RecruitingPhase 2NCT07169552

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)


Sponsor

HC Biopharma Inc.

Enrollment

50 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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%)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing HC010 as a first-line (initial) treatment for people with advanced non-small cell lung cancer (NSCLC) whose tumors test positive for PD-L1 — a protein that makes cancer less visible to the immune system. HC010 is a new drug designed to work as an immunotherapy. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic (stage IIIb–IV) non-small cell lung cancer confirmed by biopsy - Your tumor tests positive for PD-L1 on a pathology test - You have not previously received systemic treatment for advanced or metastatic NSCLC (or your prior adjuvant/neoadjuvant treatment ended more than 6 months ago) **You may NOT be eligible if...** - Your tumor has targetable gene mutations (like EGFR, ALK, or ROS1 — different drugs work better for those) - You have active autoimmune disease or are on immune-suppressing medications - You have serious heart, lung, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHC010

HC010 Q3W intravenous infusion


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT07169552


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