Phase 2 Brain Cancer Trial, Recruiting NCT06501391 Sponsor: Fudan University Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT06501391
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:

  • You are 18 years of age or older
  • You have a reasonable level of general health and ability to carry out daily activities (based on a standard scoring system your doctor uses)
  • Genetic testing of your cancer has come back negative for certain specific gene changes (called EGFR, ALK, and ROS-1)
  • Your cancer has been confirmed by a tissue sample (biopsy) to be a type called non-small cell lung cancer
  • Your cancer is at stage 4 (the most advanced stage, meaning it has spread to other parts of the body)
  • Your cancer has already spread to the brain at the time of diagnosis, with at least one brain tumour measuring more than 5mm, as seen on a detailed brain scan (MRI)
  • You have had a full set of baseline scans before starting treatment, including a detailed brain MRI with contrast dye
  • You are willing and able to give your informed consent to take part in the trial

Who may not be able to join:

  • You have more than one type of cancer, or cancer that has spread from another source (with some exceptions for certain skin or cervical cancers fully treated more than 5 years ago with no return)
  • You have a serious autoimmune disease such as inflammatory bowel disease, rheumatoid arthritis, lupus, scleroderma, or autoimmune blood vessel disease
  • The trial doctor feels you are not suitable for a brain MRI scan or a precise type of brain radiation treatment called stereotactic radiotherapy
  • Your cancer has the specific gene changes EGFR, ALK, or ROS1
  • Your brain tumours are not responding to symptom-relief medications (such as mannitol or dexamethasone) and remain active and uncontrolled
  • You have uncontrolled epilepsy, a nervous system condition, or a history of mental health disorders that could affect your ability to consent or follow the trial requirements
  • You have an active lung condition involving inflammation of the lung tissue (interstitial lung disease) or an active lung infection
  • You have conditions that increase the risk of a hole developing in your bowel, such as diverticulitis, an abdominal abscess, a bowel blockage, or abdominal cancer
  • You have an active infection, heart failure, a heart attack within the last 6 months, unstable chest pain (angina), or an uncontrolled irregular heartbeat
  • You have another serious uncontrolled health condition that the trial doctor believes could interfere with the results or put you at greater risk
  • Your cancer contains a mix of small cell lung cancer cells alongside non-small cell lung cancer
  • You are pregnant or currently breastfeeding
  • You have an immune system condition from birth or acquired (such as HIV), or you have had an organ transplant or stem cell transplant
  • You have an active infection with Hepatitis B, Hepatitis C, or tuberculosis
  • You have received a cancer vaccine, or any other vaccine (except inactivated flu vaccines) within 4 weeks before starting the trial
  • You are currently taking other immune-system-affecting drugs, chemotherapy, drugs from another clinical trial, or long-term steroid medications
  • You are known to be allergic to or cannot take immunotherapy drugs (PD-1/PD-L1 inhibitors) or chemotherapy

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 16 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

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

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
1 July 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR)

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: 16 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