Solid TumorPhase 2NCT07003321
A Trial of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing HRS-4508 tablet in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HRS-4508 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to Jul 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 80 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren
About this study
Official title: Study on Efficacy and Safety of HRS-4508 in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
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.
- Conditions
- Solid Tumor
- Being tested
- HRS-4508 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4508 tabletDrug
HRS-4508 tablet
| Study group | Role | What they receive |
|---|---|---|
| HRS-4508 tablet | Experimental | Not described Receives: Drug: HRS-4508 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Measured: 2 years
Objective response rate (ORR)
Measured: 1 year
Secondary outcomes (5)
Blood concentrations of HRS-4508
Measured: 12 weeks
Duration of response (DoR)
Measured: 1 year
Disease control rate (DCR)
Measured: 1 year
Progression free survival (PFS)
Measured: 1 year
Overall survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start12 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003321
- Sponsor's protocol ID
- HRS-4508-201
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided