Lung cancer
Conditions
Interventions
Trial group:1. Lukangshatuzumab adizutecan will be administered at 4 mg/kg as an intravenous infusion every 2 weeks, with dosing on Day 1 of each cycle.
2. Tagolitinib will be administered at 900 mg
Sponsors
The Second Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years at the time of informed consent signing, regardless of gender; 2. ECOG performance status of 0–1 within 7 days prior to drug administration; 3. Confirmed diagnosis of NSCLC by histology or cytology; 4. No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic anti-tumor therapy, including cytotoxic chemotherapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine, or any other investigational drugs; 5. Eligible as a surgically resectable cIIA–IIIB NSCLC patient based on MDT evaluation, according to the 8th edition of the UICC/AJCC TNM staging system; 6. Presence of at least one measurable lesion according to RECIST v1.1 criteria; 7. Willingness to undergo curative-intent surgical resection; 8. Surgical assessment confirms resectability with no contraindications to surgery; 9. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor administration within 2 weeks prior to first dose), defined as: (1) Hematologic parameters: Absolute neutrophil count (NEUT#) >= 1.5 × 10^?/L; platelet count (PLT) >= 100 × 10^?/L; hemoglobin >= 9 g/dL; (2) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 60 mL/min (Cockcroft-Gault formula; see Appendix); (4) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) = 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan; 10. For female participants of childbearing potential and male participants with partners of childbearing potential, effective medical contraception must be used from the time of informed consent signing until 6 months after the last dose; 11. Participants voluntarily enroll in the study, sign the informed consent form, and are able to comply with the scheduled visits and protocol-mandated procedures.
Exclusion criteria
Exclusion criteria: 1. Tumor histology or cytology showing combined small-cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components. 2. Prior therapy with anti–PD-1, anti–PD-L1, anti–PD-L2, anti–CTLA-4, or any other antibody/drug targeting T-cell co-stimulatory or checkpoint pathways. 3. Previous TROP2-directed therapy and/or topoisomerase I inhibitor treatment. 4. Other malignancies within 5 years, except adequately cured cervical carcinoma in situ, basal-cell carcinoma, or squamous-cell carcinoma of the skin. 5. Known hypersensitivity to study drugs or their excipients, history of immunodeficiency, or prior organ transplantation. 6. Interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, current ILD/pneumonitis, or imaging findings suspicious for ILD that cannot be ruled out; clinically significant pulmonary impairment due to concomitant lung disorders—including but not limited to pulmonary embolism within 3 months, severe asthma, severe COPD, restrictive lung disease, pleural effusion—or any autoimmune, connective-tissue, or inflammatory disease potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis); previous pneumonectomy. 7. Any concurrent condition judged by the investigator to jeopardize patient safety or study completion, including uncontrolled hypertension, severe diabetes mellitus, active infection, etc. 8. Active hepatitis B (HBsAg positive with HBV-DNA >= 500 IU/mL or above lower limit of detection [LLoD], whichever is higher); hepatitis C (anti-HCV positive and HCV-RNA > LLoD); positive HIV test or history of AIDS; active syphilis. Note: HBsAg-positive subjects must receive anti-HBV therapy during the study. 9. Documented severe dry-eye syndrome, severe meibomian gland disease/blepharitis, or corneal disorders that could impair/delay corneal healing. 10. Pregnant or lactating women. 11. Any condition that, in the investigator’s opinion, could interfere with the evaluation of study drug, patient safety, or interpretation of results, or any other reason considered unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response rate, MPR;Objective Response Rate, ORR;Event-Free Survival, EFS;Overall Survival , OS; | — |
Countries
China
Contacts
Public ContactFan Junqiang
The Second Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed