An Exploratory Study of QL1706 Plus Chemotherapy in Perioperative NSCLC

Exclusion Criteria

• •Patients meeting any of the following criteria will be excluded from the study:
• •Prior exposure to any immunotherapy.
• •ECOG performance status \>1.
• •Evidence of distant metastasis or intrathoracic metastatic disease.
• •Presence of actionable driver gene alterations with available targeted therapies, including but not limited to EGFR mutations, ALK fusions, ROS1 fusions, RET, NTRK, BRAF V600E mutations, or MET exon 14 skipping mutations.
• •Pregnant women (positive pregnancy test prior to treatment) or breastfeeding women.
• •Known hypersensitivity or intolerance to recombinant humanized PD-1 monoclonal antibodies or any of their components (or excipients).
• •Major surgery (excluding biopsy) within 4 weeks prior to the first dose of study treatment, or incomplete wound healing from prior surgery.
• •Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:
• •Acute myocardial infarction within 6 months prior to enrollment
• •Severe or unstable angina
• •Cerebrovascular accident or transient ischemic attack
• •Congestive heart failure (New York Heart Association class ≥II)
• •Arrhythmias requiring antiarrhythmic treatment (except beta-blockers or digoxin)
• •QTc interval \>480 ms on repeated ECG measurements
• •Hepatic or renal insufficiency, including conditions such as jaundice, ascites, and/or:
• •Total bilirubin \>3 × ULN
• •Urinary protein \>3.5 g/24 hours or renal failure requiring hemodialysis or peritoneal dialysis
• •Urinalysis showing proteinuria ≥++ or confirmed 24-hour urinary protein \>1.0 g
• •Persistent active infection of grade \>2 according to CTCAE version 5.0.
• •Active autoimmune disease or history of autoimmune disease within the past 2 years, or known/suspected autoimmune disease that may affect vital organ function or require systemic immunosuppressive therapy, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• •Allowed conditions include type I diabetes mellitus, hypothyroidism requiring hormone replacement only, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), or conditions not expected to recur without external triggers.
• •Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic immunosuppressive treatment.
• •Prior or planned solid organ transplantation or allogeneic bone marrow transplantation.
• •Active tuberculosis (Mycobacterium tuberculosis) or other active infections.
• •Known history of human immunodeficiency virus (HIV) infection.
• •Severe non-healing wounds, ulcers, or fractures.
• •History of substance abuse, or any medical, psychological, or social condition that may interfere with study participation, compromise compliance, or pose a safety risk.
• •Unresolved toxicities \> grade 1 from any prior therapy or procedure (CTCAE version 5.0), except for alopecia, anemia, or hypothyroidism.
• •Objective evidence of severe pulmonary dysfunction, including history of severe pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, or drug-related pneumonitis.
• •Concomitant malignancies or history of other malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, treated superficial bladder cancer, or prostate adenocarcinoma treated surgically with prostate-specific antigen (PSA) within normal limits.
• •Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
• •Concurrent participation in another clinical study.