> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1b-study-of-hs-20122-combined-therapy-in-nsclc-831c81f7-8f15-411f-8ce8-c0516e56c449 > Record changed: 2026-10-13 # PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC NCT07645222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Participants 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Lead sponsor Hansoh BioMedical R&D Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Start date 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Short title** PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Dates **Completion date** 2029-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **First posted** 2026-06-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Registry last updated** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Primary completion date** 2028-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Start date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Size and sites **Participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Planned participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Lead sponsor** Hansoh BioMedical R&D Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Identifiers **Registry ID** NCT07645222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **ClinicalTrials.gov ID** NCT07645222 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Outcomes ### Primary outcomes 1. RP2D for Combination Timeframe: Through the full duration of this trial, approximately 2 years To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-20122 based therapy in subjects with locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial 2. ORR Timeframe: Through the full duration of this trial, approximately 2 years； Investigator evaluated overall response rate, to evaluate the efficacy of each combination; 3. TEAE Timeframe: Through the full duration of this trial, approximately 2 years； incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0 4. TRAE Timeframe: Through the full duration of this trial, approximately 2 years； incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0 5. SAE Timeframe: Through the full duration of this trial, approximately 2 years incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0 ### Secondary outcomes 1. Duration of Response Timeframe: Through the full duration of this trial ,approximately 2 years Investigator evaluated Duration of Response 2. Disease Control Rate Timeframe: Through the full duration of this trial ,approximately 2 years； Investigator evaluated Disease Control Rate 3. Progression Free Survival Timeframe: Through the full duration of this trial, approximately 2 years； Investigator evaluated duration of Progression Free Survival 4. Overall Survival Timeframe: Through the full duration of this trial ,approximately 2 years； Investigator evaluated duration of Overall Survival 5. PK parameter Timeframe: Through the full duration of this trial, approximately 2 years； blood concentration of combo agents 6. Immuogencity Timeframe: Through the full duration of this trial ,approximately 2 years； positive rate of drug specific antibody Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Locally advanced or metastastic NSCLC; 2. Received at least 1 line SoC,or treatment naïve; 3. With at least 1 target lesion according to RECIST 1.1. 4. Appropriate organ function 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose. 6. Minimum expected survival longer than 12 weeks 7. 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. 8. Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form. ### Exclusion criteria 1. Insufficient wash out duration of prior systemic anticancer therapy 2. Local radiotherapy within 2 weeks prior to first dose of investigational drug 3. Pleural/abdominal effusion requires clinical intervention 4. Major surgery within 4 weeks prior to first dose of investigational drug 5. History of drugs may prolong QT interval 6. 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). 7. Presence of brain metastasis or carcinomatous meningtitis 8. History of other primary malignancies 9. Significant, uncontrolled, or active cardiovascular diseases 10. Severe or poorly controlled diabetes 11. Extremely obesity or emaciation 12. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose 13. Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose 14. Severe infection within 4 weeks 15. History of systemic glucocorticoids over 28 days prior to first dose of investigational drug 16. Presence of known active infectious diseases, 17. 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Sites - Ethics Committee of Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07645222) ## Related records ### Drugs (2) - [Aumolertinib](https://trialight.com/data/asset/aumolertinib-1339ec2f-ba43-4359-aaa7-6a9516518faa.md) - [Platinum](https://trialight.com/data/asset/platinum-418ce0fe-dd28-40a8-8225-5d12ccc291d1.md) ### Lead sponsors (1) - [Hansoh BioMedical R&D Company](https://trialight.com/data/company/hansoh-biomedical-r-d-company-e6d6662a-6212-498b-9d6d-765fcd3d7749.md) ### Conditions (2) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Primary condition - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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