non small cell lung cancer
Conditions
Interventions
surgery:Radical surgical resection
radiotherapy:To undergo curative radiotherapy
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, regardless of gender. 2. Histologically or cytologically confirmed NSCLC. 3. No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic anti-tumor therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine therapy, or any other investigational drug therapy. 4. According to the AJCC 9th edition TNM staging for lung cancer, previously untreated oncologically unresectable stage IIIA/IIIB disease, including: single-station N2 with bulky mediastinal lymph nodes (short axis >= 2 cm or confluent nodal masses), infiltration (extracapsular extension of mediastinal lymph nodes into surrounding mediastinal structures), or multi-station (N2b) N2 disease. Bulky and infiltrative single-station N2 requires pathological confirmation via biopsy. For multi-station N2, PET results may be considered for assessment based on the feasibility of biopsy. 5. Assessment by MDT that radical surgical resection is not feasible. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Patients must tolerate conversion therapy and surgery, with pulmonary function test showing FEV1 >= 1.2L or predicted postoperative FEV1 >=800 mL. Radical surgical resection with systematic lymph node dissection is recommended, provided that surgical margins can be secured and the patient's general condition permits. 8. Adequate organ function (see Section 8 for detailed criteria). 9. For female patients of childbearing potential, a negative serum pregnancy test result within seven days prior to the first dose of study drug (Cycle 1, Day 1) is required. Female patients of childbearing potential and male patients whose partners are women of childbearing potential must agree to use a medically approved contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) or have undergone surgical sterilization during the study treatment period and for at least 90 days after the last dose of study drug. 10. Life expectancy > 6 months. 11. Provision of signed informed consent by the patient or their legal representative.
Exclusion criteria
Exclusion criteria: 1. T4 tumors invading the aorta, esophagus, heart, and/or other organs or tissues, or T4 tumors with intrapulmonary metastases in a different ipsilateral lobe that cannot undergo radical surgery; confluent or multi-station lymph nodes encasing or invading the aorta, pulmonary artery, trachea, esophagus, heart, etc., assessed by MDT as not amenable to radical resection. 2. Exclusion of patients with resectable stage III disease according to the 9th edition staging, specifically: (1) cT2N2a (stage IIIA) with non-bulky, non-infiltrative single-station N2. (2) cT3-4N0-1 (stage IIIA). (3) cT3-4N2 (stage IIIB) with non-bulky, non-infiltrative single-station N2. 3. Patients with mixed small cell lung cancer. 4. Prior treatment with PD-1/PD-L1 inhibitors or agents targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.). 5. History of severe allergic reactions to other monoclonal antibodies. 6. History of severe allergy to pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin, or their prophylactic medications. 7. Patients with other malignancies within the past 5 years, except for: malignancies that have received curative treatment with no known active disease >=2 years prior to the first dose of investigational product and have a low potential risk of recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease. 8. Any unstable systemic disease, including active infection, uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg despite optimal medical therapy), unstable angina, angina pectoris within the last 3 months, liver disease requiring medication, kidney disease, or metabolic disease. 9. Cardiac function and disease meeting any of the following criteria: (1) Clinically significant arrhythmias deemed inappropriate for enrollment by the investigator, including but not limited to complete left bundle branch block, second-degree atrioventricular block. (2) QTc interval measured by 12-lead ECG >=450 ms in males or >=470 ms in females. (3) New York Heart Association (NYHA) class >= 3 cardiac insufficiency or echocardiogram: Left Ventricular Ejection Fraction (LVEF) <50%. Myocardial infarction occurred within 1 year prior to screening. 10. History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to first dose, or current presence of interstitial lung disease. 11. Confirmed human immunodeficiency virus (HIV) infection. 12. Untreated active hepatitis B. Note: Hepatitis B subjects meeting the following criteria may also not be excluded: (1) HBV viral load must be < 500 IU/mL or <1000 copies/mL prior to the first dose. The investigator may decide whether to administer anti-HBV therapy during the study based on the subject's condition. (2) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic anti-HBV treatment but require close monitoring for viral reactivation. 13. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection). 14. Known drug allergies (allergies to corresponding drugs confirmed according to the respective substudy). 15. Patients who have undergone major surgery or experienced severe trauma within 2 months prior to the first dose. 16. Clinically significant bleeding symptoms or a clear bleeding tendency within 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 years event free survival;5 years event free survival;2 years overall survival;3 years overall survival;5 years overall survival;overall response rate;surgery rate;R0 rate;Lymph node downstaging rate;Perioperative complication rate and severity;Major Pathologic Response;Pathologic Complete Response;Averse Events; | — |
Countries
China
Contacts
Public ContactWentao Fang
Shanghai East Hospital
Outcome results
None listed