Lung Cancer (Non-Small Cell)Phase 2NCT07841106
Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases
A Phase 2 study testing Recombinant Human Endostatin (Endostar) in people with Lung Cancer (Non-Small Cell) and Radiation, run by Jiangmen Central Hospital.
Trial summary
Primary Purpose:To preliminarily evaluate the efficacy and safety of recombinant human endostatin (Endostar) in the early prophylactic cohort (Cohort A) and late salvage cohort (Cohort B) for radiation-induced brain injury after stereotactic radiosurgery (SRS) in patients with non-small cell lung cancer (NSCLC) brain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (Non-Small Cell), Radiation, Brain Injury
- What is being tested?
- Recombinant Human Endostatin (Endostar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky performance status (KPS) score ≥60.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Baseline contrast-enhanced brain MRI confirms 1-15 brain metastases, with a total volume of all lesions <15 mL, and the largest lesion with a maximum diameter ≤4.0 cm or volume ≤10 mL.
- Cohort A: Planned to receive SRS, and baseline MRI shows significant peritumoral edema (edema index >2), where EI = (tumor volume + edema volume) / tumor volume. Cohort B: Radiographic (MRI) evidence of radiation-induced brain edema/necrosis after SRS (usually ≥3 months after SRS).
- Prior or concurrent radiotherapy for extracranial lesions is allowed. Prior TKI, chemotherapy, or immunotherapy is allowed. After enrollment, systemic therapy may be continued or adjusted according to clinical need.
- Within 14 days before study treatment, bone marrow and major organ function must meet the following criteria: ANC ≥1.5×10^9/L; platelets ≥100×10^9/L; hemoglobin ≥90 g/L; total bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; serum creatinine ≤1.5×ULN or CrCl ≥45 mL/min; INR ≤1.5; APTT ≤1.5×ULN; urine protein <2+; if urine protein ≥2+, 24-hour urine protein <2 g.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment. All patients of reproductive potential must agree to use highly effective contraception during the study and for 6 months after the last dose.
- Patients voluntarily participate, have signed the written informed consent form (ICF), and are expected to comply with and follow all study requirements.
Who cannot join
- Known allergy to Endostar or any of its excipients.
- Received any other anti-angiogenic therapy within 4 weeks before the first dose.
- Uncontrolled hypertension despite medication (SBP >150 mmHg and/or DBP >100 mmHg).
- History of major bleeding (e.g., hemoptysis, gastrointestinal bleeding) or current active bleeding, bleeding tendency, or coagulation disorder.
- History of arterial thromboembolic events (e.g., MI, unstable angina, CVA, or TIA) within 6 months before the first dose.
- Symptomatic CHF (NYHA Class ≥ II) or severe arrhythmia requiring treatment.
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- Severe hepatic/renal insufficiency: total bilirubin >1.5×ULN; or ALT/AST >2.5×ULN; or serum creatinine >1.5×ULN and CrCl <45 mL/min.
- Urine protein ≥++, or 24-hour urine protein ≥2.0 g.
- History of gastrointestinal perforation, active gastrointestinal bleeding, intra-abdominal abscess, or active IBD.
- Symptomatic uncontrolled brain metastasis hemorrhage or obvious intracranial hypertension crisis, as judged by the investigator.
- Contraindications to MRI.
- Pregnant or lactating women.
- Any severe acute/chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase risk, interfere with results, or affect the investigator's judgment of the patient's ability to complete the study.
- Poor compliance, and the patient is not expected to complete all necessary treatment and follow-up assessments.
About this study
Primary Purpose:To preliminarily evaluate the efficacy and safety of recombinant human endostatin (Endostar) in the early prophylactic cohort (Cohort A) and late salvage cohort (Cohort B) for radiation-induced brain injury after stereotactic radiosurgery (SRS) in patients with non-small cell lung cancer (NSCLC) brain metastases, with a focus on the improvement rate of peritumoral brain edema.Secondary Purpose:To explore the effects of Endostar treatment on neurological function, quality of life, and survival outcomes in patients with NSCLC brain metastases following SRS; and to evaluate the convenience and compliance of the "72-hour continuous intravenous pump infusion" regimen.
