501378
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing whether adding brain radiotherapy to PD-1/PD-L1 inhibitors and chemotherapy helps people with untreated stage IV non-small cell lung cancer that has spread to the brain. The trial enrolls about 40 adults whose tumors lack common driver mutations and whose brain metastases are active despite symptom treatment. Participants receive immune checkpoint inhibitors, chemotherapy, and either stereotactic radiotherapy or whole brain radiation, depending on their brain lesions. The main goal is to see how long patients live overall, with secondary measures tracking tumor response and brain progression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1/PD-L1 immune checkpoint inhibitors combined with chemotherapy and brain radiotherapy (stereotactic radiotherapy or whole brain radiation therapy)
- What this could lead to
- If it works, this could offer a clearer treatment path for people whose lung cancer has spread to the brain, a group often left out of immunotherapy trials.
- What could go wrong
- The trial is small and early-stage, so results may not hold up in larger studies. Combining radiation, immunotherapy, and chemotherapy can also cause side effects, and some tumors may resist the treatment.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Sep 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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; * KPS score ≥ 70; * Negative genetic testing for common driver genes including EGFR, ALK, ROS-1; * Pathologically confirmed non-small cell lung cancer; * Clinical stage IV (AJCC, 8th edition, 2017); * Diagnosed with brain metastasis at the time of diagnosis, with at least one lesion in the brain with a diameter greater than 5mm on thin-section brain MRI; * Active BMs that could not be controlled by symptomatic treatment, such as mannitol and dexamethasone * Complete baseline assessment of systemic lesions before treatment, including enhanced brain MRI; * Informed consent from the patient. Exclusion Criteria: * Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years); * Severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.; * Patients judged by the researcher as unsuitable for brain MRI or stereotactic brain radiotherapy; * EGFR, ALK, or ROS1 gene mutations; * Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance; * Symptomatic interstitial lung disease or active infection/non-infectious pneumonia; * Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation; * Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmia; * Other uncontrollable diseases or findings from physical examination or clinical experiments judged by the researcher to potentially interfere with the results or increase the risk of treatment complications for the patient; * Mixed with small cell lung cancer components; * Pregnant or lactating women; * Congenital or acquired immunodeficiency diseases including HIV, or history of organ transplantation, allogeneic stem cell transplantation; * Known HBV, HCV, active pulmonary tuberculosis infection; * Patients who have received tumor vaccines, or have been vaccinated with other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed, while nasal preparations are usually attenuated live vaccines and are not allowed); * Concurrent use of other immunomodulators, chemotherapy drugs, drugs in other clinical studies, and long-term use of corticosteroid treatment are not eligible for inclusion; * Patients allergic or contraindicated to PD-1/PD-L1 inhibitors or chemotherapy drugs.
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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.
Contacts and locations
Locations
-
Fudan University Shanghai Cancer Center
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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