Phase 2 Rare Disease Trial, Recruiting NCT06563999 Sponsor: Sun Yat-sen University Condition: Rare Disease
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Phase 2 Rare Disease Trial, Recruiting

NCT06563999
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 have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be removed by surgery and is classified as stage III (using standard staging guidelines).
  • Your lung cancer is either of the "squamous" or "non-squamous" type (these refer to how the cancer cells look under a microscope).
  • Your cancer has been found to have one of these specific genetic changes: EGFR exon 20 insertion, ROS1 fusion, RET fusion, NTRK fusion, MET exon 14, HER2, BRAF V600E, KRAS G12C, or ALK fusion (identified through a genetic test called NGS).
  • Your cancer does NOT have two specific common genetic changes known as EGFR exon 19 deletion or EGFR exon 21 L858R mutation.
  • You are between 18 and 75 years old (male or female).
  • You are able to provide blood and tissue samples before and after treatment.
  • You are generally well enough to carry out daily activities with little or no limitation (confirmed by a standard health scoring system).
  • Your blood cell counts are at healthy enough levels (your doctor will check this with a blood test).
  • Your liver is functioning well enough (confirmed through blood tests).
  • Your kidneys are functioning well enough (confirmed through blood tests).
  • You have not previously received any treatment for your lung cancer.
  • You are not currently pregnant or breastfeeding.
  • You are willing and able to follow the trial schedule, attend appointments, and complete all required procedures.
  • You have read and signed a consent form agreeing to take part.

Who may not be able to join:

  • Your doctor does not consider your cancer to be unresectable (unable to be removed by surgery) stage III disease.
  • Your cancer has the specific EGFR genetic changes known as "sensitive mutations" (such as exon 19 deletion or exon 21 L858R).
  • You have already had any systemic treatment (such as chemotherapy or targeted therapy) for your lung cancer.
  • You currently have untreated or ongoing eye inflammation or eye infection, or a condition that makes you more likely to develop these.
  • You have been diagnosed with another cancer within the last 5 years — though some exceptions may apply, such as certain skin cancers or cervical cancer in situ that were fully cured (confirm with trial site).
  • You have active interstitial lung disease (a condition causing inflammation or scarring in the lungs).
  • You are known to be HIV positive or have AIDS.
  • You are unable or unwilling to follow the trial's procedures and requirements.
  • You have an unstable or serious ongoing health condition, such as uncontrolled high blood pressure, heart failure, a heart attack within the past year, serious heart rhythm problems, active infection, active tuberculosis, or serious liver, kidney, or metabolic disease.
  • You have another serious health condition that, in your doctor's opinion, could affect your ability to complete the trial or affect the results.
  • You are currently pregnant or breastfeeding.
  • Your cancer contains a mix of non-small cell and small cell lung cancer (confirm with trial site).

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 27 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: Si-Yu Wang, MD, Sun Yat-Sen University Cancer Center

Phone: +86 20 87343439

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
1 November 2024
Est. completion
1 November 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Resectability 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: 27 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