A Single-Center, Prospective, Open-Label, Investigator-Initiated Study Evaluating the Safety, Biodistribution, Radiation Dosimetry, and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung Cancer
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.
• At least one measurable lesion per RECIST version 1.1 criteria.
• ECOG performance status 0 or 1.
• Estimated life expectancy ≥ 3 months.
• Adequate bone marrow, hepatic, renal, and coagulation function.
• Willing to comply with all radiation protection requirements throughout study participation.
• Willing to use highly effective contraception during study treatment and post-treatment follow-up period.