RecruitingEarly Phase 1NCT07689643

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

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

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

36 participants

Start Date

Apr 28, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic Non Small Cell Lung Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called [177Lu]Lu-RTX-2358 for people with metastatic non small cell lung cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[177Lu]Lu-RTX-2358

\[177Lu\]Lu-RTX-2358 is a lutetium-177-labeled fibroblast activation protein (FAP)-targeted radioligand administered by intravenous infusion. Participants will receive one or two treatment cycles of approximately 7.4 GBq (200 mCi) per administration, depending on cohort assignment. A dosimetry cohort may receive a single low-dose administration (approximately 0.74 GBq, one-tenth of the therapeutic dose) followed by serial SPECT/CT imaging to evaluate biodistribution and radiation dosimetry before therapeutic administration.A commercially approved programmed cell death protein 1 (PD-1) inhibitor will be administered according to the approved prescribing information and institutional standard of care. Treatment will begin approximately 14 days after the first administration of \[177Lu\]Lu-RTX-2358 and will continue every 3 weeks until disease progression, unacceptable toxicity, or treatment discontinuation. The selected PD-1 inhibitor will remain unchanged throughout the combination treatmen