RecruitingPhase 2Phase 3NCT06417008

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer


Sponsor

Hansoh BioMedical R&D Company

Enrollment

1,080 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of two drugs — HS-20117 and aumolertinib — as a first-line treatment for advanced lung cancer (non-squamous NSCLC) that has a specific genetic mutation in a gene called EGFR. These drugs work by targeting the cancer's growth signals. **You may be eligible if...** - You are 18–75 years old - You have been newly diagnosed with advanced or metastatic non-small cell lung cancer with a sensitive EGFR mutation - You have not yet received any treatment for your advanced lung cancer - You have at least one measurable tumor on scans - Your general health is good (ECOG 0 or 1) - Your life expectancy is more than 12 weeks - You are willing to use contraception if applicable **You may NOT be eligible if...** - You have previously received MET-targeted therapy or EGFR antibody treatments - You have significant fluid build-up around your lungs or heart requiring treatment - You have significant side effects from prior cancer therapy - You have another primary cancer in your history (with some exceptions) 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

DRUGHS-20117

Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)

DRUGAumolertinib

110 mg orally once daily.


Locations(2)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06417008


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