Actively Recruiting
A Phase Ib/III Study Evaluating Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-20117 Combined With Aumolertinib in 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
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, how the body processes, and immune response to HS-20117 combined with Aumolertinib in adults with advanced non-squamous non-small cell lung cancer (NSCLC) that has specific EGFR mutations. This study is a Phase Ib/III clinical trial involving participants with newly diagnosed, locally advanced or metastatic NSCLC who have not received prior treatment for this condition. The goal is to determine the recommended dose and confirm the benefits and safety of combining these two drugs compared to Aumolertinib alone. The study has two phases: Phase Ib involves giving HS-20117 by intravenous infusion once during the first 28-day cycle and every two weeks in subsequent cycles, alongside daily oral doses of Aumolertinib at 110 mg. After safety and dose confirmation, Phase III will randomly assign participants to receive either the combination of HS-20117 and Aumolertinib or Aumolertinib alone, with all treatments continuing in 28-day cycles. Participants will undergo assessments including tumor imaging to measure response and progression, blood tests to study drug levels and immune reactions, and monitoring for side effects throughout treatment, which may last up to approximately 40 months. The study will track outcomes such as response rates, progression-free survival, overall survival, and adverse events. Safety follow-up will continue for at least 90 days after the final dose, and the total observation may extend to about 60 months.
CONDITIONS
Brief 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...
- Males or females aged 18 to 75 years (inclusive)
- Newly diagnosed, histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB/IIIC/IV) that is treatment naive
- Not suitable for curative therapy including surgery or chemoradiation
- Agree to provide fresh or archival tumor tissue
- At least one target lesion according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Minimum life expectancy greater than 12 weeks
- Agree to use adequate contraceptive measures during the study if applicable
- Females must not be pregnant and have evidence of 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 local therapy within washout period before first study drug dose
- Presence of pleural effusion or ascites requiring clinical intervention, or pericardial effusion
- Use of other 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 malignancies
- Untreated or active central nervous system metastases
- Inadequate bone marrow or organ function
- Severe, uncontrolled, or active cardiovascular disorders
- Severe or uncontrolled systemic diseases
- Severe bleeding symptoms or tendencies
- History of severe 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 who are pregnant, lactating, or planning pregnancy or breastfeeding during the study or within 6 months after last dose
- History of severe allergic or infusion reactions
- Any condition compromising safety or study assessment as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive HS-20117 by IV infusion once during the first 28-day cycle and once every 2 weeks in subsequent cycles, combined with daily oral Aumolertinib. The treatment continues until disease progression or withdrawal from the study.
Visits every 2 weeks for infusion and daily oral medication
Duration - Up to 90 days after last dose
Participants are monitored for safety, efficacy, and immunogenicity for up to 90 days after the final dose.
Approximately 1 to 3 visits during follow-up
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
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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