Non-Small Cell Lung CancerPhase 2NCT07489716
A Phase II Clinical Trial of SHR-1826 for Non-Small Cell Lung Cancer
A Phase 2 study testing SHR-1826 in people with Non-Small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating 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
- Non-Small Cell Lung Cancer
- What is being tested?
- SHR-1826
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2026to 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
- Aged 18-75 years
- ECOG performance status score of 0 or 1;
- Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
- Participants must provide archived or fresh tumor tissue;
- Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
- At least one measurable lesion according to RECIST v1.1 criteria;
- Expected survival ≥3 months;
- Adequate organ function;
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- History of or concurrent other malignancies;
- Untreated spinal cord compression ;
- Uncontrolled tumor-related pain;
- Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
- History of interstitial lung disease;
- Severe cardiovascular/cerebrovascular diseases;
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
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu
About this study
Official title: A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SHR-1826
- 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.
SHR-1826Drug
SHR-1826
| Study group | Role | What they receive |
|---|---|---|
| SHR-1826 | Experimental | Not described Receives: Drug: SHR-1826 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR assessed by IRC according to RECIST v1.1 s）
Measured: once every 6 weeks, estimated 2 years
Secondary outcomes (5)
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
Measured: once every 6 weeks, estimated 2 years
Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
Measured: once every 6 weeks, estimated 2 years
Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;
Measured: once every 6 weeks, estimated 2 years
Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;
Measured: Estimated 2 years
Overall Survival (OS).
Measured: Estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start29 Apr 2026
- Primary completionAug 2028 (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 Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489716
- Sponsor's protocol ID
- SHR-1826-205
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07489716
- Acronym / sponsor ID
- SHR-1826-205
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1826 | Experimental | Drug: SHR-1826 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-75 years
- ECOG performance status score of 0 or 1;
- Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
- Participants must provide archived or fresh tumor tissue;
- Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
Key exclusion criteria (7 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- History of or concurrent other malignancies;
- Untreated spinal cord compression ;
- Uncontrolled tumor-related pain;
- Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
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 |
|---|---|---|
| SHR-1826SHR-1826 | Drug | SHR-1826 |
Primary outcome
ORR assessed by IRC according to RECIST v1.1 s）
Time frame: once every 6 weeks, estimated 2 years
5 secondary outcomes
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: once every 6 weeks, estimated 2 years
Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;
Time frame: Estimated 2 years
Overall Survival (OS).
Time frame: Estimated 2 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 13 May 2026.
- 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 SHR-1826 in people with Non-Small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals 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 8 inclusion and 7 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 13 May 2026. 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 Yijun Jia (+0518-81220121, Yijun.jia@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR assessed by IRC according to RECIST v1.1 s） (time frame: once every 6 weeks, estimated 2 years). 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 13 May 2026.