Lung Cancer
Conditions
Interventions
Experimental Group :1. Immunotherapy: Sintilimab: 200 mg, intravenous infusion, day 1
every 21 days is one cycle, total of 3 cycles.
2. Chemotherapy:
(1) For adenocarcinoma patients: Carboplatin: AUC = 5, IV, day 1
Pemetrexed: 500 mg/m^2, IV, day 1
every 21 days is one cycle, total of 3 cycles.
(2) For non-adenocarcinoma patients: Carboplatin: AUC = 5, IV, day 1
Albumin-bound paclitaxel 100 mg/m^2, IV, on days 1, 8, 15
every 21 days is one cycle, total of 3 cycles.
3. Vitamin K2: During neoadjuvant immunochemotherapy, Vitamin K2 is given at the same time. It is taken orally at a dose of 45 mg/day (MK-4), starting f
every 21 days is one cycle, total of 3 cycles.
(2) For squamous cell carcinoma patients: Carboplatin: AUC = 5, IV, day 1
Gemcitabine: 1000 mg/m^2, IV, on days 1, 8, 15
every 21 days is one cycle, total of 3 cycles.
6. Vitamin K2 (postoperative): During neoadjuvant immunochemotherapy, Vitamin K2 is given at the same time. It is taken orally at a dose of 45 mg/day (M
Sponsors
The Second Affiliated Hospital, Zhejiang University College of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), with clinical stage II or IIIA, or selective stage IIIB patients (N2 only, excluding N3 disease) assessed by the multidisciplinary team (MDT) as potentially amenable to radical resection, staged according to the 8th edition of the AJCC TNM staging system. 2. At least one measurable lesion according to RECIST version 1.1. 3. Age >= 18 years, either sex. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 5. No prior systemic antineoplastic therapy for NSCLC. 6. Adequate organ function, defined as follows: (1) Hepatic function: serum total bilirubin (TBIL) = 60 mL/min, calculated using the Cockcroft-Gault formula: Female: Ccr = (140 - age) x weight (kg) x 0.85 / [72 x serum creatinine (mg/dL)]; Male: Ccr = (140 - age) x weight (kg) x 1.00 / [72 x serum creatinine (mg/dL)]; Note: For patients aged >= 65 years or those with normal serum creatinine but Ccr = 12 weeks. Women of childbearing potential, and male patients whose partners are women of childbearing potential, must use effective contraception throughout the treatment period and for 180 days after the last dose of investigational product. 8. Signed written informed consent, with ability to comply with the visit schedule and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical study involving investigational drugs within 3 weeks prior to study enrollment. 2. History of allogeneic organ transplantation. 3. History of interstitial lung disease, idiopathic pulmonary fibrosis, or pneumonitis (including drug-related pneumonitis), or evidence of active pneumonitis on chest CT during screening. 4. Presence of active or previously diagnosed autoimmune or inflammatory diseases, including but not limited to: inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease), systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc. Patients with active diverticulitis within 3 months prior to enrollment are also excluded. The following exceptions apply: (1) Patients with vitiligo or alopecia only; (2) Hypothyroidism (e.g., Hashimoto's thyroiditis) controlled with stable hormone replacement therapy; (3) Chronic skin diseases not requiring systemic treatment; patients with no active disease manifestations within the past 5 years and deemed eligible for enrollment by the investigator after assessment; (4) Patients with celiac disease stable on diet control only. 5. History of active primary immunodeficiency. 6. History of active or previously diagnosed central nervous system metastases (including carcinomatous meningitis). 7. Uncontrolled seizure disorder. 8. Presence of uncontrolled severe comorbidities, including but not limited to: symptomatic congestive heart failure, uncontrolled diabetes or hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease; or presence of psychiatric disorders or social factors that may affect study compliance or capacity to provide informed consent. 9. Presence of active infection, including but not limited to: tuberculosis (based on clinical evaluation, including medical history, physical examination, imaging, and combined with locally routine tuberculosis-related testing), hepatitis B (known positive hepatitis B surface antigen [HBsAg]), hepatitis C, or human immunodeficiency virus infection (HIV-1/2 antibody positive). The following conditions are eligible for enrollment: (1) Patients with prior or resolved hepatitis B infection, i.e., positive hepatitis B core antibody (anti-HBc) and negative HBsAg; (2) Patients with positive hepatitis C antibody may be enrolled only if HCV RNA polymerase chain reaction (PCR) testing is negative. 10. Patients with unresolved adverse reactions from prior treatment for other malignancies (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] >= Grade 2), except for alopecia, vitiligo, and laboratory abnormalities explicitly permitted in the inclusion criteria. Patients with >= Grade 2 peripheral neuropathy must be assessed by the investigator, and case-by-case decisions on enrollment may be made after discussion. Patients with irreversible adverse reactions not expected to worsen further with investigational treatment (e.g., hearing loss, peripheral neuropathy, etc.) may also be considered for enrollment after investigator assessment. 11. Patients who experienced >= Grade 3 immune-related adverse events (irAEs) during prior treatment with any immunotherapy drug, or those with current immune-related adverse events that have not recovered to <= Grade 1. 12. Known history of allergic or hypersensitivity reactions to any
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response,MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response,pCR;objective response rate,ORR;event-free survival,EFS; | — |
Countries
china
Contacts
Public ContactJunqiang Fan
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed