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

NCT ID: NCT07003321

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-4508 tablet

Group Type EXPERIMENTAL

HRS-4508 tablet

Intervention Type DRUG

HRS-4508 tablet

Interventions

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HRS-4508 tablet

HRS-4508 tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 to 80 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liju Zong

Role: CONTACT

Phone: 0518-82342973

Email: [email protected]

Other Identifiers

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HRS-4508-201

Identifier Type: -

Identifier Source: org_study_id