A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

Inclusion Criteria

• •1. Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
• •2. No EGFR mutation or ALK rearrangement.
• •3. ECOG PS score 0 or 1.
• •4. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
• •5. Body weight ≥ 60.0kg and ≤ 75.0kg.
• •6. Adequate organ function per protocol-defined criteria.