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SUNRISE: A Phase II Randomized Control Study of Sintilimab Combined With Anlotinib Versus Standard Platinum-based Chemotherapy as a First-line Treatment in Patients With Advanced NSCLC
This is an open label, multi-center, randomized control phase II trial, to compare the efficacy and safety of sintilimab combined with anlotinib versus standard platinum-based chemotherapy as a first-line treatment in advanced NSCLC patients without driven-gene mutations.
Details
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 98 |
| Start date | 2019-10 |
| Completion | 2022-04 |
Conditions
- Carcinoma
- Non-small Cell Lung Cancer
Interventions
- sintilimab plus anlotinib
- Chemotherapy
Primary outcomes
- Objective Respond Rate (ORR) — up to 24 months after enrollment or study close
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).