- Being tested
- Recombinant Human Endostatin (Endostar)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Injuries, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Endostatin (Endostar)Drug
Dosage Regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days).
Treatment Cycle: Every 3 weeks (21 days) constitutes one cycle, for a total of 4 cycles.
Route of Administration: Intravenous infusion (continuous pump infusion). Treatment Timing: Cohort A (early prevention cohort): The first cycle should be initiated within 14 days after stereotactic radiosurgery (SRS).
Total Treatment Duration: Approximately 12 weeks (4 cycles, 21 days per cycle).
Recombinant Human Endostatin (Endostar)Drug
Dosage regimen: Endostar 210 mg, diluted with normal saline to a total volume, administered via continuous intravenous pump infusion over 72 hours (3 days).
Treatment cycle: One cycle every 3 weeks (21 days), for a total of 4 cycles. Route of administration: Intravenous infusion (continuous pump infusion). Timing of treatment: Cohort B (late salvage cohort): initiate the first cycle of treatment within 14 days after confirmed diagnosis of radiation-induced brain edema/necrosis (usually ≥3 months after SRS).
Total duration of treatment: Approximately 12 weeks (4 cycles, 21 days per cycle).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Early Prophylaxis) | Experimental | Inclusion of 23 subjects. Receives: Drug: Recombinant Human Endostatin (Endostar) |
| Cohort B (Late Salvage Cohort) | Experimental | Inclusion of 26 subjects. Receives: Drug: Recombinant Human Endostatin (Endostar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Analyzed by the Kaplan-Meier method. OS is defined as the time from enrollment to death from any cause. Surviving patients are censored at last follow-up.
Measured: From enrollment to death from any cause, assessed up to 60 months.
Secondary outcomes (5)
Change in Quality of Life Score Assessed by the EORTC QLQ-BN20
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Brain Cancer Module (EORTC QLQ-BN20). The QLQ-BN20 contains 20 items, and scores are linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden/worse outcome. Changes in scores from baseline to post-treatment are analyzed.
Measured: Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).
Incidence and Severity of Adverse Events
All adverse events are graded and recorded according to NCI CTCAE v5.0. The incidence, severity, and causal relationship to the study drug are summarized.
Measured: From informed consent form (ICF) signing until 4 weeks after the last dose of study drug; assessed before each treatment cycle (each cycle is XX days), with summary at 4 weeks after the last dose.
Intracranial Progression-Free Survival (iPFS)
Analyzed by the Kaplan-Meier method. Intracranial progression is defined per RANO-BM criteria on contrast-enhanced T1-weighted brain MRI. Imaging assessments are performed every 2-3 months (each treatment cycle is 21 days).
Measured: From enrollment until the date of first documented intracranial progression per RANO-BM or death from any cause, whichever came first, assessed up to 60 months; imaging assessments every 2-3 months.
Brain edema improvement rate
Edema volume around target lesions is measured on T2/FLAIR sequences of brain MRI at baseline and post-treatment. Brain edema improvement is defined as a ≥25% reduction in edema volume from baseline. The response rate is calculated as: (number of patients with ≥25% reduction in edema volume / total number of evaluable patients) × 100%.
Measured: At Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days), i.e., the end-of-treatment assessment visit.
Neurological Function Improvement Rate Assessed by Focused Neurological Examination
Neurological function is assessed by focused neurological examination, including cranial nerve, motor, sensory, cerebellar, and reflex evaluations. Improvement is defined as resolution or stabilization of neurological deficits. The improvement rate is calculated as: (number of patients with improvement / total number of evaluable patients) × 100%.
Measured: Baseline and Week 4 post-treatment (4 weeks ± 7 days after the 4th treatment cycle; each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Non-Small Cell)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study plans to enroll a total of 49 subjects, with 23 assigned to Cohort A (early prevention cohort) and 26 to Cohort B (late salvage cohort).
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangmen Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Xiao, Jiangmen Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841106
- Sponsor's protocol ID
- 2026YL01060
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No