New combo attack on lung cancer brain metastases shows promise in Real-World study
NCT ID NCT07491211
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at using a targeted drug called osimertinib together with precise brain radiation as the first treatment for people with a certain type of lung cancer (EGFR-mutant) that has spread to the brain and causes symptoms. Researchers reviewed medical records of 300 patients from multiple hospitals to see how well this combination works and how safe it is. The goal is to find a better way to control both the lung cancer and brain tumors from the start.
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 intracranial stereotactic radiotherapy (precise radiation to brain tumors)
- What this could lead to
- If successful, this combination could become a standard first treatment for people with EGFR-mutant lung cancer that has spread to the brain, potentially improving control of brain tumors and extending survival.
- What could go wrong
- This is a retrospective study, not a controlled trial, so results may be less reliable. The treatment involves radiation to the brain, which carries risks like swelling or tissue damage. It is also only for patients with a specific gene mutation.
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.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2019
- Expected to finish
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Mar 2026
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.
Who is studied
The study population will include Stage IV EGFR-mutant NSCLC patients with symptomatic brain metastases who were initially treated with first-line Osimertinib and upfront intracranial SRT during the enrollment period meeting the inclusion and exclusion criteria. First-line therapy must be initated within 6 weeks after initial diagnosis of stage IV EGFRm NSCLC. The patients will be collected across multiple centers in China.
- 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, Male or female * Pathologically confirmed Stage IV metastatic non-squamous non-small cell lung cancer (NSCLC) with documented positive EGFR sensitive mutation (EGFR 19del and L858R) and MRI confirmed brain metastases, diagnosed within 6 weeks prior to treatment initiation within baseline period * Received first-line osimertinib monotherapy during observation period * Upfront brain SRT during observation period * Baseline ECOG scored 0-2 * Symptomatic brain metastases during baseline period\* * Complete imaging evaluation of systemic lesions (including brain MRI) during baseline period and before osimertinib treatment * At least 1 follow-up brain MRI during observation period * Baseline BM: ≤10 Brain metastases, largest tumor \<10 mL in volume and \<3 cm in longest diameter; total cumulative volume ≤15 ml \*Symptomatic brain metastases are defined as any neurological symptom in relation to the diagnosed BM, occurred within 30 days after brain metastases diagnosis. Exclusion Criteria: * Leptomeningeal metastases at stage IV NSCLC diagnosis * Whole brain radiotherapy treated BM during observation period * Patients received other systemic anti-tumor therapy in addition to osimertinib as 1L treatment during observation period * Secondary or multiple primary tumors at stage IV NSCLC diagnosis * Patients received any adjuvant targeted therapy after previous surgery
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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
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Fudan University Shanghai Cancer Center
Shanghai, China, 200032, China
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Shanghai Jiao Tong University Affiliated Chest Hospital
Shanghai, China
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Wuhan Tongji Hospital
Wuhan, Hubei, China
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