Tests HS-20122 combined with other drugs in advanced lung cancer
Tests HS-20122 with other drugs in adults with advanced non-small cell lung cancer.
Key facts
- Who runs it
- Hansoh BioMedical R&D Company
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 396 people, planned
- Started
- 15 Jun 2026
- Expected to end
- 30 Apr 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- HS-20122+Aumolertinib
- HS-20122+Adbrelimab
- HS-20122+Adbrelimab+Platinum-based Chemo
- Record updated
- 6 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer who are new to treatment or have had at least 1 line of standard treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer (NSCLC), with at least 1 target lesion by RECIST 1.1.
- Earlier treatment
- Had at least 1 line of standard treatment, or no treatment yet. Enough time must have passed since earlier cancer drug treatment.
Main reasons for not taking part
- Brain metastasis or carcinomatous meningitis
- History of other primary cancers
- Active or uncontrolled heart disease
- Past or current interstitial lung disease (ILD)
- Known active infectious disease or a severe infection within 4 weeks
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Locally advanced or metastastic NSCLC
- Received at least 1 line SoC,or treatment naïve
- With at least 1 target lesion according to RECIST 1.1
- Appropriate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose
- Minimum expected survival longer than 12 weeks
- Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose
- Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form
Who cannot take part
- Insufficient wash out duration of prior systemic anticancer therapy
- Local radiotherapy within 2 weeks prior to first dose of investigational drug
- Major surgery within 4 weeks prior to first dose of investigational drug
- Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity)
- Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose
- Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose
- History of systemic glucocorticoids over 28 days prior to first dose of investigational drug
- Prensence of ophthalmological abnormalities; 17.Presence of hepatic encephalopathy, Hepato-renal Syndrome 18.Presence or history of confirmed or suspected ILD; 19.Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder; 20.History of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs; 21.Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator
- History of other primary malignancies
- Significant, uncontrolled, or active cardiovascular diseases
- Severe or poorly controlled diabetes
- Severe infection within 4 weeks
- Presence of known active infectious diseases,
- History of drugs may prolong QT interval
- Pleural/abdominal effusion requires clinical intervention
- Presence of brain metastasis or carcinomatous meningtitis
- Extremely obesity or emaciation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Ethics Committee of Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Ran Xu, MDTaking people
About the trial
What the trial wants to find out
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
The 3 groups in the trial
- HS-20122+AumolertinibTreatment being tested
- HS-20122+AdbrelimabTreatment being tested
- HS-20122+Adbrelimab+Platinum-based ChemoTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A PHASE Ib STUDY OF THE SAFETY, EFFICACY, PHARMACOKINETICS, AND IMMUNOGENICITY OF HS-20122 COMBINED THERAPY IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS
- Plain-language title
- Tests HS-20122 combined with other drugs in advanced lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07645222, who can take part
- Record updated
- 6 July 2026