NCT07169552

HC010 in First-line PD-L1 Positive Advanced NSCLC Patients

A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: HC Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection in patients with positive PD-L1 (TPS ≥1%)

Detailed description

This is a multicenter, single-arm, open-label Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection as monotherapy in first-line treatment of locally advanced or metastatic non-small cell lung cancer with positive PD-L1 (TPS ≥1%), negative EGFR mutations and negative ALK.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	HC010	HC010 Q3W intravenous infusion

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-12-30
• Completion: 2027-09-30
• First posted: 2025-09-11
• Last updated: 2025-12-17

Locations

1 site across 1 country: China