non-small cell lung cancer
Conditions
Interventions
Test group:Three Cycles of Neoadjuvant Immunotherapy Combined with Chemotherapy Followed by Two Cycles of Extended Toripalimab.
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, male or female. 2. ECOG performance status score of 0-1. 3. Pathologically confirmed, previously untreated non-small cell lung cancer (NSCLC). 4. Sufficient tumor tissue available for biomarker analysis. 5. Clinically staged as resectable stage II-IIIB NSCLC. Definition of resectability: According to the *Multidisciplinary Consensus Statement on the Clinical Management of Stage III Non-Small Cell Lung Cancer (2019)*, resectability is defined as resectable or potentially resectable. Resectable NSCLC includes stage IIIA (N0-1), selected N2 disease with single-station mediastinal lymph node (short-axis diameter =1.5×10?/L, platelet count >=100×10?/L, hemoglobin >=9 g/dL. Liver function: Serum total bilirubin =60 mL/min; Blood urea nitrogen (BUN) =2 L; if baseline FEV1 800 mL must be confirmed by a surgical specialist. Cardiac function: No myocardial infarction within the past year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency. 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 months, confirmed again within a few days prior to the first dose. Both female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use highly effective contraception during the study period and for at least 180 days after the last dose. 10. Willing and able to understand and voluntarily provide written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. Presence of locally advanced, unresectable, or metastatic disease. Unresectable disease is defined according to the following criteria from the multidisciplinary consensus statement on the clinical management of Stage III non-small cell lung cancer: Stage IIIC disease; Stage IIIB with N3 lymph node metastasis; Stage IIIA or Stage IIIB with single-station mediastinal N2 lymph node metastasis (short-axis diameter >= 3 cm); N2 metastasis characterized by multi-station confluent lymph nodes on CT (short-axis diameter = 2 cm); T4 disease with invasion of the esophagus, heart, aorta, or other adjacent structures; or the subject is deemed unresectable by the investigator. 2. Pathological diagnosis of combined small cell lung carcinoma, etc. 3. Prior lobectomy surgery or history of prior radiotherapy or chemotherapy. 4. Presence of a concurrent second primary cancer or history of a malignant tumor within the past 5 years (except for completely cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer). 5. Any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.). 6. Active infection requiring systemic therapy or a history of active tuberculosis. 7. Co-existing active infectious diseases, including Hepatitis B with "" status (HBsAg-positive, HBeAg-positive, and anti-HBc-positive), known human immunodeficiency virus (HIV) infection, active syphilis, or other sexually transmitted diseases. 8. Known or concurrent presence of other uncontrolled diseases that preclude the patient from undergoing surgical treatment. 9. Any physical examination finding or clinical trial finding that, in the investigator's opinion, may interfere with the results or increase the patient's risk of treatment complications. 10. History of interstitial lung disease (ILD), drug-induced ILD, or any clinically active ILD; evidence of idiopathic pulmonary fibrosis on baseline CT scan; uncontrolled large pleural effusion or pericardial effusion. 11. Unstable concomitant systemic diseases (active infection, moderate-to-severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, hepatic, renal, or other metabolic diseases, neuropsychiatric disorders such as Alzheimer's disease). 12. Congenital or acquired immunodeficiency diseases or history of organ transplantation. 13. Prior treatment with any of the following: Prior radiotherapy or chemotherapy; prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or other drugs acting on co-inhibitory T-cell receptors such as CTLA-4, OX-40, CD137. Received any investigational drug within 4 weeks prior to the first dose of the study drug. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study. Received a live vaccine within 30 days prior to the first treatment, including but not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines (inactivated virus vaccines are allowed). 14.History of severe hypersensitivity to monoclonal antibodies or chemotherapy drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Perioperative complications;R0 excision rate; Treatment Emergent Adverse Events ;Event-free survival time (EFS);Overall survival time (OS);Complete Pathological Response Rate (pCR Rate); | — |
Countries
China
Contacts
Public ContactHao Zhang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed