MedTrace Logo

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

NCT04750083 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2021-02-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Taizhou Hanzhong biomedical co. LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2022-09-25
Completion
2023-09-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750083 on ClinicalTrials.gov