Health TrialsbyHealthPanel

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

ConditionAdvanced or Metastatic NSCLC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: HS-10504 groupExperimental treatment 1 intervention
Group B: Platinum-Based Doublet Chemotherapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Progression Free Survival (PFS) as assessed by Blinded independent Central Review (BICR) per RECIST 1.1

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.

Secondary outcomes

1

Overall Survival (OS)

Overall survival (OS)

Time frame
Start of study drug to Survival Endpoint through study completion, an average of 3 years.
2

PFS

PFS assessed by Investigator assessment per RECIST 1.1

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.
3

ORR

Confirmed ORR by BICR and Investigator per RECIST 1.1

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.
4

DoR

DoR by BICR and Investigator per RECIST 1.1

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: