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Recruiting NCT07003321

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

Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-4508 tablet.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug HRS-4508 tablet
    HRS-4508 tablet

Primary outcome measures

  • The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) [Time frame: 2 years]
  • Objective response rate (ORR) [Time frame: 1 year]
Secondary outcome measures (5)
  • Blood concentrations of HRS-4508 [Time frame: 12 weeks]
  • Duration of response (DoR) [Time frame: 1 year]
  • Disease control rate (DCR) [Time frame: 1 year]
  • Progression free survival (PFS) [Time frame: 1 year]
  • Overall survival (OS) [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Pulmonary Hospital — Shanghai

Identifiers

NCT: NCT07003321 · HRS-4508-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