A Phase II Study of QL1706 and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Korábbi kezelés

• Recurrence within 6 months after completing prior adjuvant therapy (if applicable).
• Comorbidities requiring immunosuppressive medications, including systemic corticosteroids at immunosuppressive doses.
• Treatment with any investigational drug within 4 weeks prior to the first dose of study treatment.
• Use of Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study treatment initiation.
• Uncontrolled thrombotic events within 6 months prior to screening.
• Administration of a live vaccine within 28 days prior to the first study dose.
• Major surgery or significant trauma within 4 weeks prior to the first study dose.

Más betegség

• Active, known, or suspected autoimmune disease (with specific exceptions, e.g., vitiligo, type I diabetes, hypothyroidism managed with hormone replacement only).
• Active tuberculosis (TB) infection or history of active TB within the past year.
• Symptomatic interstitial lung disease that could interfere with the detection or management of suspected drug-related pulmonary toxicity.
• Known HIV infection, active Hepatitis B (HBsAg positive with HBV-DNA > 10\^3 copies/mL), or active Hepatitis C (HCV antibody positive with detectable HCV-RNA).
• Significant history of neurological or psychiatric disorders.
• History of another active malignancy within the past 2 years (with specific exceptions for certain early-stage cancers).
• Significant cardiovascular or cerebrovascular disease history.
• Conditions that may impair oral drug absorption.
• Uncontrolled active infection requiring systemic therapy.
• Known hypersensitivity to any of the study drug components.
• Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.

Egyéb

• Participants meeting any of the following criteria will be excluded from the study:
• Pathological diagnosis containing a small cell component.
• Symptomatic brain metastases.
• Leptomeningeal metastases.
• Pregnancy or lactation in female participants.

• Participants must meet all of the following criteria to be eligible for the study:
• Voluntary participation and provision of signed written informed consent.
• Age ≥ 18 years.
• Life expectancy ≥ 3 months.
• Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy.
• Tumor demonstrates loss of BRG1 protein (encoded by the SMARCA4 gene) as confirmed by immunohistochemistry (IHC).
• No prior systemic anti-cancer therapy for advanced disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Willingness to provide archived or fresh tumor tissue samples from primary or metastatic lesions. If unavailable, enrollment may be permitted following investigator assessment.
• At least one measurable lesion as defined by RECIST v1.1.
• Adequate organ function within the screening period, as evidenced by:
  • 10.1 Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L 10.2 Platelet count ≥ 100 × 10\^9/L 10.3 Hemoglobin ≥ 90 g/L (without transfusion within 14 days) 10.4 Serum creatinine ≤ 1 × ULN OR Creatinine clearance > 50 mL/min (calculated by Cockcroft-Gault formula) 10.5 AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) 10.6 Total bilirubin ≤ 1.5 × ULN (except for participants with Gilbert's syndrome) 10.7 TSH, FT3, and FT4 within normal limits (±10%)