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

NCT07232849 | Recruiting Phase 2

• 1 other identifier: HRS-4508-202-LC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (5)

• 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

• Objective response rate (ORR)

  1 year

Secondary Outcomes (5)

• Blood concentrations of HRS-4508 and SHR-A1811

  12 weeks

• Duration of response (DoR)

  1 year

• Disease control rate (DCR)

  1 year

• Progression free survival (PFS)

  1 year

• Overall survival (OS)

  2 year

Study Arms (1)

Part A/B/C

EXPERIMENTAL

PartA：HRS-4508 tablet+SHR-A1811 PartB：HRS-4508 tablet+ Adebrelimab Injection PartC：HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection

Drug: HRS-4508 tablet

Interventions

HRS-4508 tablet DRUG

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

Part A/B/C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 75 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 (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200430, China

RECRUITING

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Liju Zong

CONTACT

+86-15821860817; 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: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-08

Locations

CN (2)