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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Liju Zong
• Email: liju.zong@hengrui.com
• Phone: 0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.