A Phase I Study of HS-20093 Injection in Combination Therapy in Non-Small Cell Lung Cancer

Korábbi kezelés

• Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.

Laborértékek

• Presence of any of the following abnormal cardiac findings:
  • 1\) Evidence of currently clinically significant important arrhythmia or ECG abnormality; 2) Presence of risk factors causing QT interval prolongation or arrhythmic events.
  • 3\. Untreated or uncontrolled brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
  • 4\. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 5. Severe or poorly controlled hypertension and/or diabetes mellitus. 6. Has experienced ≥ grade 2 bleeding events 7. Persistent adverse reactions caused by prior treatment. 8. History of other primary malignancies. 9. Severe infection. 10. History of severe arterial or venous thromboembolic events. 11. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
  • 12\. Participants with active or history of autoimmune disease with potential for recurrence.
  • 13\. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • 14\. Pregnant or breastfeeding, or planning to breastfeed during the study.

• Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
• Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
• Previously untreated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations
• Presence of at least one measurable target lesion.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
• Minimum life expectancy \>12 weeks.
• Adequate organ function.
• Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
• Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.