Advanced non-small cell lung cancer
Conditions
Interventions
Sacituzumab Tirumotecan for Injection
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at the time of signing the informed consent form, regardless of gender; 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) and not amenable to curative surgery and/or curative radiotherapy (with or without concurrent chemotherapy) [according to the 8th edition of the AJCC/UICC lung cancer TNM staging system]; 3. EGFR-sensitive mutations have been confirmed by tumor histology, cytology or hematology, including exon 19 deletion mutations or exon 21 point mutations (L858R), and PD-L1 TPS >= 50%; 4. No prior systemic therapy for locally advanced or metastatic NSCLC. Subjects who have previously received adjuvant/neoadjuvant chemotherapy or radical concurrent or sequential chemoradiotherapy for the purpose of cure for non-metastatic diseases are eligible to participate in this study if disease progression occurred >=12 months after the end of the last treatment; 5. At least one measurable lesion according to RECIST v1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days before administration; 7. Life expectancy >= 12 weeks; 8. Adequate organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose); 9. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraception from the signing of the informed consent form until 6 months after the last dose; 10. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the protocol-specified visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components in the tumor. 2. Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors. 3. Known presence of leptomeningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases. For subjects with brain metastases who have received prior local treatment, participation is permitted if they are clinically stable for at least 4 weeks before study drug administration and have not required glucocorticoids or anticonvulsants for at least 14 days; subjects with untreated asymptomatic brain metastases may be enrolled at the investigator's discretion. 4. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma or cutaneous squamous cell carcinoma. 5. Known history of allergic reactions to the study drugs or their components. 6. Positive HIV test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. The live vaccine was administered within 30 days prior to the first dose of study drug. 9. History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; clinically significant pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary disease or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs, or prior pneumonectomy. 10. Subjects requiring strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose and during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or consumption of foods known to induce CYP3A4. 11. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type 1 diabetes, hypothyroidism requiring only thyroxine replacement therapy, or adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy). 12. Active infection requiring systemic treatment within 2 weeks before the first dose. 13. With concomitant diseases that, in the investigator's judgment, pose a serious risk to the subject's safety or impair the subject's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc. 14. Presence of factors affecting oral drug administration (e.g., inability to swallow, gastrointestinal resection, chronic diarrhea, or intestinal obstruction). 15. Documented history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease that prevents delayed corneal healing. 16. Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive pregnancy test at baseline, or female patients of childbearing potential who are unwilling to use effective contraceptive measures during the study treatment period and for 6 months after the la
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission, DOR;Overall survival, OS ;Disease control rate, DCR;Safety;Progression Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactYanhong Shang
Affiliated Hospital of Hebei University
Outcome results
None listed