A Trial of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Study on Efficacy and Safety of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07003321

Enrollment

120

Registered

2025-06-04

Start date

2025-09-12

Completion date

2028-07-31

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.

Interventions

DRUGHRS-4508 tablet

HRS-4508 tablet

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age: 18 to 80 years old; Both men and women are welcome; 2. Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens. 3. ECOG ratings of 0 or 1. 4. Expected survival period ≥ 12 weeks. 5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition. 6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Exclusion criteria

1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis 2. There have been significant severe infections and major surgeries in the past 4 weeks 3. Existence of previous or concurrent malignant tumors 4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication 5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery within 7 days prior to the first administration of medication

Design outcomes

Primary

Measure	Time frame
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)	2 years
Objective response rate (ORR)	1 year

Secondary

Measure	Time frame
Blood concentrations of HRS-4508	12 weeks
Duration of response (DoR)	1 year
Overall survival (OS)	2 years
Progression free survival (PFS)	1 year
Disease control rate (DCR)	1 year

Countries

China

Contacts

Primary ContactLiju Zong

liju.zong@hengrui.com0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026