Lung Cancer
Conditions
Interventions
SKB264 (4 mg/kg, Day 1, Q2W) + Anlotinib (8 mg, Days 1-14, Q3W) :SKB264 (4 mg/kg, Day 1, Q2W) + Anlotinib (8 mg, Days 1-14, Q3W) will be administered until disease progression, death, unacceptable tox
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years old, open to both men and women; 2. Locally advanced (stage IIIB/IIIC), metastatic (stage IV) NSCLC driver genes (no EGFR, ALK, ROS1, etc.) confirmed histologically or cytologically confirmed incurable surgical resection and unresponsive to radical simultaneous/sequential chemoradiotherapy; 3. Disease progression after at least one line of platinum-based chemotherapy combined with anti-PD-(L)1 therapy; and at least 4 weeks after the most recent radiotherapy; 4. ECOG physical condition score 0-1; 5. At least one measurable lesion (RECIST 1.1 criteria); 6. Expected survival > = 12 weeks; 7. Possesses adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: (1) Blood count: Neutrophil count (NEUT#) > = 1.5 x 10^9/L; Platelet (PLT) > = 100 x 10^9/L; Hemoglobin > = 9 g/dL; (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 g/L; Total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) =50%; 8. For female subjects of reproductive potential and male subjects whose partners have fertility, consent to effective medical contraception must be given within 6 months from the signing of the informed consent form until the last dose; 9. Subjects voluntarily join this study, sign informed consent forms, and are able to comply with the visit and related procedures specified in the program.
Exclusion criteria
Exclusion criteria: 1. Histology: Histologically or cytologically confirmed NSCLC with mixed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid components. 2. Other Malignancies: History of other malignant tumors within the past 5 years, with the exception of cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or cutaneous squamous cell carcinoma. 3. Hemoptysis Risk: Central squamous cell carcinoma with a risk of massive hemoptysis. 4. Prior Targeted Therapy: Previous treatment with TROP2-targeted therapies or therapies targeting Topoisomerase I (including ADC drugs). 5. Anti-angiogenic Therapy: Prior use of Anlotinib Hydrochloride capsules or other anti-angiogenic drugs. 6. Drug Interactions: Requirement for strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study. The use of strong CYP3A4 inhibitors or inducers is prohibited in this study. All subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4. 7. Prior Clinical Trials: Participation in other clinical drug trials within 4 weeks prior to enrollment. 8. Allergy: Known history of allergy to the study drugs or their components. 9. Infectious Diseases: Positive for Human Immunodeficiency Virus (HIV) or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection. 10. Transplant History: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 11. Vaccination: Receipt of live vaccines within 30 days prior to the first study dose. 12. CNS Metastases: Known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases. Subjects with brain metastases previously treated with local therapy may participate if they are clinically stable for at least 4 weeks prior to dosing and have not required corticosteroids or anticonvulsants for at least 14 days. Subjects with untreated, asymptomatic brain metastases may be enrolled at the investigator's discretion. 13. Uncontrolled Systemic Disease: Uncontrolled systemic diseases as judged by the investigator, including: (1) Poorly controlled diabetes (fasting blood glucose >= 10 mmol/L on two consecutive occasions); (2) Poorly controlled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg); (3) Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (> 1 time/week). 14. Infection: Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose. 15. Lung Disease: History of non-infectious interstitial lung disease (ILD) or pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. Severe pulmonary impairment due to concurrent lung diseases, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to dosing, severe asthma, severe COPD, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. 16. Autoimmune Disease: Active autoi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Time to Response;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactLing Xu
Anhui Chest Hospital
Outcome results
None listed