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

NCT07003321 | Recruiting Phase 2

• 1 other identifier: HRS-4508-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

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

  2 years

• Objective response rate (ORR)

  1 year

Secondary Outcomes (5)

• Blood concentrations of HRS-4508

  12 weeks

• Duration of response (DoR)

  1 year

• Disease control rate (DCR)

  1 year

• Progression free survival (PFS)

  1 year

• Overall survival (OS)

  2 years

Study Arms (1)

HRS-4508 tablet

EXPERIMENTAL

Drug: HRS-4508 tablet

Interventions

HRS-4508 tablet DRUG

HRS-4508 tablet

HRS-4508 tablet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Liju Zong

CONTACT

0518-82342973; liju.zong@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-05

Locations

CN (1)