drugset / Trial / NCT04124731

Combination Therapy of Sintilimab and Anlotinib as a First-line Treatment in Advanced NSCLC (SUNRISE)

NCT04124731 ↗

Phase 2 Unknown 98 enrolled Shanghai Chest Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2019-10
Primary completion
2021-04
Completion
2022-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown Intravenous
Subject Catequentinib Small molecule 12 mg Oral
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous