HS-10504 compared with chemotherapy for advanced lung cancer with an EGFR C797S mutation
Compares HS-10504 with chemotherapy in adults with advanced non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
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 lung cancer (NSCLC) that has spread or grown locally, carries the EGFR C797S mutation, and stopped responding to EGFR TKI treatment.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, locally advanced or metastatic (Stage IIIB, IIIC or IV), confirmed by tissue or cell tests, with at least one measurable tumour lesion (RECIST v1.1).
- Earlier treatment
- Must have had at least 1 earlier line of EGFR TKI treatment that stopped working.
- Biomarker or test result
- EGFR C797S mutation, found together with the failure of EGFR TKI treatment.
Main reasons for not taking part
- Other well-documented driver gene changes (for example ALK, ROS1, KRAS, MET exon 14 skipping, HER2, RET)
- Tumour changed type (for example into small cell lung cancer), confirmed within 6 months before the first dose
- Side effects of grade 2 or higher from earlier cancer treatment (not hair loss or stable nerve damage)
- Another primary cancer in the past
- Severe or uncontrolled heart disease, infection (including active hepatitis B), or poorly controlled diabetes or high blood pressure
Read by machine on 9 November 2026.
Where in China
- Guangzhou Medical UniversityGuangzhou, ChinaTaking people
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 doctorTrial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07754123
- Record updated
- 2 November 2026
- Original description
This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.Read full original descriptionShow less
A Randomized, Controlled, Open-Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR C797S Mutation After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.
Inclusion: Age ≥18 years; Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV); Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation; At least one measurable target lesion per RECIST v1.1 criteria.
Exclusion: 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; ≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity); Continuous systemic corticosteroid therapy (>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use; History of other primary malignancies; Clinically significant cardiac abnormalities or severe/uncontrolled/active cardiovascular disease; Poorly controlled diabetes mellitus or hypertension; Significant clinical bleeding tendency or history of severe arterial/venous thromboembolic events; Severe or uncontrolled active infection; Active infectious diseases (e.g., active hepatitis B virus [HBV] infection); Clinically significant gastrointestinal disorders; Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B; Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity; History of severe neurological or psychiatric disorders; 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); Inadequate bone marrow reserve or hepatic/renal organ function.