A Phase 2 Randomized, Controlled Trial of QL1706 Plus Chemotherapy and Quad Shot for Driver Gene-negative Advanced Non-small Cell Lung Cancer.

Inclusion Criteria:

1. Confirmed age: 18-75 years;

2. Histologically or cytologically diagnosed as lung squamous cell carcinoma or lungadenocarcinoma;

3. Staged as stage IV (T1-4NxM1) according to the Union for International CancerControl/American Joint Committee on Cancer (UICC/AJCC) Cancer Staging System (9thedition), with at least 2 evaluable lesions, including one distant metastaticlesion;

4. Driver gene-negative;

5. ECOG performance status: 0-1;

6. Normal bone marrow function: white blood cell count > 4×10⁹/L, hemoglobinconcentration > 90 g/L, platelet count > 100×10⁹/L;

7. Normal liver and kidney function: total bilirubin ≤ 1.5×upper limit of normal (ULN);aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5×ULN; alkalinephosphatase (ALP) ≤ 2.5×ULN; creatinine clearance ≥ 60 mL/min;

8. Normal results of thyroid function, amylase, lipase, pituitary function,inflammatory/infectious markers, myocardial enzymes, and electrocardiogram (ECG).For patients aged > 50 years with a smoking history, normal pulmonary function testresults are required. For patients with abnormal ECG or a history of cardiovasculardisease (that does not meet the exclusion criteria listed in item 7), additionalmyocardial function tests and echocardiography are required, with normal results;

9. Patients have signed the informed consent form and are willing and able to complywith follow-up, treatment, laboratory tests, and other study requirements asspecified in the study schedule;

10. Female subjects of childbearing potential must agree to use reliable contraceptivemethods (e.g., condoms, regularly used contraceptives as prescribed by a physician)from screening until 1 year after treatment.

Exclusion Criteria:

1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNAquantitation > 1×10³ copies/mL, or positive for anti-hepatitis C virus (HCV)antibody;

2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS);

3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis withinthe past year, regardless of treatment status, should be excluded. Patients with ahistory of active tuberculosis more than 1 year ago should be excluded, except thosewith confirmed regular anti-tuberculosis treatment in the past;

4. Active, known, or suspected autoimmune diseases (including but not limited touveitis, enteritis, hepatitis, pituitary disorders, nephritis, vasculitis,hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators). Exceptionsinclude type 1 diabetes mellitus, hypothyroidism requiring hormone replacementtherapy, and skin diseases not requiring systemic treatment (e.g., vitiligo,psoriasis, or alopecia);

5. A history of interstitial lung disease or pneumonia within the past year requiringoral or intravenous steroid treatment;

6. Chronic systemic glucocorticoid therapy (dose equivalent to or exceeding 10 mgprednisone per day) or any other form of immunosuppressive therapy. Subjectsreceiving inhaled or topical corticosteroids are eligible;

7. Uncontrolled heart disease, such as: 1) Heart failure with NYHA class ≥ 2; 2)Unstable angina pectoris; 3) History of myocardial infarction within the past year;

4. Supraventricular or ventricular arrhythmias requiring treatment or intervention;

8. Pregnant or lactating women (pregnancy testing should be considered for sexuallyactive women of childbearing age);

9. Previous or current malignant tumors other than adequately treated non-melanoma skincancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;

10. Hypersensitivity to macromolecular protein preparations or any component of QL1706;

11. Active infection within 1 week requiring systemic treatment;

12. Receipt of live vaccines within 30 days prior to the first course of immunotherapy;

13. History of organ transplantation;

14. Other conditions assessed by investigators that may endanger patient safety orcompliance, such as severe diseases requiring prompt treatment (including mentalillnesses), significantly abnormal test results, or other psychological, family, orsocial high-risk factors.