Metastatic Lung Cancer
Conditions
Interventions
Intervention group:177Lu-CD147
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 years (inclusive), regardless of gender. 2. Patients with lung cancer confirmed by pathological biopsy. 3. Patients with distant metastasis (M1) confirmed clinically or by imaging. 4. Patients with recurrence or metastasis after receiving second-line or subsequent therapy, for whom no standard treatment is recommended per NCCN guidelines. 5. Moderate or high expression of CD147 on immunohistochemistry (weak to moderate intensity, complete, and uniform cell membrane staining in more than 10% of infiltrating tumor cells; tissue sampling must have been performed within 1 year prior to enrollment). 6. ECOG performance status score of 0–1. 7. Expected survival of at least 12 weeks. 8. Laboratory test results meeting the following criteria: a. Complete blood count: WBC = 4.0 × 10?/L or neutrophils >= 1.5 × 10?/L, PLT >= 100 × 10?/L, Hb >= 90 g/L. b. Coagulation: PT or APTT <= 1.5 × ULN (upper limit of normal). c. Liver and kidney function: T-Bil <= 1.5 × ULN, ALT/AST <= 2.5 × ULN (or <= 5 × ULN in subjects with liver metastasis), ALP <= 2.5 × ULN (or <= 4.5 × ULN in subjects with bone or liver metastasis); BUN <= 1.5 × ULN, SCr <= 1.5 × ULN. 9. At least one measurable target lesion according to RECIST 1.1 criteria. 10. Female subjects must use effective contraception during the study and for 6 months after the study ends (effective contraception includes sterilization, intrauterine hormone devices, condoms, contraceptive pills/agents, abstinence, or partner’s vasectomy). Male subjects must agree to use contraception during the study and for 6 months after the study ends. 11. Patients capable of understanding and voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of any of the following conditions: carcinomatous meningitis, myocardial infarction (within 6 months prior to enrollment), unstable angina, high risk of uncontrolled arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months prior to enrollment), congestive heart failure (NYHA class III–IV), pulmonary embolism, deep vein thrombosis, infection requiring intravenous antibiotic treatment within 2 weeks (patients with infection symptoms should be evaluated by a respiratory specialist for indications of intravenous antibiotic use), or treatment with immunosuppressants after organ transplantation; 2. Patients with intracranial metastases (except for asymptomatic brain metastases not requiring treatment); 3. HBV DNA >= 104 copies/mL or >= 2000 IU/mL; 4. HCV-RNA >= 1000 copies/mL; 5. Positive for HIV antibody or syphilis antibody; 6. History of acute or subacute intestinal obstruction, or inflammatory bowel disease; 7. Women who are pregnant, breastfeeding, or planning to become pregnant; 8. Known allergy to the investigational agent or its excipients; 9. History of psychoactive drug abuse that cannot be discontinued, or presence of psychiatric disorders; 10. Patients unable to lie flat for at least 30 minutes; 11. Allergy to any component of the imaging agent or antibody; 12. Patients unable to undergo PET/CT or SPECT/CT imaging; 13. Any other condition considered by the investigator as unsuitable for participation in the trial; 14. Contraindications to enhanced MRI or enhanced CT examinations; 15. Any other condition deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodistribution in humans and internal radiation dose of 177Lu-CD147.; | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity; AI pharmacokinetics;anti-tumor effect; | — |
Countries
China
Contacts
Public ContactXiaobo Du
Mianyang Central Hospital
Outcome results
None listed