Extensive-stage small cell lung cancer
Conditions
Interventions
Experimental Group:Sacituzumab tirumotecan in combination with tagitanlimab
Sponsors
Shandong First Medical University Affiliated Cancer Hospital (Shandong Provincial Institute of Cancer Prevention and Treatment, Shandong Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 within 7 days before administration. 3. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC); 4. Disease progression after previous first-line platinum-based chemotherapy combined with anti-PD -(L)1 standard treatment; 5. Chemotherapy-free interval (CTFI) >=3 weeks. CTFI: It refers to the time from the administration of the last dose of first-line platinum-based chemotherapy to disease progression. 6. If radiotherapy has been received in the past, the interval from the last radiotherapy session to the first administration should be at least 2 weeks. 7. According to RECIST 1.1v1.1, there should be at least one measurable lesion. Lesions that have received radiotherapy before should not be selected as target lesions. Subjects with only skin lesions or bone lesions cannot be included. 8. Expected survival period >=12 weeks; 9. Possessing adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to administration), defined as follows: a) Blood routine: Neutrophil count (NEUT#) >= 1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; Hemoglobin >= 90 g/L; b) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30g/L; Total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5×ULN; 10. For female subjects with fertility and male subjects whose partners have reproductive potential, they must agree to take effective medical contraceptive measures from the date of signing the informed consent form until 6 months after the last administration. 11. The subjects voluntarily joined this study, signed the informed consent form, and were able to comply with the visits and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1.Non-small cell lung cancer (including mixed small cell/non-small cell carcinoma); 2.Prior treatment with a TROP2-directed antibody-drug conjugate (ADC), or an ADC containing topoisomerase I inhibitor; 3.History of hypersensitivity to any component of investigational drugs SKB264 or KL-A167; 4.Personal history of steroid-requiring non-infectious interstitial lung disease (ILD)/pneumonitis, current presence of active ILD/non-infectious pneumonia, or suspicious unexplained pulmonary opacities on screening imaging that cannot rule out ILD/non-infectious pneumonitis; 5.Severe infection occurring within 4 weeks before first dose (including hospitalized complications, sepsis, or severe pneumonia); Active systemic antimicrobial therapy required within 2 weeks prior to dosing; 6.Known meningeal metastases, brainstem metastases, spinal cord compression/metastases; Active or untreated CNS metastases. Previously irradiated brain metastases permitted if clinically stable for =4 weeks off corticosteroids/anticonvulsants and without requirement for these medications over =14 days pre-enrollment; 7.Severe documented dry eye syndrome, meibomian gland dysfunction (MGD), blepharitis, or history of corneal disorders impairing wound healing; 8.Use of potent CYP3A4 inhibitors/inducers within 2 weeks prior to dosing and throughout the study duration (referential list in Annex 5). All subjects must strictly avoid CYP3A4-inducing drugs/herbal supplements/foods; 9.Uncontrolled hypertension (systolic >140 mmHg OR diastolic >90 mmHg despite optimal antihypertensive therapy); 10.Severe cardiac disease or pulmonary impairment with NYHA Class III/IV dysfunction (including Class III); 11.Active substance abuse disorder refractory to abstinence, or uncontrolled psychiatric illness; 12.Participation in another anticancer trial within 4 weeks of screening; 13.Concurrent malignancy except curatively treated basal cell carcinoma of skin, cervical carcinoma in situ, or superficial bladder cancer; 14.Coexisting medical conditions posing significant safety risks or compromising protocol compliance; 15.Pregnancy/lactation status; Fertile patients refusing or failing contraception; 16.Any other condition deemed by investigator to interfere with efficacy assessment, subject safety, or data interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Safety;Progression-Free Survival;Disease Control Rate;Overall surival; | — |
Countries
China
Contacts
Public ContactZhu Hui
Shandong First Medical University Affiliated Cancer Hospital (Shandong Provincial Institute of Cancer Prevention and Treatment, Shandong Provincial Cancer Hospital
Outcome results
None listed