Non Small Cell Lung CancerPhase 3NCT07896005

A Study of SHR-A1811 Combined With Adebrelimab for the First-line HER2-overexpressing Non-squamous Non-small Cell Lung Cancer

A Phase 3 study testing SHR-A1811 Injection, Adebrelimab Injection and Tislelizumab Injection in people with Non Small Cell Lung Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a randomized, open-label, multicenter, phase 3 clinical study comparing the efficacy and safety of SHR-A1811 in combination with Adebrelimab versus platinum-based doublet chemotherapy in combination with Tislelizumab as first-line treatment in patients with HER2-overexpressing locally advanced or metastatic… 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-A1811 Injection, Adebrelimab Injection and Tislelizumab Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 436 participants
Where: 2 sitesChina
Study dates: Dec 2026to Mar 2032
Phase: Phase 3
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

Able to provide informed consent, willing and able to comply with the scheduled visits, examinations, and other procedural requirements of the treatment.
Aged 18-75 years (inclusive) at the time of signing the informed consent form, with no restriction on sex.
ECOG score of 0 or 1.
Patients with histologically confirmed locally advanced or metastatic non-squamous NSCLC.
Participants with HER2 overexpression confirmed by a central laboratory.
Have not previously received systemic antitumor therapy for locally advanced or metastatic NSCLC.

Who cannot join

Participants with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
Previous or current with other malignancies.
Prior antitumor toxicity and/or complications have not recovered to NCI-CTCAE ≤ Grade 1.
Currently participating in another clinical study, or the interval between the start of study treatment and the end of the previous clinical study is less than specified period.
Participants with active or previous autoimmune diseases.
Participants with uncontrolled or severe cardiovascular diseases.
Participants with active hepatitis B or hepatitis C.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liju Zong, M.M contact

86-518-81220121

liju.zong@hengrui.com

China2 sites

Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song, 86-517-88122088, songzb@zjcc.org.cn
Zhengbo Song
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu, 86-21-22200000 ext. 3403, shun_lu@hotmail.com
Shun Lu

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Conditions: Non Small Cell Lung Cancer
Being tested: SHR-A1811 Injection, Adebrelimab Injection, Tislelizumab Injection, Pemetrexed Disodium For Injection, Carboplatin injection
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-A1811 InjectionDrug
SHR-A1811 Injection.
Adebrelimab InjectionDrug
Adebrelimab Injection.
Tislelizumab InjectionDrug
Tislelizumab Injection.
Pemetrexed Disodium For InjectionDrug
Pemetrexed Disodium For Injection.
Carboplatin injectionDrug
Carboplatin Injection.
Cisplatin injectionDrug
Cisplatin Injection.

Study groups in NCT07896005
Study group	Role	What they receive
SHR-A1811 + Adebrelimab Group	Experimental	SHR-A1811, Adebrelimab Group. Receives: Drug: SHR-A1811 Injection; Drug: Adebrelimab Injection
Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)	Active comparator	Tislelizumab, Pemetrexed, Carboplatin/Cisplatin. Receives: Drug: Tislelizumab Injection; Drug: Pemetrexed Disodium For Injection; Drug: Carboplatin injection; Drug: Cisplatin injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS) based on blinded independent central review (BICR)
PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by BICR.
Measured: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
Measured: From randomization until death from any cause, up to approximately 50 months.
Progression-Free Survival (PFS) assessed by the Investigator
PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Investigator.
Measured: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Objective Response Rate (ORR) assessed by the Investigator and BICR
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), in accordance with RECIST v1.1, as assessed by the Investigator and BICR.
Measured: From randomization until confirmed objective response, up to approximately 40 months.
Duration of Response (DoR) assessed by the Investigator and BICR
DoR is defined, in accordance with RECIST v1.1, as the time from the date of the first documented CR or PR to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Investigator and BICR.
Measured: From the first documented objective response until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Disease Control Rate (DCR) assessed by the Investigator and BICR
DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD), in accordance with RECIST v1.1, as assessed by the Investigator and BICR.
Measured: From randomization until confirmed disease control, up to approximately 40 months.
Incidence and Severity of Adverse Events (AEs), graded according to NCI-CTCAE v6.0
This outcome is defined as the number and proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation of study treatment. AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
Measured: From the first dose of study treatment through 30 days after the last dose, up to approximately 40 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2026Mar 2032

