Non-small cell lung cancer
Conditions
Interventions
Trial group:Lukangsatuzumab vedotin monotherapy at 5 mg/kg every two weeks
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed locally advanced (Stage IIIB/IIIC and not suitable for radical treatment) or metastatic non-small cell lung cancer (NSCLC); 2. Aged 18 to 75 years, regardless of gender; 3. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), which has not been locally treated such as radiotherapy (lesions within a prior radiotherapy field are acceptable as target lesions if progression has been demonstrated and they meet RECIST 1.1 criteria); 4. EGFR 20insertion, EGFR G719X, EGFR L861Q, S768I, or other non-classical EGFR mutations confirmed by gene test; 5. Previous treatment limited to one line of targeted therapy, with no prior platinum-based chemotherapy; 6. Expected survival >= 12 weeks; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to administration; 8. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: (1) Hematologic: Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelets (PLT) >= 100×10^9/L; Hemoglobin >= 9 g/dL; (2) Hepatic: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) = 60 mL/min; 9. Voluntary participation in this study, with signed informed consent, good compliance, and willingness to cooperate with follow-up; 10. Radiographic disease progression during or after the most recent treatment for locally advanced or metastatic disease.
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically confirmed tumor with components of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma; 2. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active and untreated central nervous system (CNS) metastases. Subjects with previously treated brain metastases could be enrolled if they are clinically stable for at least 4 weeks and have not required corticosteroids or anticonvulsants for at least 14 days; 3. Prior treatment with TROP2-targeted therapy; prior treatment with any topoisomerase I inhibitor or chemotherapy; or any immunotherapy such as immune checkpoint inhibitors or immune checkpoint agonists; 4. Uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical treatment); 5. Ongoing or active infection; 6. Participation in other anti-tumor clinical trials within 4 weeks before screening; 7. Adverse events of CTCAE grade > 1 (except alopecia) present before the first dose; 8. Other uncured malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ); 9. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding; 10. Active hepatitis B or hepatitis C; 11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 12. Allergy to the investigational drug or any of its components; 13. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging; 14. Clinically significant pulmonary impairment due to concurrent lung diseases, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune connective tissue and inflammatory diseases that may affect the lungs (e.g., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc.), or prior pneumonectomy; 15. Poorly controlled diabetes mellitus (fasting blood glucose >= 10 mmol/L on two consecutive tests); 16. Clinically symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage (> 1 time/week); 17. Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or history of corneal disease that may delay corneal healing; 18. Any condition that, in the investigator’s judgment, may interfere with the evaluation of the efficacy and safety, or any other condition deemed by the investigator to make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Safety;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Yan
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed