Lung Cancer Clinical Trials

• Sign a written informed consent before implementing any trial-related procedures;

• Age ≥18 years and ≤75 years;

• Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgery and radical concurrent chemoradiotherapy, and subjects who have not previously received systemic treatment;

• Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;

• According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion on imaging. Lesions in previously irradiated fields can be considered measurable if confirmed to have progressed;

• No prior systemic anti-tumor treatment for advanced/metastatic disease. Subjects who previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be included if disease progression or recurrence occurs at least 6 months after the last chemotherapy drug treatment;

• Subjects with asymptomatic or symptomatically stable brain metastases after local therapy are allowed to enroll if they meet the following conditions: measurable lesions outside the central nervous system; no central nervous system symptoms or no worsening symptoms within at least 2 weeks; no need for corticosteroid therapy, or corticosteroids discontinued within 7 days prior to first dose, or corticosteroid dose stable and reduced to ≤10 mg/day prednisone (or equivalent) within 7 days prior to first dose;

• Patients may receive palliative radiotherapy, but completion must be at least 7 days before the first dose of the study drug, and radiotherapy-related toxicities must recover to ≤ grade 1 (CTCAE 5.0);

• ECOG performance status 0-1;

• Expected survival \>3 months;

• Sufficient organ function: subjects must meet the following laboratory criteria: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L without using granulocyte colony-stimulating factor in the past 14 days; platelet count ≥100 × 10⁹/L without transfusion in the past 14 days; hemoglobin \>9 g/dL without transfusion or erythropoietin use in the past 14 days; total bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (for subjects with liver metastases, ALT or AST ≤5 × ULN is allowed); serum creatinine ≤1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN; normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can still be included if total T3 (or FT3) and FT4 are within the normal range; myocardial enzyme spectrum within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed to enroll).

• For female subjects of childbearing potential, a urine or serum pregnancy test must be conducted within 3 days before the first study drug administration (Cycle 1, Day 1) and the result must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing female subjects are defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.

• If there is a risk of pregnancy, all subjects (male or female) must use contraception methods with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last study drug administration.