First posted26 Oct 2026
Study startDec 2026 (estimated)
Primary completionFeb 2031 (estimated)
Study completionMar 2032 (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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible patients will be randomly assigned in a 1:1 ratio to one of the following two treatment arms: Experimental Arm: SHR-A1811 in combination with Adebrelimab; Active Comparator Arm: Platinum-based doublet chemotherapy in combination with Tislelizumab.
Masking: None (open label)
Enrolment: 436 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07896005
Sponsor's protocol ID: SHR-A1811-323
Status last verified: Oct 2026
First submitted: 19 Oct 2026
Last updated: 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Study of SHR-A1811 Combined With Adebrelimab for the First-line Treatment of Patients With HER2-overexpressing Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07896005
Acronym / sponsor ID: SHR-A1811-323
Conditions: Non Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 436 participants (estimated)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2026 (estimated)
Primary completion: Feb 2031 (estimated)
Study completion: Mar 2032 (estimated)
First posted: 26 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Eligible patients will be randomly assigned in a 1:1 ratio to one of the following two treatment arms: Experimental Arm: SHR-A1811 in combination with Adebrelimab; Active Comparator Arm: Platinum-based doublet chemotherapy in combination with Tislelizumab.

Arm	Type	Receives
SHR-A1811 + Adebrelimab Group	Experimental	Drug: SHR-A1811 Injection, Drug: Adebrelimab InjectionSHR-A1811, Adebrelimab Group.
Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)	Active comparator	Drug: Tislelizumab Injection, Drug: Pemetrexed Disodium For Injection, Drug: Carboplatin injection, Drug: Cisplatin injectionTislelizumab, Pemetrexed, Carboplatin/Cisplatin.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to provide informed consent, willing and able to comply with the scheduled visits, examinations, and other procedural requirements of the treatment.
Aged 18-75 years (inclusive) at the time of signing the informed consent form, with no restriction on sex.
ECOG score of 0 or 1.
Patients with histologically confirmed locally advanced or metastatic non-squamous NSCLC.
Participants with HER2 overexpression confirmed by a central laboratory.

Key exclusion criteria (7 listed)

Participants with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
Previous or current with other malignancies.
Prior antitumor toxicity and/or complications have not recovered to NCI-CTCAE ≤ Grade 1.
Currently participating in another clinical study, or the interval between the start of study treatment and the end of the previous clinical study is less than specified period.
Participants with active or previous autoimmune diseases.

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-A1811 InjectionSHR-A1811 Injection.	Drug	SHR-A1811 + Adebrelimab Group
Adebrelimab InjectionAdebrelimab Injection.	Drug	SHR-A1811 + Adebrelimab Group
Tislelizumab InjectionTislelizumab Injection.	Drug	Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)
Pemetrexed Disodium For InjectionPemetrexed Disodium For Injection.	Drug	Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)
Carboplatin injectionCarboplatin Injection.	Drug	Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)
Cisplatin injectionCisplatin Injection.	Drug	Standard of Care (Tislelizumab + Pemetrexed + Carboplatin/Cisplatin)

Primary outcome

Progression-free survival (PFS) based on blinded independent central review (BICR)
Time frame: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by BICR.

6 secondary outcomes

Overall Survival (OS)
Time frame: From randomization until death from any cause, up to approximately 50 months.
Progression-Free Survival (PFS) assessed by the Investigator
Time frame: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Objective Response Rate (ORR) assessed by the Investigator and BICR
Time frame: From randomization until confirmed objective response, up to approximately 40 months.
Duration of Response (DoR) assessed by the Investigator and BICR
Time frame: From the first documented objective response until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Disease Control Rate (DCR) assessed by the Investigator and BICR
Time frame: From randomization until confirmed disease control, up to approximately 40 months.
Incidence and Severity of Adverse Events (AEs), graded according to NCI-CTCAE v6.0
Time frame: From the first dose of study treatment through 30 days after the last dose, up to approximately 40 months.

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 26 Oct 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.

Liju Zong, M.M contact

86-518-81220121

liju.zong@hengrui.com

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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, M.M (86-518-81220121, liju.zong@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) based on blinded independent central review (BICR) (time frame: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07896005.

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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.