drugset / Trial / NCT04976647

A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

NCT04976647

Phase 2 Unknown 156 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

Timeline

Start
2022-01-18
Primary completion
2023-01-30
Completion
2024-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PIMURUTAMAB Monoclonal antibody 1500 mg Intravenous
Comparator Paclitaxel Small molecule 260 mg/m2 Intravenous
Comparator carboplaitin Unknown Intravenous
Comparator Serplulimab Monoclonal antibody 300 mg Intravenous