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NCT Number: NCT07754123

Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC

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.

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Key information

Conditions

Advanced or Metastatic NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.
  • 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.

Treatment and study plan

HS-10504

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Start of study drug to Survival Endpoint through study completion, an average of 3 years.

    Overall survival (OS)

  2. 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.

    PFS assessed by Investigator assessment per RECIST 1.1

  3. 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.

    Confirmed ORR by BICR and Investigator per RECIST 1.1

  4. 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.

    DoR by BICR and Investigator per RECIST 1.1

  5. 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.

    DCR by BICR and Investigator per RECIST 1.1

  6. 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.

    AE assessed by investigators.

  7. 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.

    SAE assessed by investigators.

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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