NCT05256290

Who might be able to join this trial:

• Your cancer has been confirmed as non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body, and it has not transformed into a different type called small cell lung cancer.
• Your tumors can be measured using standard imaging scans.
• Your blood counts and organ function (such as liver and kidneys) are at an acceptable level.
• Doctors expect you to live for at least 3 more months.
• You are well enough to take part in the study (confirm with trial site for specific fitness requirements).
• You have a specific type of gene change (mutation) in a gene called EGFR, confirmed by a detailed genetic test called Next Generation Sequencing (NGS) — this includes certain uncommon ("non-classical") EGFR mutations or a resistance mutation called C797S.
• You may be eligible under one of three specific groups:
  • Group 1: You have an uncommon EGFR mutation and have had up to 2 previous treatments, including one targeted therapy drug called an EGFR TKI.
  • Group 2: Your cancer developed a resistance mutation called C797S after treatment with a third-generation EGFR TKI (such as osimertinib), and you have had up to 2 previous treatments.
  • Group 3: You have not yet had treatment for your advanced NSCLC (though one cycle of chemotherapy or immunotherapy is allowed), and you have an uncommon EGFR mutation.
• Brain metastases (cancer that has spread to the brain) are allowed, as long as they are not causing serious symptoms requiring urgent treatment.

Who may not be able to join:

• Your genetic test shows certain resistance mutations (such as T790M or MET changes) in your tumor or blood sample.
• You have previously received more than one type of EGFR TKI targeted therapy drug (such as erlotinib or gefitinib).
• You have ever had a serious lung condition called interstitial lung disease caused by an EGFR TKI drug.
• You have cancer that has spread to the lining around the brain or spinal cord and is causing symptoms or showing up on scans (leptomeningeal disease).
• You have brain metastases or spinal cord compression that is causing serious symptoms and needs urgent treatment.
• You still have side effects from a previous cancer treatment that have not fully resolved.
• You have a significant heart or blood vessel condition.
• You have had major surgery within the last 4 weeks before joining, or you are planning major surgery during the study.
• You are currently receiving or have recently received other cancer treatments or radiation therapy.
• You have another active cancer (other than the one being studied) that will need treatment within the next 2 years.
• You have an active hepatitis B or hepatitis C infection, or you are known to carry HIV.
• You have poorly controlled digestive or stomach/bowel problems.

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