Clinical Trial · NCT07689643

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

Overview

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.

Sponsor

Norwegian University of Science and Technology

Phase

Early Phase 1

Contacts

Xiaoli Lan (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

ClinicalTrials.gov

NCT07689643

Drug / Compound

RTX-2358

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Eligibility

Inclusion

Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC).
At least one measurable lesion per RECIST version 1.1 criteria.

Exclusion

Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.
Receipt of systemic anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, biologic therapy, investigational agents, or antitumor traditional Chinese medicine, within 21 days before the first administration of \[177Lu\]Lu-RTX-2358, unless the protocol-defined washout period has been satisfied.
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.