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

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

Trial Details

NCT ID
NCT07689643
Phase
EARLY_PHASE1
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • [177Lu]Lu-RTX-2358
Locations (sample)
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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