NSCLCPhase 2NCT06844474
A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC
A Phase 2 study testing SHR-1826；Adebrelimab；SHR-8068；Bevacizumab in people with NSCLC, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SHR-1826；Adebrelimab；SHR-8068；Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 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
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- ECOG performance score of 0-1.
- Life expectancy ≥ 3 months.
- Have at least one measurable tumor lesion per RECIST v1.1.
- Subjects with histologically confirmed locally advanced or metastatic NSCLC.
- Good level of organ function.
- Provide archived or fresh tumor tissue for vendor test.
Who cannot join
- Subjects with active central nervous system metastases or meningeal metastases;
- History of serious cardiovascular and cerebrovascular diseases;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- Severe infection within 4 weeks prior to the first dose;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- Subjects with uncontrolled tumor-related pain;
Show all 11Show fewer
- Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
- History of immunodeficiency, including a positive HIV test;
- Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
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
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100039
Yi Hu
About this study
Official title: A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.
- Conditions
- NSCLC
- Being tested
- SHR-1826；Adebrelimab；SHR-8068；Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1826；Adebrelimab；SHR-8068；BevacizumabDrug
Drug:
Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks.
Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks.
Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks.
Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | SHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection Receives: Drug: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)
Measured: approximately 2 years
Overall response rate (ORR)
Measured: approximately to 2 years
Secondary outcomes (4)
Duration of response (DoR)
Measured: approximately to 2 years
Disease control rate (DCR)
Measured: approximately to 2 years
Progression-free survival (PFS)
Measured: approximately to 2 years
Overall survival (OS)
Measured: approximately to 5 years after last subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start7 Mar 2025
- Primary completionDec 2026 (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 NSCLCStudies 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
- 300 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
- NCT06844474
- Sponsor's protocol ID
- SHR-1826-203
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC
- ClinicalTrials.gov ID
- NCT06844474
- Acronym / sponsor ID
- SHR-1826-203
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Feb 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.
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: SHR-1826；Adebrelimab；SHR-8068；BevacizumabSHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- ECOG performance score of 0-1.
- Life expectancy ≥ 3 months.
- Have at least one measurable tumor lesion per RECIST v1.1.
- Subjects with histologically confirmed locally advanced or metastatic NSCLC.
Key exclusion criteria (11 listed)
- Subjects with active central nervous system metastases or meningeal metastases;
- History of serious cardiovascular and cerebrovascular diseases;
- Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- Severe infection within 4 weeks prior to the first dose;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
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-1826；Adebrelimab；SHR-8068；BevacizumabDrug: Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks. Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks. | Drug | Arm A |
Primary outcome
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)
Time frame: approximately 2 years
Overall response rate (ORR)
Time frame: approximately to 2 years
4 secondary outcomes
Duration of response (DoR)
Time frame: approximately to 2 years
Disease control rate (DCR)
Time frame: approximately to 2 years
Progression-free survival (PFS)
Time frame: approximately to 2 years
Overall survival (OS)
Time frame: approximately to 5 years after last subject enrolled
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 8 Sep 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；Adebrelimab；SHR-8068；Bevacizumab in people with NSCLC, 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 7 inclusion and 11 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 8 Sep 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 Li Song (0518-82342973, li.song@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs) (time frame: approximately 2 years). The study lists 2 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 8 Sep 2026.