This is a prospective, single-center, open-label investigator-initiated study designed to evaluate the safety, tolerability, radiation dosimetry, biodistribution, and preliminary antitumor activity of \[177Lu\]Lu-RTX-2358 in combination with immune checkpoint inhibitors (ICIs) in patients with fibroblast activation protein (FAP)-positive metastatic non-small cell lung cancer (NSCLC). Eligible participants will receive one or two cycles of \[177Lu\]Lu-RTX-2358 followed by standard PD-1 inhibitor therapy. Safety, tumor response, biodistribution, radiation dosimetry, and survival outcomes will be evaluated throughout treatment and follow-up.
Written informed consent must be obtained prior to any study-related procedures.
Age ≥ 18 years old.
Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC).
FAP-positive lesions confirmed by FAPI PET imaging.
History of another active malignancy requiring treatment within 2 years before the first administration of [177Lu]Lu-RTX-2358, except adequately treated basal cell carcinoma of the skin or carcinoma in situ treated with curative intent.
Symptomatic brain metastases or central nervous system metastases requiring active treatment. Participants with previously treated brain metastases are eligible if the disease has remained clinically and radiographically stable for at least 24 weeks.
Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.
Major surgery, open biopsy (excluding needle biopsy), or significant traumatic injury within 4 weeks before the first administration of [177Lu]Lu-RTX-2358.