RecruitingPhase 2NCT07232849

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

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

100 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • Age: 18 to 75 years old; Both men and women are welcome;
  • Locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens.
  • ECOG ratings of 0 or 1.
  • Expected survival period ≥ 12 weeks.
  • At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
  • Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Exclusion Criteria5

  • Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
  • There have been significant severe infections and major surgeries in the past 4 weeks
  • Existence of previous or concurrent malignant tumors
  • Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
  • 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

Interventions

DRUGHRS-4508 tablet

PartA :HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB:HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC:HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose


Locations(2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, China

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NCT07232849


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