Non-Small Cell Lung CancerNSCLCNCT07377916
Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC
A study testing SHR-A1811 in people with Non-Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- 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
- Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)
- Pathologically documented HER2 mutation, amplification, or overexpression
- Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease
- There is at least one measurable lesion according to RECIST V1.1 criteria
- ECOG score of 0 or 1.
- The expected survival is ≥12 weeks
Who cannot join
- There are untreated or active central nervous system (CNS) tumor metastases
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration
- Systemic antitumor therapy was performed 4 weeks prior to study initiation
- Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.
- Use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within less than 5 drug half-lives prior to the first dose.
- Has active infection requiring systemic treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer
The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.
Read the detailed description
Patients who meet the following criteria are enrolled:
Aged 18-75 years Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) Pathologically documented HER2 mutation, amplification, or overexpression Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease Received SHR-A1811 combined with pertuzumab
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SHR-A1811
- 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-A1811Drug
Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 combined with pertuzumab | Experimental | Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab Receives: Drug: SHR-A1811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) by investigator assessment
Measured: Until progression, assessed up to approximately 2 years
Secondary outcomes (5)
Objective Response Rate （ORR）
Measured: Two years after the last subject was enrolled in the group
Overall Survival (OS)
Measured: Until death, assessed up to approximately 3 years
Disease Control Rate (DCR)
Measured: Two years after the last subject was enrolled in the group
Duration of Response (DOR)
Measured: Two years after the last subject was enrolled in the group
AE
Measured: until to 90 days after the last dose，assessed up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (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 The First Affiliated Hospital of Guangzhou Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Maoming People's Hospital, Peking University Shenzhen Hospital
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377916
- Sponsor's protocol ID
- ES-2025-235-02
- Acronym
- NSCLC
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07377916
- Acronym / sponsor ID
- NSCLC / ES-2025-235-02
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Maoming People's Hospital, Peking University Shenzhen Hospital
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jan 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.
The study enrolled patients with advanced or metastatic NSCLC harboring HER2 mutations, amplification, or overexpression who had progressed after ≥1 prior lines of anticancer therapy. After enrollment, participants received treatment with rezetamab plus pertuzumab until disease progression, intolerable toxicity, withdrawal of consent, or other conditions requiring treatment discontinuation.
Detailed description
Patients who meet the following criteria are enrolled:
Aged 18-75 years Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition) Pathologically documented HER2 mutation, amplification, or overexpression Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease Received SHR-A1811 combined with pertuzumab
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 combined with pertuzumab | Experimental | Drug: SHR-A1811Intravenous infusion，Q3 week, SHR-A1811 combined with pertuzumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75 years
- Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC 9th edition)
- Pathologically documented HER2 mutation, amplification, or overexpression
- Received ≥1 prior line of systemic anti-cancer therapy for advanced/metastatic disease
- There is at least one measurable lesion according to RECIST V1.1 criteria
Key exclusion criteria (7 listed)
- There are untreated or active central nervous system (CNS) tumor metastases
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Pleural, ascites, or pericardial effusion requiring intervention occurred within 14 days prior to initial administration
- Systemic antitumor therapy was performed 4 weeks prior to study initiation
- Subjects who have previously received HER2-targeted therapy (excluding pan-HER tyrosine kinase inhibitors) or antibody-drug conjugates with a topoisomerase I inhibitor payload.
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-A1811Intravenous infusion, q3 week, SHR-A1811 combined with pertuzumab | Drug | SHR-A1811 combined with pertuzumab |
Primary outcome
Progression Free Survival (PFS) by investigator assessment
Time frame: Until progression, assessed up to approximately 2 years
5 secondary outcomes
Objective Response Rate （ORR）
Time frame: Two years after the last subject was enrolled in the group
Overall Survival (OS)
Time frame: Until death, assessed up to approximately 3 years
Disease Control Rate (DCR)
Time frame: Two years after the last subject was enrolled in the group
Duration of Response (DOR)
Time frame: Two years after the last subject was enrolled in the group
AE
Time frame: until to 90 days after the last dose，assessed up to approximately 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 30 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing SHR-A1811 in people with Non-Small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical 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 7 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 30 Jan 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.
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 Wenhua Liang (13710249454, 550627660@qq.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) by investigator assessment (time frame: Until progression, assessed up to approximately 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 30 Jan 2026.