NCT04976647

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

A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX10+chemo	HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
DRUG	HLX10+HLX07+chemo	HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
DRUG	HLX10+HLX07	HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;

Timeline

• Start date: 2022-01-18
• Primary completion: 2023-01-30
• Completion: 2024-10-30
• First posted: 2021-07-26
• Last updated: 2022-05-06

Locations

1 site across 1 country: China