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

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

Recruiting
18-80 years
All
Phase 2

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Overview

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.

Eligibility

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

Study details
    Solid Tumor

NCT07003321

Jiangsu HengRui Medicine Co., Ltd.

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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