Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)

Prior treatment

• Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
• Other serious or uncontrolled systemic diseases assessed by the investigator.
  • Part A Dose escalation:
  • 1\. Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks
  • Part B Dose Expansion:
• Any prior systemic anti-tumor therapy
• Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)

Other illness

• Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
• Prior malignancy within 5 years
• History of organ transplantation or hematopoietic stem cell transplantation
• Sever lung function decline or interstitial lung disease that has required oral or IV steroids
• Active autoimmune disease requiring systemic therapy within 2 years
• Active infections
• Significant cardiac disorder

Other

• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Be able to provide a signed and dated, written informed consent.
• Adults aged ≥18 to 75 years.
• ECOG performance status 0-1.
• Predicted life expectancy ≥ 12 weeks
• Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
• Without EGFR or ALK mutations.
• Adequate bone marrow reserve and organ system functions.
• Patients with stable and symptomatic brain metastasis (BM) can be enrolled.
  • Part A Dose escalation:
  • Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC
  • Part B dose expansion:
• At least one measurable lesion according to RECIST 1.1.
• Previously systemic untreated for advanced disease.
• PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)