NCT04750083

HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

A Phase II/III Study Comparing HX008 (a Humanized Monoclonal Antibody Against PD-1) Plus Chemotherapy With Pembrolizumab Plus Chemotherapy as the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Taizhou Hanzhong biomedical co. LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This a phase II-III study. In the single-armed phase II period, HX008, a monoclonal antibody targeting PD-1, will be combined with pemetrexed+platinum (Investigators choice of cisplatin or carboplatin) chemotherapy to treat participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. When the preliminary efficacy and safety data are acquired, a single-blinded phase III study will ensue, in which the efficacy and safety of HX008+pemetrexed+platinum VS pembrolizumab+pemetrexed+platinum in participants of the same population will be compared head-to-head with 1:1 randomization. The primary endpoints are safety and ORR (overall response rate) evaluated by the investigator in phase II study, and PFS evaluated by IRC (independent review committee) in phase III study. The primary hypothesis in phase III study is that HX008+pemetrexed+platinum is non-inferior to pembrolizumab+pemetrexed+platinum in terms of PFS (Progression-Free Survival).

Conditions

• Nonsquamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HX008	HX008 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 35 cycles
DRUG	Pembrolizumab	Pembrolizumab 200 mg intravenously (IV) on Day 1 of Q3W for up to 35 cycles
DRUG	pemetrexed	pemetrexed 500 mg/m\^2 IV on Day 1 of Q3W for up to 35 cycles
DRUG	cisplatin/carboplatin	cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of Q3W for 4 cycles

Timeline

• Start date: 2020-09-25
• Primary completion: 2022-09-25
• Completion: 2023-09-25
• First posted: 2021-02-11
• Last updated: 2021-02-11

Locations

10 sites across 1 country: China