PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC (NCT07645222) | Clinical Trial Compass
Not Yet RecruitingPhase 1
PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC
396 participantsStarted 2026-06-30
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Insufficient wash out duration of prior systemic anticancer therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1b trial that hasn't started recruiting yet — given that it's still in the earliest phase of testing this combination, what is currently known about the safety profile of HS-20122, and how does that uncertainty compare to my other treatment options right now?
2Since one of the main goals of this trial is to find the right dose of the combination therapy — called the RP2D — does that mean my dose could be adjusted during the study, and how might that affect me practically?
3The trial is tracking serious adverse events and treatment-related adverse events as primary outcomes, which tells me safety is still being established — based on my specific health situation, do you think the potential risks of joining an early-phase study like this are reasonable for me to consider?
4Since this trial isn't recruiting yet, how long do you think it might realistically be before I could even be considered for enrollment, and should I be pursuing another treatment in the meantime rather than waiting?
5Are there currently approved or standard treatments for my type of non-small cell lung cancer that I should try first, and under what circumstances would joining a Phase 1b combination study like this make more sense than those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RP2D for Combination
Timeframe: Through the full duration of this trial, approximately 2 years
2
ORR
Timeframe: Through the full duration of this trial, approximately 2 years；
3
TEAE
Timeframe: Through the full duration of this trial, approximately 2 years；
4
TRAE
Timeframe: Through the full duration of this trial, approximately 2 years；
5
SAE
Timeframe: Through the full duration of this trial, approximately 2 years
. Major surgery within 4 weeks prior to first dose of investigational drug
. History of drugs may prolong QT interval
. 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).
. Presence of brain metastasis or carcinomatous meningtitis