Advanced or Metastatic NSCLCPhase 3NCT07754123
Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC
A Phase 3 study testing HS-10504 and platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin) in people with Advanced or Metastatic NSCLC, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic NSCLC
- What is being tested?
- HS-10504 and platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2026to 31 Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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).
- History of other primary malignancies.
- Inadequate bone marrow reserve or hepatic/renal organ function.
- Clinically significant cardiac abnormalities or severe/uncontrolled/active cardiovascular disease.
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- Poorly controlled diabetes mellitus or hypertension.
- Significant clinical bleeding tendency or history of severe arterial/venous thromboembolic events.
- Severe or uncontrolled active infection.
- Continuous systemic corticosteroid therapy (>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Medical University
Guangzhou
Medical Ethics Committee of the First Affiliated Hospital of G, 020-81566265
About this study
Official title: 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.
- Conditions
- Advanced or Metastatic NSCLC
- Being tested
- HS-10504, platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10504Drug
HS-10504 tablet
platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)Drug
Participants will receive 4 cycles of standard platinum-based doublet chemotherapy (selected by the investigator based on participant's condition and tolerance):
- Option 1: Pemetrexed 500 mg/m² IV infusion + Cisplatin 75 mg/m² IV infusion on Day 1 of each 21-day cycle.
- Option 2: Pemetrexed 500 mg/m² IV infusion + Carboplatin AUC 5 IV infusion on Day 1 of each 21-day cycle.
- Substitution Rule: Cisplatin and carboplatin may be substituted if intolerable due to safety, while maintaining 4 total cycles of platinum-based therapy.
| Study group | Role | What they receive |
|---|---|---|
| HS-10504 group | Experimental | Not described Receives: Drug: HS-10504 |
| Platinum-Based Doublet Chemotherapy Group | Active comparator | Not described Receives: Drug: platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Secondary outcomes (7)
Overall Survival (OS)
Overall survival (OS)
Measured: Start of study drug to Survival Endpoint through study completion, an average of 3 years.
PFS
PFS assessed by Investigator assessment per RECIST 1.1
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
ORR
Confirmed ORR by BICR and Investigator per RECIST 1.1
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
DoR
DoR by BICR and Investigator per RECIST 1.1
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
DCR
DCR by BICR and Investigator per RECIST 1.1
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
AE
AE assessed by investigators.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
SAE
SAE assessed by investigators.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start23 Oct 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754123
- Sponsor's protocol ID
- HS-10504-301
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07754123
- Acronym / sponsor ID
- HS-10504-301
- Conditions
- Advanced or Metastatic NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10504 group | Experimental | Drug: HS-10504 |
| Platinum-Based Doublet Chemotherapy Group | Active comparator | Drug: platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
- 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).
- History of other primary malignancies.
- Inadequate bone marrow reserve or hepatic/renal organ function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10504HS-10504 tablet | Drug | HS-10504 group |
| platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)Participants will receive 4 cycles of standard platinum-based doublet chemotherapy (selected by the investigator based on participant's condition and tolerance): * Option 1: Pemetrexed 500 mg/m² IV infusion + Cisplatin 75 mg/m² IV infusion on Day 1 of each 21-day cycle. * Option 2: Pemetrexed 500 mg/m² IV infusion + Carboplatin AUC 5 IV infusion on Day 1 of each 21-day cycle. * Substitution Rule: Cisplatin and carboplatin may be substituted if intolerable due to safety, while maintaining 4 total cycles of platinum-based therapy. | Drug | Platinum-Based Doublet Chemotherapy Group |
Primary outcome
Progression Free Survival (PFS)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1
7 secondary outcomes
Overall Survival (OS)
Time frame: Start of study drug to Survival Endpoint through study completion, an average of 3 years.
PFS
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
ORR
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
DoR
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
DCR
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
AE
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
SAE
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-10504 and platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin) in people with Advanced or Metastatic NSCLC, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.