Clinical trial · Interventional
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
NCT04177290CI-TRIAL-00064283completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab (approved) | Drug | Sintilimab | ALIAS |
| Sintilimab (M1b) | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- sintilimab (M1b) 200mg
- interventionNames
- Drug: Sintilimab (M1b)
- type
- ACTIVE_COMPARATOR
- label
- sintilimab (approved) 200mg
- interventionNames
- Drug: Sintilimab (approved)
Primary outcomes (1)
- measure
- PK is defined as AUC0-∞.
- timeFrame
- 28 days
Secondary outcomes (2)
- measure
- PK is defined as Cmax.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.