Radar de Estudos Clínicos

• Histopathological evidence of any small cell carcinoma component, or diagnosis of large cell neuroendocrine carcinoma or sarcomatoid carcinoma.

• Presence of another malignancy within 3 years prior to the first dose, except for tumors that have been clinically cured by local treatment and have an extremely low risk of recurrence (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma of the skin, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix, localized prostate cancer, etc.), or tumors with disease-free survival ≥ 3 years after curative treatment and an extremely low risk of recurrence or metastasis (e.g., ductal carcinoma in situ after radical surgery, papillary thyroid carcinoma after radical surgery, etc.).

• Insufficient washout from prior treatments before the first dose, including:

  1. Use of any investigational drug within 28 days prior to the first dose;

  2. Use of traditional Chinese herbal medicine or proprietary Chinese medicine with clear anti-tumor indications within 14 days prior to the first dose;

  3. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days prior to the first dose;

  4. Requirement for systemic glucocorticoids (>10 mg/day prednisone or equivalent doses of other glucocorticoids) for more than 7 consecutive days, or immunosuppressive therapy, within 14 days prior to the first dose.

     Exceptions include inhaled or topical corticosteroids, or physiologic replacement doses for adrenal insufficiency. Short-term (≤7 days) corticosteroid use is permitted for prophylaxis (e.g., prevention of contrast-agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure);

  5. Major surgery (e.g., abdominal or thoracic surgery) within 28 days prior to the first dose, excluding minor procedures such as diagnostic puncture, implantation of infusion devices, or biliary stent placement, or anticipated need for major surgery during the study period;

  6. Receipt of live vaccines within 28 days prior to the first dose, or planned administration of live vaccines during the study period.

• Presence of interstitial lung disease (ILD) or risk factors related to non-infectious pneumonitis, including:

  1. History or current presence of ILD or non-infectious pneumonitis requiring systemic glucocorticoids or other immunosuppressive therapy;
  2. Suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging during the screening period.

• Presence of active autoimmune disease requiring systemic treatment within the past 2 years (e.g., treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs).

Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment.

• Uncontrolled infections, including but not limited to:

  1. Active HBV or HCV infection. Patients positive for HBsAg must undergo HBV-DNA testing; if HBV-DNA exceeds the lower limit of detection of the local laboratory, enrollment is permitted provided antiviral therapy is administered.

     Patients positive for HCV-Ab may be enrolled if HCV-RNA is negative;

  2. Severe infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose;

  3. History of immunodeficiency, positive HIV test, or history of acquired immunodeficiency syndrome (AIDS);

  4. Known active tuberculosis;

  5. Active syphilis.

• History of allogeneic bone marrow transplantation or organ transplantation.

• Known hypersensitivity to any component of the investigational drug, or a history of severe allergic reactions to other antibody-based therapies.

• Pregnant or breastfeeding women, or women planning to become pregnant during the study period.

• Known psychiatric disorders, substance abuse, alcohol abuse, or any other condition that, in the investigator's judgment, may affect the safety of study treatment or subject compliance.

• Any other disease, treatment, or laboratory abnormality, either past or present, that in the investigator's judgment may interfere with the evaluation of safety or efficacy, prevent full participation in the study, or make participation not in the subject's best interest.