Advanced or Metastatic NSCLC
Conditions
Brief summary
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment
Interventions
DRUGSintilimab (M1b)
Intravenous infusion
Intravenous infusion
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Exclusion criteria
1. Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies. 2. Allergic to any component of sintilimab. 3. Active autoimmune diseases. 4. Clinically unstable central nervous system metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK is defined as AUC0-∞. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| PK is defined as Cmax. | 28 days |
| Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0. | from randomization through 90 days after last dosing |
Countries
China
Outcome results
None listed