Evaluation of Safety and Early Effects of 177LuLu-RTX-2358 Combined with Immune Checkpoint Inhibitors in Patients with FAP-Positive Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, radiation dosimetry, biodistribution, and early antitumor activity of 177LuLu-RTX-2358 combined with immune checkpoint inhibitors in patients with fibroblast activation protein FAP-positive metastatic non-small cell lung cancer NSCLC. This early phase 1, open-label study is conducted at a single center and aims to better understand treatment effects and safety in this population. Participants will receive one or two intravenous doses of 177LuLu-RTX-2358 at approximately 7.4 GBq per dose, depending on their assigned cohort. Some participants may first receive a low-dose administration for imaging and dosimetry evaluation. Approximately 14 days after the first dose, standard PD-1 inhibitor therapy begins and continues every 3 weeks until disease progression, unacceptable toxicity, or discontinuation. Treatment plans vary by cohort. During the study, participants will undergo tumor response assessments, safety monitoring for treatment-emergent adverse events, biodistribution studies, and radiation dosimetry evaluations. The primary outcome focuses on the incidence and severity of adverse events up to 30 days after treatment. Secondary outcomes include objective response rate and disease control rate assessed up to 12 months after treatment. Participants are followed throughout treatment and follow-up to evaluate survival and treatment effects.

Safety and Preliminary Efficacy of [177Lu]Lu-RTX-2358 Combined With Immune Checkpoint Inhibitors in Patients With FAP-positive Metastatic Non-Small Cell Lung Cancer