Locally Advanced or Metastatic Non-small Cell Lung CancerPhase 2NCT07175220
Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
A Phase 2 study testing SHR2554; SHR-A2102, SHR2554; Adabelimumab and SHR2554; SHR-1701 in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Non-small Cell Lung Cancer
- What is being tested?
- SHR2554; SHR-A2102, SHR2554; Adabelimumab and SHR2554; SHR-1701
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to Oct 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 range of 18-75 years old (including both ends), gender not limited;
- Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
- ECOG score is 0 or 1
- Expected survival period ≥ 12 weeks
- Has a good level of organ function
- Patients voluntarily joined the study and signed informed consent
Who cannot join
- Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc
- Symptomatic or active central nervous system tumor metastasis
- Previously or simultaneously suffering from other malignant tumors
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy
- Accompanied by uncontrolled tumor related pain
- Plan to receive any other anti-tumor treatment during this trial period
Show all 20Show fewer
- Receive other anti-tumor treatments within 4 weeks before the first medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
- Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study
- Moderate to severe pleural effusion with clinical symptoms
- Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
- Subjects who have experienced severe infections within 30 days prior to their first medication use
- Administer attenuated live vaccine within 30 days before the first use of medication.
- History of immunodeficiency
- Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
- History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
- AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
- Untreated active hepatitis
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- There are other serious physical or mental illnesses or laboratory abnormalities present
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang
About this study
Official title: A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
- Being tested
- SHR2554; SHR-A2102, SHR2554; Adabelimumab, SHR2554; SHR-1701
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2554; SHR-A2102Drug
SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days
SHR2554; AdabelimumabDrug
SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days
SHR2554; SHR-1701Drug
SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Queue A | Experimental | Not described Receives: Drug: SHR2554; SHR-A2102 |
| Queue B | Experimental | Not described Receives: Drug: SHR2554; Adabelimumab |
| Queue C | Experimental | Not described Receives: Drug: SHR2554; SHR-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Measured: 21days after the first administration of each subject
AE
Measured: from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE)
Measured: from Day1 to 30 days after last dose
ORR
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary outcomes (5)
Immunogenic indicators: anti-SHR-A2102 antibody (ADA)
Measured: through study completion, an average of 2 years
Duration of response (DoR)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start9 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-small Cell 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT07175220
- Sponsor's protocol ID
- SHR2554-203-LC
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 18 Nov 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07175220
- Acronym / sponsor ID
- SHR2554-203-LC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Sep 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.
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Queue A | Experimental | Drug: SHR2554; SHR-A2102 |
| Queue B | Experimental | Drug: SHR2554; Adabelimumab |
| Queue C | Experimental | Drug: SHR2554; SHR-1701 |
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 range of 18-75 years old (including both ends), gender not limited;
- Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
- ECOG score is 0 or 1
- Expected survival period ≥ 12 weeks
- Has a good level of organ function
Key exclusion criteria (20 listed)
- Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc
- Symptomatic or active central nervous system tumor metastasis
- Previously or simultaneously suffering from other malignant tumors
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy
- Accompanied by uncontrolled tumor related pain
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 |
|---|---|---|
| SHR2554; SHR-A2102SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days | Drug | Queue A |
| SHR2554; AdabelimumabSHR2554 tablets combined with Adabelimumab, with a cycle of 21 days | Drug | Queue B |
| SHR2554; SHR-1701SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days | Drug | Queue C |
Primary outcome
DLT
Time frame: 21days after the first administration of each subject
AE
Time frame: from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE)
Time frame: from Day1 to 30 days after last dose
ORR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
5 secondary outcomes
Immunogenic indicators: anti-SHR-A2102 antibody (ADA)
Time frame: through study completion, an average of 2 years
Duration of response (DoR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
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 18 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR2554; SHR-A2102, SHR2554; Adabelimumab and SHR2554; SHR-1701 in people with Locally Advanced or Metastatic Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 20 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiaoxue Pi (0518-82342973, Xiaoxue.pi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 21days after the first administration of each subject). The study lists 4 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 18 Nov 2025.