Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to participate and able to sign a consent form agreeing to take part in the study
• You are between 18 and 75 years old (male or female)
• You have been newly diagnosed (never treated before) with a type of lung cancer called non-small cell lung cancer (NSCLC) that can be removed by surgery, and it is classified as stage II, IIIA, or IIIB based on scans or tissue samples
• You have had a PET-CT scan, or a CT scan plus an MRI, before joining the study
• Your lung cancer has a specific gene change called a HER2 mutation, confirmed by a tissue sample
• Your cancer has at least one area that can be measured on a scan, following standard measurement guidelines
• You can provide a tissue sample from your tumor (taken recently or within the last 3 months) and a blood sample for testing
• Your general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (confirm with trial site for exact definition)
• You have no medical reasons that would prevent you from receiving immunotherapy
• Your liver, kidneys, and other organs are working well enough to safely take part (confirm with trial site for specific test requirements)
• You are willing and able to attend all scheduled appointments, treatments, and tests required by the study
• Your lung function is good enough to safely undergo planned surgery, as assessed by a surgeon
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 3 days before your first dose; both women who could become pregnant and men whose partners could become pregnant must agree to use highly effective contraception during the study and for 180 days after the last dose

Who may not be able to join:

• Your cancer has spread to other parts of the body or cannot be removed by surgery
• Your lung cancer has certain other specific gene changes, including EGFR, ALK, KRAS, BRAF V600E, ROS1, RET, MET, or NTRK mutations or fusions
• You have previously received any systemic (whole-body) cancer treatment for early-stage NSCLC, including experimental treatments
• You have a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that required steroid treatment, or you currently have this condition
• You have active tuberculosis
• You currently have an active infection that requires treatment with medicines given throughout your body (such as antibiotics taken by mouth or into a vein)
• You have a known or suspected condition where your immune system attacks your own body (autoimmune disorder) or a condition that weakens your immune system — with some exceptions such as well-controlled thyroid conditions or controlled type 1 diabetes (confirm with trial site)
• You have active, uncontrolled hepatitis B or active hepatitis C infection (some exceptions may apply for hepatitis B if it is being treated — confirm with trial site)
• You are known to be HIV positive
• You have received a live vaccine (such as for measles, chickenpox, yellow fever, or BCG) within 30 days before your first dose
• You have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, CTLA-4, or similar immune pathways
• You have had a severe allergic reaction to another monoclonal antibody (a type of targeted medicine)
• You have a serious or uncontrolled existing medical condition, such as an unstable heart condition, a recent stroke, or significant liver disease, within the past 6 months
• You have been diagnosed with another cancer in the past 5 years — with some exceptions for certain low-risk cancers that have been fully treated (confirm with trial site)

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