Antihistamine plus immunotherapy: a new hope for lung cancer patients?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits; * Aged 18-75 years, regardless of gender; * ECOG performance status score of 0-1; * Expected survival time ≥ 3 months; * \- Pathologically/radiologically confirmed stage II-III NSCLC (AJCC 9th Edition). For adenocarcinoma/adenosquamous carcinoma, EGFR wild-type and ALK fusion-negative required before enrollment; * No prior systemic anti-tumor therapy; * At least one measurable lesion per RECIST 1.1. Previously irradiated lesions are measurable if progression is confirmed; * Adequate organ function, as evidenced by meeting the following laboratory parameters: 1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L without administration of granulocyte colony-stimulating factor within the past 14 days; 2. Platelet count ≥ 80 × 10⁹/L without blood transfusion within the past 14 days; 3. Hemoglobin \> 8 g/dL without blood transfusion or erythropoietin administration within the past 14 days; 4. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); 5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable); 6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min; 7. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN; 8. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \[FT3\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment; 9. Myocardial enzyme profile within the normal range; * Females of childbearing potential: negative pregnancy test (urine/serum) within 3 days pre-first dose (Cycle 1 Day 1); serum test required if urine test unconfirmed. Non-childbearing females: postmenopausal ≥ 1 year, surgically sterile or hysterectomized; * Subjects at risk of conception: use contraception with annual failure rate \< 1% during treatment and 120-180 days post-last dose; Exclusion Criteria: * Lung metastases from other primary malignancies; * Other systemic malignancies (excluding radically treated skin basal/squamous cell carcinoma or resected carcinoma in situ); * Current or prior myasthenia gravis; * Current or prior angle-closure glaucoma; * Current or prior benign prostatic hyperplasia; * Diphenhydramine allergy; * Pyloroduodenal obstruction, peptic ulcer-induced pyloric stenosis or bladder neck stenosis; * Prior radiation therapy meeting any: 1) ≥ 30% bone marrow irradiated within 14 days pre-treatment; 2) Lung lesion radiation \> 30 Gy within 6 weeks pre-treatment (must recover from radiation toxicity to Grade ≤ 1, no glucocorticoids, no radiation pneumonitis history); * Current participation in other interventional clinical studies, or received investigational agents/devices within 4 weeks pre-first dose; * Systemic anti-lung cancer Chinese patent medicines or immunomodulators (thymosin, interferon, interleukin; excluding local pleural effusion control) within 2 weeks pre-first dose; * Active autoimmune diseases requiring systemic therapy (disease-modifying drugs, glucocorticoids, immunosuppressants) within 2 years pre-first dose (replacement therapy not considered systemic); * Ongoing systemic glucocorticoids (excluding topical) or immunosuppressants within 7 days pre-first dose (physiological doses: prednisone ≤ 10 mg/day or equivalent permitted); * Uncontrolled pleural/peritoneal effusion (eligible if no drainage needed or effusion stable 3 days post-drainage cessation); * Prior allogeneic organ transplantation (except corneal) or hematopoietic stem cell transplantation; * Inadequate recovery from prior intervention toxicities/complications (not resolved to Grade ≤ 1 or baseline, excluding fatigue/alopecia); * Known HIV infection (HIV 1/2 antibody positive); * Other conditions deemed unsuitable by investigator;