Non-Small Cell Lung Cancer With HER2- MutationsPhase 3NCT06430437
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
A Phase 3 study testing SHR-A1811 and PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin in people with Non-Small Cell Lung Cancer With HER2- Mutations, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer With HER2- Mutations
- What is being tested?
- SHR-A1811 and PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
- 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
- 29 Jul 2024to Apr 2027
- 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 and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- Subjects with central laboratory- confirmed functional HER2 mutations
- No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
- Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
Who cannot join
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
- Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
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- Subjects with active or previous autoimmune diseases.
- Subjects with uncontrolled or severe cardiovascular diseases.
- Subjects with active hepatitis B or hepatitis C.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu
About this study
Official title: A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
- Being tested
- SHR-A1811, PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ CisplatinDrug
Drug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W)
Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
| Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin） | Active comparator | Not described Receives: Drug: PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin |
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)
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
Measured: Until progression, assessed up to approximately 2 years
Secondary outcomes (3)
Overall Survival (OS)
Defined as time from randomization until the date of death due to any cause
Measured: Until death, assessed up to approximately 3 years
Progression Free Survival (PFS) by investigator assessment
Defined as time from randomization until progression per RECIST 1.1 as assessed by the investigator
Measured: Until progression, assessed up to approximately 2 years
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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 posted28 May 2024
- Study start29 Jul 2024
- Primary completionFeb 2026 (estimated)
- Study completionApr 2027 (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 Cancer With HER2- MutationsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430437
- Sponsor's protocol ID
- SHR-A1811-310
- Status last verified
- Feb 2025
- First submitted
- 21 May 2024
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06430437
- Acronym / sponsor ID
- SHR-A1811-310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 May 2024 (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 is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 | Experimental | Drug: SHR-A1811 |
| Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin） | Active comparator | Drug: PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- Subjects with central laboratory- confirmed functional HER2 mutations
Key exclusion criteria (9 listed)
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
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-A1811Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W) | Drug | SHR-A1811 |
| PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ CisplatinDrug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) | Drug | Standard of Care（PD-1/ PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin） |
Primary outcome
Progression-free survival (PFS) based on blinded independent central review (BICR)
Time frame: Until progression, assessed up to approximately 2 years
Defined as time from randomization until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)
3 secondary outcomes
Overall Survival (OS)
Time frame: Until death, assessed up to approximately 3 years
Progression Free Survival (PFS) by investigator assessment
Time frame: Until progression, assessed up to approximately 2 years
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
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 21 Jan 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 3 study testing SHR-A1811 and PD-1/PD-L1 inhibitors、Pemetrexed/ Paclitaxel、Carboplatin/ Cisplatin in people with Non-Small Cell Lung Cancer With HER2- Mutations, run by Jiangsu HengRui Medicine 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 9 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 21 Jan 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 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 You Li (0518-81220121, you.li.yl1@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: 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 21 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.