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

Recruiting now · Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT07003321

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

120

Starts

2025-09-12

Expected to finish

2028-07-01

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 to 80 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.

You may not qualify if…

• 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

Where it is running

• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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