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NCT05787613
PHASE2

A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients

Sponsor: Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Official title: A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-07-10

Completion Date

2027-07

Last Updated

2025-08-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

HLX26

Anti-LAG-3 monoclonal Antibody Injection

DRUG

Serplulimab

anti-PD-1 humanized monoclonal antibody injection

DRUG

Chemotherapy drug

non-squamous NSCLC patients will receive Pemetrexed 500mg/m2, IV, Q3W. Carboplatin AUC 5mg/mL/min, IV, Q3W, up to 4 cycles.squamous NSCLC patients will receive Albumin-paclitaxel 100mg/m2, IV, Q1W or paclitaxel 175mg/m2, IV, Q3W and carboplatin AUC 5 mg/mL/min, IV, Q3W, up to 4 cycles.

DRUG

Placebo

placebo

Locations (3)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China