Phase 2 Brain Cancer Trial, Recruiting NCT06243003 Sponsor: Fudan University Condition: Brain Cancer
Back to Brain Cancer

Phase 2 Brain Cancer Trial, Recruiting

NCT06243003
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People whose general physical functioning is rated as reasonably good by their doctor (on a standard scale used in cancer care, scored 0–2)
  • People who have been diagnosed with small cell lung cancer, confirmed through a tissue or cell sample
  • People who have had a full set of baseline scans completed before starting any first-line treatment, including brain scans, full-body imaging, and other relevant imaging
  • People newly diagnosed with extensive-stage small cell lung cancer that has spread to the brain, who are planned to receive at least 4 cycles of standard chemotherapy (platinum-based, two-drug combination) together with immunotherapy (a PD-1 or PD-L1 antibody treatment) as their first treatment, and whose organ function meets the trial requirements as assessed by the doctor
  • People whose brain metastases meet specific criteria for a targeted radiation treatment called stereotactic radiosurgery (SRS) — this means no more than 10 brain tumours, each tumour smaller than 3 cm across and under 10 ml in volume, total tumour volume under 15 ml, and no spread to the lining of the brain
  • People with no history of other cancers
  • Men and women of childbearing age who agree to use contraception during the trial (such as surgical sterilisation, oral contraceptives, an intrauterine device, or condoms)
  • People with a life expectancy of at least 3 months
  • People who are able to understand and willingly sign a consent form

Who may not be able to join:

  • People whose pathology results show any non-small cell lung cancer component alongside their small cell lung cancer
  • People who have already received any cancer treatment before being diagnosed with extensive-stage small cell lung cancer
  • People whose scans show cancer has spread to the lining of the brain, or who have symptoms suggesting this
  • People who are unable to have a contrast-enhanced MRI scan
  • People whose brain metastasis symptoms are severe enough to require emergency surgery to relieve pressure in the brain
  • People who are unable to stay still as required for radiation treatment, or who cannot tolerate radiation therapy for any reason
  • People with significant active lung disease, such as interstitial lung disease or pneumonia (infectious or non-infectious)
  • People who require long-term use of corticosteroids or other immune-suppressing medications
  • People who have had an allergic reaction to PD-1 or PD-L1 immunotherapy, or who cannot receive immune maintenance therapy for any other reason
  • Women who are pregnant or breastfeeding
  • People with serious active autoimmune diseases, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, lupus, or autoimmune blood vessel conditions
  • People with other medical findings or uncontrolled conditions that the investigator believes could interfere with trial results or increase the risk of treatment complications
  • People with mental illness, substance use issues, or social circumstances that a doctor determines may affect their ability to follow the trial requirements

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +8618017312901

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
15 January 2024
Est. completion
1 July 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

dose-limiting toxicities rate; 1-year intracranial progression-free survival rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov