OncoMatch/Clinical Trials/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
Is NCT07689643 recruiting? Yes, currently enrolling (Jul 2026). This Early Phase 1 trial studies [177Lu]Lu-RTX-2358 for metastatic non-small cell lung cancer.
Treatment: [177Lu]Lu-RTX-2358 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: FAP imaging positivity
FAP-positive disease demonstrated by FAPI PET imaging
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radioligand therapy
Prior treatment with any radioligand therapy or therapeutic radiopharmaceutical
Lab requirements
Blood counts
adequate bone marrow function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Adequate bone marrow, hepatic, renal, and coagulation function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07689643 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radioligand therapy disqualifies patients from enrollment.
Does this trial require FAP?
Yes, FAP imaging positivity is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages