HRS-4508 for locally advanced or metastatic non-small cell lung cancer

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

This trial will test HRS-4508, an oral tablet, to see if it shrinks tumors or controls disease in adults with locally advanced or metastatic non-small cell lung cancer who have failed or cannot tolerate standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07003321 on ClinicalTrials.gov

What this trial studies

This is a phase 2, interventional trial of HRS-4508 given orally to adults with locally advanced or metastatic non-small cell lung cancer. The study will measure objective response rate (ORR), safety, and pharmacokinetics (PK) of HRS-4508 in participants with measurable extracranial disease and ECOG performance status 0–1. Key exclusions include untreated or active central nervous system metastases, recent major surgery or severe infection, concurrent other malignancies, and gastrointestinal conditions that prevent oral dosing. The trial is sponsored by Jiangsu HengRui Medicine Co., Ltd. and conducted at Shanghai Pulmonary Hospital.

Who should consider this trial

Good fit: Adults aged 18–80 with locally advanced or metastatic non-small cell lung cancer who have failed or cannot tolerate standard treatment, have ECOG 0–1, at least one measurable extracranial lesion, and can comply with follow-up are ideal candidates.

Not a fit: Patients with untreated or active brain metastases, recent major surgery or severe infections, concurrent other cancers, or serious gastrointestinal issues that prevent taking oral medication are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, HRS-4508 could provide a new oral treatment option that shrinks tumors or prolongs disease control for patients who have exhausted or cannot receive standard therapies.

How similar studies have performed: Oral small-molecule therapies have produced meaningful responses in certain NSCLC subgroups, but HRS-4508 is a novel agent that requires phase 2 data to determine its activity and safety profile.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Liju Zong

Conditions Solid Tumor