Phase 2 Lung Cancer Trial, Recruiting NCT06440954 Sponsor: Hunan Province Tumor Hospital Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06440954
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 aged 18 or older
  • People who have been diagnosed with metastatic non-small cell lung cancer that has spread to the membranes surrounding the brain or spinal cord (called leptomeningeal metastasis), confirmed by tissue or cell testing, and whose cancer has stopped responding to TKI (targeted therapy) treatment
  • People whose cancer has a specific genetic change confirmed by an accredited lab — this includes EGFR mutation, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NTRK fusion, or KRAS mutation
  • People whose blood counts and organ function (such as liver and kidneys) are at an adequate level
  • People who agree to receive a chemotherapy drug called pemetrexed delivered directly into the spinal fluid (intrathecal injection)
  • People with a general health/activity level rated as ECOG 0, 1, or 2 — meaning they are able to carry out at least some daily activities (confirm with trial site)
  • People whose doctors expect them to survive for at least 12 weeks

Who may not be able to join:

  • People who have previously received pemetrexed delivered into the spinal fluid (intrathecal pemetrexed)
  • People who have had radiation therapy within 14 days before starting the trial, or who are still experiencing side effects from radiation — though some specific types of radiotherapy (chest, palliative, or stereotactic) may be allowed if completed at least 7 days before starting (confirm with trial site)
  • People who have spinal cord compression or meningeal metastasis of a type that would exclude them (confirm with trial site for clarification)
  • People who have had another cancer within the past 2 years
  • People still experiencing side effects (other than hair loss) from previous treatments such as chemotherapy or radiotherapy, rated above a mild level
  • People who have had a stroke or bleeding in the brain within the 6 months before starting the trial
  • People with severe or poorly controlled conditions such as uncontrolled high blood pressure or active bleeding
  • People with ongoing or active infections, including hepatitis B, hepatitis C, HIV, or COVID-19
  • People with certain heart-related diseases or abnormalities (confirm with trial site for full details)
  • People with a history of certain lung conditions, including interstitial lung disease, radiation-related lung inflammation requiring steroid treatment, or immune-related lung inflammation from immunotherapy
  • People who have severe ongoing nausea and vomiting, chronic gut disease, difficulty swallowing tablets, or poor absorption of medication due to previous bowel surgery — specifically affecting the study drugs sunvozertinib or anlotinib
  • People who have received a live vaccine within 2 weeks before starting the trial
  • People who are pregnant or breastfeeding
  • People who are known to be allergic to any of the study drugs or their ingredients
  • People whom the trial investigators consider unsuitable for other reasons

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.

Contact this trial

Principal Investigator: Yongchang Zhang, Hunan Cancer Hospital

Phone: 13873123436

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
Sponsor
Hunan Province Tumor Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Intracranial progression-free survival (I-PFS)

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