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

Study on Efficacy and Safety of HRS-4508 Combined With Other Antitumor Therapies 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 combined with other antitumor therapies 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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: HRS-4508 tablet

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liju Zong; Phone Number: +86-15821860817; Email: liju.zong@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200430
      • Recruiting
      • Shanghai Chest Hospital
      • Principal Investigator: Shun Lu
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Tumor Hospital
      • Principal Investigator: Zhengbo Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 18 to 75 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A/B/C; PartA：HRS-4508 tablet+SHR-A1811 PartB：HRS-4508 tablet+ Adebrelimab Injection PartC：HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection	Drug: HRS-4508 tablet; PartA ：HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB：HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC：HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR)	1 year
Dose limiting toxicity (DLT)	2 month
Maximum tolerated dose (MTD)	2 month
Determine dose recommendation (RP2D)	6month
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)	1 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	2 year
Progression free survival (PFS)	1 year
Disease control rate (DCR)	1 year
Duration of response (DoR)	1 year
Blood concentrations of HRS-4508 and SHR-A1811	12 weeks

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HRS-4508-202-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No