Non-Small Cell Lung CancerPhase 2NCT07489703

SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC

A Phase 2 study testing SHR-A1811 plus AK112 in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University.

Not yet recruiting

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

Trial summary

This is a phase II, open-label, single-arm study evaluating the efficacy and safety of SHR-A1811 (a HER2-targeted ADC) combined with AK112 (a PD-1/VEGF bispecific antibody) in patients with HER2-amplified or overexpressed locally advanced or metastatic NSCLC. 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 plus AK112
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 30 Apr 2026to 31 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

Signed ICF.
Age 18-75.
ECOG PS 0-1.
Life expectancy ≥3 months.
Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.
Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .

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≥1 measurable lesion per RECIST 1.1.
Adequate organ and bone marrow function.
Use of effective contraception.

Who cannot join

History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
Arterial/venous thrombotic event within 6 months.
Significant cardiovascular disease.
Active autoimmune disease requiring systemic treatment.
Use of systemic immunosuppressants within 2 weeks prior.
Symptomatic pleural/pericardial/ascitic effusion requiring drainage.
Symptomatic, progressive, or diffusely spread CNS metastases.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Li Zhang, Professor contact

+86-20-87343289

zhangli@sysucc.org.cn

Yan Huang, Professor contact

huangyan@sysucc.org.cn

About this study

Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities

Read the detailed description

The study consists of two cohorts: Cohort 1 includes patients who failed standard first-line therapy; Cohort 2 includes treatment-naïve patients. Patients will receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.

Conditions: Non-Small Cell Lung Cancer
Being tested: SHR-A1811 plus AK112
Keywords: NSCLC, HER2
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 plus AK112Drug
Patients will receive the combination of SHR-A1811 and AK112 until disease progression or until other predefined discontinuation criteria are met, whichever occurs first.

Study groups in NCT07489703
Study group	Role	What they receive
Cohort 1	Experimental	Cohort 1 includes patients who failed standard first-line therapy, patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first. Receives: Drug: SHR-A1811 plus AK112
Cohort 2	Experimental	Cohort 2 includes treatment-naïve patients. Patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first. Receives: Drug: SHR-A1811 plus AK112

What is being measured

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

PFS
Progression-free survival (PFS), defined as the time from first study treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.

Secondary outcomes (6)

DOR
Duration of response (DOR), defined as the time from the first documented objective response (complete response or partial response) to the first documented disease progression or death from any cause prior to progression, whichever occurs first. Objective response is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From the date of first documented objective response to the date of first documented disease progression or death from any cause prior to progression, whichever occurs first, assessed up to approximately 36 months.
ORR
Objective response rate (ORR), defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months.
OS
Overall survival (OS), defined as the time from first study treatment to death from any cause.
Measured: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months.
Adverse Events
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Relationship to study treatment (SHR-A1811 and/or AK112) is assessed by the investigator.
Measured: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
Serious Adverse Events
Incidence of serious adverse events (SAEs), regardless of causality, as defined in the study protocol. SAEs include events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, are congenital anomalies/birth defects, or are other medically important conditions.
Measured: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
Treatment-Related Adverse Events
Incidence and severity of treatment-related adverse events (TRAEs), defined as adverse events assessed by the investigator as having a reasonable possibility of causal relationship to SHR-A1811 and/or AK112. Severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From first dose of study treatment through 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first.

Timeline

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

30 Apr 202631 Dec 2028

First posted24 Mar 2026
Study start30 Apr 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 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 Sun Yat-sen UniversityThe 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: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07489703
Sponsor's protocol ID: MA-NSCLC-II-062
Status last verified: Mar 2026
First submitted: 18 Mar 2026
Last updated: 24 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD sharing was not included in the informed consent form approved by the ethics committee. Therefore, sharing individual participant data would violate the ethical agreements made with study participants.

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SHR-A1811 Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With HER2 Abnormalities
ClinicalTrials.gov ID: NCT07489703
Acronym / sponsor ID: MA-NSCLC-II-062
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC, HER2
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 30 Apr 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: SHR-A1811 plus AK112Cohort 1 includes patients who failed standard first-line therapy, patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.
Cohort 2	Experimental	Drug: SHR-A1811 plus AK112Cohort 2 includes treatment-naïve patients. Patients receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.

Who may qualify

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

Key inclusion criteria (9 listed)

Signed ICF.
Age 18-75.
ECOG PS 0-1.
Life expectancy ≥3 months.
Histologically/cytologically confirmed locally advanced or metastatic/recurrent NSCLC, not eligible for curative surgery or definitive chemoradiotherapy.

Key exclusion criteria (7 listed)

History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
Arterial/venous thrombotic event within 6 months.
Significant cardiovascular disease.
Active autoimmune disease requiring systemic treatment.
Use of systemic immunosuppressants within 2 weeks prior.

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 plus AK112Patients will receive the combination of SHR-A1811 and AK112 until disease progression or until other predefined discontinuation criteria are met, whichever occurs first.	Drug	Cohort 1, Cohort 2

Primary outcome

PFS
Time frame: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 months.
Progression-free survival (PFS), defined as the time from first study treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

6 secondary outcomes

DOR
Time frame: From the date of first documented objective response to the date of first documented disease progression or death from any cause prior to progression, whichever occurs first, assessed up to approximately 36 months.
ORR
Time frame: From first study treatment to disease progression or initiation of new anti-tumor therapy, assessed up to approximately 36 months.
OS
Time frame: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months.
Adverse Events
Time frame: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
Serious Adverse Events
Time frame: From signing of informed consent through 90 days after the last dose of study treatment or initiation of new anti-tumor therapy, whichever occurs first.
Treatment-Related Adverse Events
Time frame: From first dose of study treatment through 90 days after the last dose or initiation of new anti-tumor therapy, whichever occurs first.

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 24 Mar 2026.
Individual participant dataSharing planned: No. IPD sharing was not included in the informed consent form approved by the ethics committee. Therefore, sharing individual participant data would violate the ethical agreements made with study participants.

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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.

Li Zhang, Professor contact

+86-20-87343289

zhangli@sysucc.org.cn

Yan Huang, Professor contact

huangyan@sysucc.org.cn

Li Zhang, Professor principal investigator

Sun Yat-sen University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811 plus AK112 in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University.

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 9 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Zhang, Professor (+86-20-87343289, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of first study treatment to the date of first documented disease progression or date of death from any cause, whichever occurs first, assessed up to approximately 36 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 NCT07489703.

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 24 Mar 2026.