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NCT Number: NCT07003321

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

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.

Recruiting

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Shengxiang Ren

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

HRS-4508 tablet

Drug

HRS-4508 tablet

Primary outcomes

  1. The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)

    Time frame: 2 years

  2. Objective response rate (ORR)

    Time frame: 1 year

Secondary outcomes

  1. Blood concentrations of HRS-4508

    Time frame: 12 weeks

  2. Duration of response (DoR)

    Time frame: 1 year

  3. Disease control rate (DCR)

    Time frame: 1 year

  4. Progression free survival (PFS)

    Time frame: 1 year

  5. Overall survival (OS)

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Liju Zong

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 4, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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