Actively Recruiting
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
Led by Hansoh BioMedical R&D Company · Updated on 2025-08-01
1080
Participants Needed
2
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years inclusive
- Newly diagnosed, histologically or cytologically confirmed locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB/IIIC/IV), treatment naive
- Not suitable for curative therapy including surgery or chemoradiation
- Willing to provide fresh or archival tumor tissue
- At least one target lesion per RECIST v1.1
- ECOG performance status of 0-1
- Minimum life expectancy greater than 12 weeks
- Using adequate contraceptive measures throughout the study (males and females)
- Females not pregnant at screening and with non-childbearing potential
- Signed informed consent form
You will not qualify if you...
- Prior or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates
- Use of traditional Chinese medicine for tumors, major surgery, or other local therapy within washout period before first dose
- Presence of pleural effusion or ascites requiring clinical intervention; presence of pericardial effusion
- Use of investigational non-anti-tumor drugs, strong CYP3A4 inhibitors or inducers, drugs sensitive to BCRP or P-gp, or drugs that prolong QT interval within washout period
- Grade 2 or higher toxicities from prior anti-tumor therapy
- History of other primary cancers
- Untreated or active central nervous system metastases
- Inadequate bone marrow or organ function
- Severe, uncontrolled or active cardiovascular, systemic diseases, bleeding disorders, or arteriovenous thrombosis
- Serious or active infections or infectious diseases
- Interstitial lung disease
- Serious neurological or mental disorders
- History of hypersensitivity to HS-20117, Aumolertinib, or similar drugs
- Female subjects pregnant, lactating, or planning pregnancy or breastfeeding during or within 6 months after treatment
- History of severe allergic or infusion reactions
- Any condition compromising safety or study assessments as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jialei Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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