Lung CancerPhase 2NCT07232849
A Trial of HRS-4508 Combined With Other Antitumor Therapies in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing HRS-4508 tablet in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- HRS-4508 tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 4 Dec 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Tumor Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200430
Shun Lu
About this study
Official title: 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
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies 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
- Lung Cancer
- Being tested
- HRS-4508 tablet
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4508 tabletDrug
PartA ：HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB：HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC：HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose
| Study group | Role | What they receive |
|---|---|---|
| Part A/B/C | Experimental | PartA：HRS-4508 tablet+SHR-A1811 PartB：HRS-4508 tablet+ Adebrelimab Injection PartC：HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection Receives: Drug: HRS-4508 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: 2 month
Maximum tolerated dose (MTD)
Measured: 2 month
Determine dose recommendation (RP2D)
Measured: 6month
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Measured: 1 years
Objective response rate (ORR)
Measured: 1 year
Secondary outcomes (5)
Blood concentrations of HRS-4508 and SHR-A1811
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 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start4 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- 100 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
- NCT07232849
- Sponsor's protocol ID
- HRS-4508-202-LC
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07232849
- Acronym / sponsor ID
- HRS-4508-202-LC
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combined with other antitumor therapies 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A/B/C | Experimental | Drug: HRS-4508 tabletPartA：HRS-4508 tablet+SHR-A1811 PartB：HRS-4508 tablet+ Adebrelimab Injection PartC：HRS-4508 tablet+SHR-A1811+ Adebrelimab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 to 75 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-4508 tabletPartA ：HRS-4508 tablet fixed dose+SHR-A1811 fixed dose PartB：HRS-4508 tablet fixed dose + Adebrelimab Injection fixed dose PartC：HRS-4508 tablet fixed dose +SHR-A1811 fixed dose + Adebrelimab Injection fixed dose | Drug | Part A/B/C |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 2 month
Maximum tolerated dose (MTD)
Time frame: 2 month
Determine dose recommendation (RP2D)
Time frame: 6month
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)
Time frame: 1 years
Objective response rate (ORR)
Time frame: 1 year
5 secondary outcomes
Blood concentrations of HRS-4508 and SHR-A1811
Time frame: 12 weeks
Duration of response (DoR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4508 tablet in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liju Zong (+86-15821860817, liju.zong@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 2 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.