Can a new pill outperform chemotherapy for a Hard-to-Treat lung cancer mutation?
NCT ID NCT07754123
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing whether an experimental oral drug, HS-10504, can slow the progression of advanced non-small cell lung cancer in people whose tumors carry a specific EGFR C797S mutation and have already failed prior EGFR inhibitor therapy. Participants will be randomly assigned to receive either HS-10504 or standard platinum-based chemotherapy. The study aims to see if the new drug offers better control of the disease and potentially improves survival.
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 tablet
- What this could lead to
- If successful, HS-10504 could offer a new targeted treatment option for people with a specific lung cancer mutation that has stopped responding to current therapies.
- What could go wrong
- This is an early-stage trial, and the drug may not prove more effective or safer than standard chemotherapy. Side effects are possible, and results may not apply to all patients.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 206 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
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 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV). 3. Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation. 4. At least one measurable target lesion per RECIST v1.1 criteria. Exclusion Criteria: 1. Presence of other well-documented driver gene mutations (e.g., ALK fusion, ROS1 fusion, KRAS activating mutations, MET exon 14 skipping, HER2 mutations, RET fusion). 2. Histological or phenotypic transformation (e.g., NSCLC to SCLC transformation, epithelial-to-mesenchymal transition) confirmed by tumor tissue obtained within 6 months prior to first dose. 3. ≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity). 4. History of other primary malignancies. 5. Inadequate bone marrow reserve or hepatic/renal organ function. 6. Clinically significant cardiac abnormalities or severe/uncontrolled/active cardiovascular disease. 7. Poorly controlled diabetes mellitus or hypertension. 8. Significant clinical bleeding tendency or history of severe arterial/venous thromboembolic events. 9. Severe or uncontrolled active infection. 10. Continuous systemic corticosteroid therapy (\>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use. 11. Active infectious diseases (e.g., active hepatitis B virus \[HBV\] infection). 12. Clinically significant gastrointestinal disorders. 13. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B. 14. Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity. 15. History of severe neurological or psychiatric disorders.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.