New combo aims to treat brain metastases while protecting memory
NCT ID NCT07505173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a new way to treat lung cancer that has spread to the brain. It combines a targeted cancer pill (osimertinib) with a special type of whole-brain radiation that tries to protect the memory center (hippocampus). The study will enroll 74 people with a specific EGFR gene mutation. The goal is to see if this approach can keep brain tumors under control longer while causing fewer thinking and memory problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- osimertinib (a targeted cancer pill) and radiation therapy
- What this could lead to
- If successful, this combination could offer a safer, more effective way to control brain metastases while better preserving memory and thinking skills.
- What could go wrong
- This is a small, early-phase study (74 people) with no comparison group, so results may not be definitive. Radiation to the brain always carries risks like fatigue, hair loss, and potential cognitive 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
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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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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- 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 to 75 years
- 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: * Signed a written informed consent form prior to enrollment; * Aged 18-75 years; * Histopathologically confirmed non-small cell lung adenocarcinoma (NSCLC); EGFR gene test confirmed EGFR sensitive mutations, including exon 19 deletion (19del) and exon 21 L858R mutation (verified and confirmed by investigators at the respective study centers); * Brain metastasis confirmed by contrast-enhanced cranial CT/MRI; the number of brain metastatic lesions requiring local dose escalation is 1-10, with at least one measurable intracranial lesion having a diameter ≥10 mm; the distance between metastatic lesions and important cerebral functional areas meets radiotherapy-related requirements; at least one measurable lesion (per RECIST v1.1 criteria) confirmed by contrast-enhanced extracranial CT/PET-CT; * Symptomatic brain metastasis; * ECOG performance status score: 0-2; * Expected survival time of no less than 12 weeks; * No prior anti-tumor treatment received for NSCLC; * Normal function of vital organs, meeting the following requirements (no blood components or cell growth factors administered within 14 days): A) Routine blood test criteria: Hb ≥100 g/L; ANC ≥1.5×10⁹/L; PLT ≥75×10⁹/L; B) Biochemical test criteria: TBIL ≤1.5×ULN (upper limit of normal); ALT and AST ≤2.5×ULN (for patients with liver metastasis, ALT and AST ≤5×ULN); serum creatinine ≤1.5×ULN, creatinine clearance rate ≥50 ml/min (calculated based on the Cockroft-Gault formula); C) Coagulation function criteria: INR ≤1.5×ULN and APTT ≤1.5×ULN; D) Cardiac color Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%; \- For non-surgically sterilized patients or women of childbearing potential: a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment period and for 3 months after the end of study treatment; non-surgically sterilized women of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment, and must not be breastfeeding. All subjects voluntarily participate in the study, with good compliance and willingness to cooperate with safety and overall survival follow-up. Exclusion Criteria: * Presence of uncontrollable third space effusion (e.g., pleural effusion, ascites) that cannot be managed with drainage or other interventions; * Presence of multiple factors impairing oral drug administration and absorption (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.); * Patients who are known to be pregnant, planning pregnancy, or women of childbearing potential who refuse to adopt effective contraceptive measures throughout the study period; * Patients with severe concomitant diseases or those deemed ineligible for enrollment by the investigator; * Patients with meningeal metastasis; * Participation in other drug clinical trials within 4 weeks prior to enrollment; * Concurrent receipt of other anti-tumor therapies; * A known history of psychotropic drug abuse, alcoholism, or drug addiction in the subject; * Underlying diseases that may interfere with study drugs (e.g., clinically significant electrocardiographic abnormalities, active interstitial lung disease); * Any other conditions deemed by the investigator to potentially harm the subject or render them unable to meet or comply with the study requirements.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, China