Phase 2 Brain Cancer Trial, Recruiting NCT06501378 Sponsor: Fudan University Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT06501378
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:

  • Adults aged 18 or older
  • People whose general health and ability to carry out daily activities meets a minimum threshold, as measured by a standard medical scoring tool called the Karnofsky Performance Scale (score of 70 or above) (confirm with trial site)
  • People whose lung cancer has been confirmed by laboratory testing of tissue samples to be non-small cell lung cancer
  • People whose cancer is at stage IV (the most advanced stage), according to a standard staging system from 2017
  • People who do not have specific gene changes (called EGFR, ALK, or ROS-1 mutations) in their cancer cells, confirmed by genetic testing
  • People who have cancer that has spread to the brain at the time of first diagnosis, with at least one brain tumour spot larger than 5mm, seen on a detailed MRI brain scan
  • People whose brain tumours are still active and not responding well to standard symptom-relief treatments such as mannitol or dexamethasone (steroids)
  • People who have had a full assessment of all cancer sites in the body before starting treatment, including a detailed MRI brain scan with contrast dye
  • People who have given written informed consent to participate

Who may not be able to join:

  • People who have more than one primary cancer or other metastatic cancers (with exceptions for certain skin cancers or cervical pre-cancers that were fully treated more than 5 years ago with no return)
  • People with serious autoimmune diseases, such as active inflammatory bowel disease (including Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, lupus, or autoimmune blood vessel diseases
  • People who the trial doctor judges to be unsuitable for brain MRI scans or a type of targeted brain radiation treatment called stereotactic radiotherapy
  • People whose cancer cells carry EGFR, ALK, or ROS1 gene mutations
  • People with uncontrolled epilepsy, nervous system diseases, or a history of mental health conditions that the trial doctor believes could affect their ability to consent or follow the trial requirements
  • People with active or symptomatic lung disease affecting the lung tissue (interstitial lung disease) or active lung infections or inflammation
  • People with conditions that increase the risk of a hole forming in the intestine, such as active diverticulitis, an abscess in the abdomen, a bowel blockage, or abdominal cancer
  • People with an active serious infection, heart failure, a heart attack within the past 6 months, unstable chest pain (angina), or an unstable irregular heartbeat
  • People with other serious uncontrolled health conditions that the trial doctor believes could affect the trial results or increase the risks of treatment
  • People whose lung cancer has a mixed small cell lung cancer component
  • People who are pregnant or breastfeeding
  • People with immune system deficiencies present from birth or acquired (including HIV), or who have had an organ transplant or stem cell transplant from a donor
  • People with known active hepatitis B, hepatitis C, or active tuberculosis infection
  • People who have previously received a cancer vaccine, or who have received any other vaccine (except certain inactivated seasonal flu vaccines) within 4 weeks before starting the trial
  • People currently using other immune-modifying drugs, chemotherapy, drugs from other clinical trials, or long-term steroid treatment
  • People who are allergic to or otherwise unable to receive PD-1/PD-L1 immunotherapy drugs or chemotherapy drugs

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 13 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.

GP referral letter

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Trial details

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

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall survival (OS)

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: 13 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