HRS-4508 combined with other antitumor therapies for 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

This test will try HRS-4508 together with other cancer treatments to see if it helps people with locally advanced or metastatic non-small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07232849 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial gives oral HRS-4508 tablets in combination with other antitumor therapies to adults with locally advanced or metastatic non-small cell lung cancer who have failed or cannot tolerate standard treatments. The trial will track objective response rate, overall safety and tolerability, and pharmacokinetic (PK) characteristics of HRS-4508 when used in combination. Eligible participants must have ECOG 0–1, at least one measurable lesion outside the central nervous system, and an expected survival of at least 12 weeks. The study is being conducted at Shanghai Chest Hospital and Zhejiang Tumor Hospital with regular imaging, laboratory monitoring, and protocol-driven follow-up visits.

Who should consider this trial

Good fit: Adults aged 18–75 with locally advanced or metastatic non-small cell lung cancer who have failed or cannot tolerate standard treatments, have ECOG 0–1, measurable disease outside the CNS, and expected survival ≥12 weeks.

Not a fit: Patients with untreated or active CNS metastases, recent major surgery or severe infections, concurrent other malignancies, or significant gastrointestinal problems preventing oral medication are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could shrink tumors or slow disease progression and offer a new option for patients who have exhausted standard therapies.

How similar studies have performed: Other trials combining targeted oral agents with standard therapies in NSCLC have shown benefit in selected patients, but HRS-4508 itself appears to be a novel agent with limited publicly available data so far.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhejiang Tumor Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Liju Zong

Conditions Lung Cancer