Metastatic Non-small Cell Lung CancerEarly 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 Early Phase 1 study testing [177Lu]Lu-RTX-2358 in people with Metastatic Non-small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- [177Lu]Lu-RTX-2358
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 curative intent.
- 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.
- 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 radiopharmaceutical.
- 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.
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- 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 marrow, and does not include target lesions.
- 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, peripheral neuropathy, or fatigue).
- 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 fibrosis, or active pulmonary fibrosis.
- 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, uncontrolled hypertension, or conditions associated with clinically significant QT interval prolongation within 6 months before enrollment.
- 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 controlled.
- Serious or non-healing wounds, active ulcers, or fractures requiring ongoing treatment.
- 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 interventional 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaoli Lan, 0086-027-83692633, lxl730724@hotmail.com
About this study
Official title: 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
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.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- [177Lu]Lu-RTX-2358
- Keywords
- Metastatic Non-Small Cell Lung Cancer, 177Lu, FAP, Radioligand Therapy, PD-1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-RTX-2358Drug
Also called PD-1 inhibitor
[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
| Study group | Role | What they receive |
|---|---|---|
| [177Lu]Lu-RTX-2358 plus Immune Checkpoint Inhibitor | Experimental | Participants will receive one or two intravenous administrations of [177Lu]Lu-RTX-2358 in combination with standard PD-1 inhibitor therapy. The treatment schedule depends on cohort assignment. Receives: Drug: [177Lu]Lu-RTX-2358 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of [177Lu]Lu-RTX-2358 in combination with a PD-1 inhibitor by assessing the incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs), graded according to NCI CTCAE version 5.0.
Measured: From the first administration of [177Lu]Lu-RTX-2358 until 30 days after the last administration of study treatment.
Secondary outcomes (2)
Objective Response Rate (ORR)
Objective response rate, defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: From baseline until disease progression, initiation of new anticancer therapy, death, or up to 12 months after the last study treatment, whichever occurs first.
Disease Control Rate (DCR)
Disease control rate, defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1.
Measured: Up to 12 months after the last study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start28 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689643
- Sponsor's protocol ID
- Xlan-20251245
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07689643
- Acronym / sponsor ID
- Xlan-20251245
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Keywords
- Metastatic Non-Small Cell Lung Cancer, 177Lu, FAP, Radioligand Therapy, PD-1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [177Lu]Lu-RTX-2358 plus Immune Checkpoint Inhibitor | Experimental | Drug: [177Lu]Lu-RTX-2358Participants will receive one or two intravenous administrations of [177Lu]Lu-RTX-2358 in combination with standard PD-1 inhibitor therapy. The treatment schedule depends on cohort assignment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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 curative intent.
- 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.
- 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 radiopharmaceutical.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177Lu]Lu-RTX-2358Also: PD-1 inhibitor[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 | Drug | [177Lu]Lu-RTX-2358 plus Immune Checkpoint Inhibitor |
Primary outcome
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first administration of [177Lu]Lu-RTX-2358 until 30 days after the last administration of study treatment.
To evaluate the safety and tolerability of [177Lu]Lu-RTX-2358 in combination with a PD-1 inhibitor by assessing the incidence, severity, seriousness, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs), graded according to NCI CTCAE version 5.0.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: From baseline until disease progression, initiation of new anticancer therapy, death, or up to 12 months after the last study treatment, whichever occurs first.
Disease Control Rate (DCR)
Time frame: Up to 12 months after the last study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [177Lu]Lu-RTX-2358 in people with Metastatic Non-small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: From the first administration of [177Lu]Lu-RTX-2358 until 30 days after the last administration of study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.