New cocktail of drugs takes on Hard-to-Treat lung cancer
NCT ID NCT07414953
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new oral drug called HS-10504 combined with several other drugs given by IV in people with advanced non-small cell lung cancer that has worsened after previous treatment. The study will enroll about 400 participants and aims to find safe doses and check whether the combinations shrink tumors. It is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-10504 (oral drug) combined with other drugs (SHR-A2009, HS-20122, HS-20117, SHR-1826, SHR-A2102) given by IV
- What this could lead to
- If successful, this could point toward a new combination treatment for advanced lung cancer that has stopped responding to prior therapy.
- What could go wrong
- This is a very early (Phase 1) trial focused on safety and dosing, not yet on effectiveness. The combinations may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Cohort1:participants with EGFR mutation advanced stage NSCLC,disease progression on or after prior treatment; * Cohort2:participants with MET position advanced stage NSCLC,disease progression on or after prior treatment; * 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 * Local radiotherapy within 2 weeks prior to first dose of investigational drug * Pleural/abdominal effusion requires clinical intervention * 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 * History of other primary malignancies * Significant, uncontrolled, or active cardiovascular diseases * Severe or poorly controlled diabetes * Extremely obesity or emaciation * 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 * Severe infection within 4 weeks * History of systemic glucocorticoids over 28 days prior to first dose of investigational drug * Presence of known active infectious diseases, * Presence of hepatic encephalopathy, Hepantorenal Syndrome * Presence or history of confirmed or suspected ILD; * Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder. * Past history of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs. * Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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