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Tests treatment safety and results for Metastatic Non-small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07689643
What this study is testing
What is [177Lu]Lu-RTX-2358?
[177Lu]Lu-RTX-2358 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic non-small cell lung cancer.
Also referred to as PD-1 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- At least one measurable lesion per RECIST version 1.1 criteria.
You likely can't join if
- History of another active malignancy requiring treatment within 2 years before the first administration of [177Lu]Lu-RTX-2358, except adequately...
- Symptomatic brain metastases or central nervous system metastases requiring active treatment. Participants with previously treated brain metastases...
- Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.
- Major surgery, open biopsy (excluding needle biopsy), or significant traumatic injury within 4 weeks before the first administration of...
- Receipt of systemic anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, biologic therapy, investigational agents, or...
- Receipt of curative radiotherapy within 6 weeks before the first administration of [177Lu]Lu-RTX-2358. Palliative radiotherapy is permitted if...
See the full 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.
- At least one measurable lesion per RECIST version 1.1 criteria.
- ECOG performance status 0 or 1.
- Estimated life expectancy ≥ 3 months.
- Adequate bone marrow, hepatic, renal, and coagulation function.
- Willing to comply with all radiation protection requirements throughout study participation.
- Willing to use highly effective contraception during study treatment and post-treatment follow-up period.
- History of another active malignancy requiring treatment within 2 years before the first administration of [177Lu]Lu-RTX-2358, except adequately treated basal cell carcinoma of the skin or carcinoma in situ treated with...
- 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...
- Symptomatic spinal cord compression or radiographic evidence of impending spinal cord compression.
- Major surgery, open biopsy (excluding needle biopsy), or significant traumatic injury within 4 weeks before the first administration of [177Lu]Lu-RTX-2358. Prior treatment with any radioligand therapy or therapeutic...
- 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...
- Receipt of curative radiotherapy within 6 weeks before the first administration of [177Lu]Lu-RTX-2358. Palliative radiotherapy is permitted if completed at least 2 weeks before treatment, involves less than 10% of bone...
- Unresolved toxicities from previous anticancer therapy greater than Grade 1 according to NCI CTCAE version 5.0, except stable chronic toxicities judged by the investigator not to pose a safety risk (e.g., alopecia...
- Endocrine dysfunction involving the thyroid, adrenal, pituitary, or pancreas that would preclude treatment with immune checkpoint inhibitors. Known interstitial lung disease, immune-related pneumonitis, pulmonary...
- Severe urinary incontinence, hydronephrosis, bladder outlet obstruction, or other clinically significant urinary tract disorders that may interfere with radiopharmaceutical clearance.
- Clinically significant cardiovascular disease, including myocarditis, pericarditis, myocardial infarction, unstable angina, New York Heart Association Class III or IV heart failure, uncontrolled arrhythmias...
- Active uncontrolled infection, including human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, active syphilis, or any infection requiring systemic therapy that is not adequately...
- Severe psychiatric illness or any medical condition that, in the investigator's judgment, would compromise participant safety, interfere with study participation, or affect protocol compliance.
- Pregnant or breastfeeding women.
- Known hypersensitivity to [177Lu]Lu-RTX-2358 or any of its components. History of significant occupational exposure to ionizing radiation exceeding applicable regulatory limits.
- Participation in another treatment clinical trial within 4 weeks before screening.
- Inability or unwillingness to undergo required study procedures, including PET/CT, SPECT/CT, CT/MRI examinations, or inability to comply with protocol requirements.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.