Advanced Non-small Cell Lung CancerPhase 1/2NCT05482568
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2022to Dec 2026
- Phase
- Phase 1/2
- 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
- Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
- When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
- The ECOG score is 0 or 1
- The expected survival is ≥12 weeks
- Subjects with advanced or metastatic non-small cell lung cancer
- Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
Show all 11Show fewer
- Subjects who have failed prior standard care or are intolerant to standard care
- There is at least one measurable lesion
- Vital organs are functioning well
- Heart function is good
- Agree to birth control
Who cannot join
- There are untreated or active central nervous system (CNS) tumor metastases
- Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
- Systemic antitumor therapy was performed 4 weeks prior to study initiation
- Prior treatment with antibody-conjugated drugs
- Received >30 Gy chest radiation within 6 months prior to initial administration
- Palliative radiotherapy was completed within 7 days prior to initial administration
Show all 26Show fewer
- Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
- The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected
- Received systemic immunosuppressant therapy within 14 days prior to the first study
- Subjects with known or suspected interstitial pneumonia
- In the first study, failure to swallow, chronic diarrhea, gastroenteritis, intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis, or other medical conditions or special conditions affecting drug administration and absorption occurred within 28 days prior to administration
- Presence of any active, known or suspected autoimmune disease
- Have poorly controlled or severe cardiovascular disease
- Previous or concurrent malignancy
- Subjects who developed a severe infection within 28 days prior to the first dose
- Active hepatitis B
- There were active tuberculosis patients within 1 year before enrollment
- There is a history of immunodeficiency
- Live attenuated vaccine was administered within 28 days prior to initial study administration or is expected to be administered during study treatment
- Subjects who are participating in another clinical study or who have had their first dose less than 4 weeks since the end of the previous clinical study (last dose) or 5 half-lives of the study drug, whichever is shorter
- Major surgery other than diagnosis or biopsy was performed within 28 days prior to initial administration
- People who are known to be allergic to sir-A1811, pyrrolitinib, or any of the components of SIR-1316
- History of severe allergic reactions to other monoclonal antibody/fusion protein drugs
- Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study
- Uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse and detention
- Any other conditions that, in the investigator's judgment, may increase the risk of study participation, interfere with study results, or make study participation unsuitable
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhengbo Song
- Recruiting
Shanghai Chest hospital
Shanghai, Shanghai Municipality, 200030
Shun Lu
About this study
Official title: Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316Drug
Drug: SHR-A1811 \& Pyrotinib
SHR-A1811： intravenous Pyrotinib：oral
Drug: SHR-A1811 \& SHR-1316
SHR-A1811： intravenous SHR-1316： intravenous
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316 | Experimental | Not described Receives: Drug: SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT(Phase I (dose exploration phase) main study endpoint)
Measured: 21 days after the first administration of each subject
AE(Phase I (dose exploration phase) main study endpoint)
Measured: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Measured: Two years after the last subject was enrolled in the group
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Measured: Two years after the last subject was enrolled in the group
Secondary outcomes (25)
Toxin binding antibody to shr-a1811（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Objective Response Rate（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Duration of response（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
Progression Free Survival（Phase I secondary endpoint）
Measured: Two years after the last subject was enrolled in the group
AE（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Toxin binding antibody to shr-a1811（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Duration of response（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Progression Free Survival（Phase II secondary study endpoint）
Measured: Two years after the last subject was enrolled in the group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Sep 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open, multicenter, dose-increasing/investigational Phase IB/II clinical trial
- Masking
- None (open label)
- Enrolment
- 324 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
- NCT05482568
- Sponsor's protocol ID
- SHR-A1811-II-203
- Status last verified
- Apr 2026
- First submitted
- 26 Jul 2022
- Last updated
- 20 Apr 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2
- ClinicalTrials.gov ID
- NCT05482568
- Acronym / sponsor ID
- SHR-A1811-II-203
- Conditions
- Advanced Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Aug 2022 (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 was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open, multicenter, dose-increasing/investigational Phase IB/II clinical trial
| Arm | Type | Receives |
|---|---|---|
| SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316 | Experimental | Drug: SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
- When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
- The ECOG score is 0 or 1
- The expected survival is ≥12 weeks
- Subjects with advanced or metastatic non-small cell lung cancer
Key exclusion criteria (26 listed)
- There are untreated or active central nervous system (CNS) tumor metastases
- Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
- Systemic antitumor therapy was performed 4 weeks prior to study initiation
- Prior treatment with antibody-conjugated drugs
- Received >30 Gy chest radiation within 6 months prior to initial administration
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 & Pyrotinib/SHR-A1811 & SHR-1316Drug: SHR-A1811 \& Pyrotinib SHR-A1811： intravenous Pyrotinib：oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811： intravenous SHR-1316： intravenous | Drug | SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316 |
Primary outcome
DLT(Phase I (dose exploration phase) main study endpoint)
Time frame: 21 days after the first administration of each subject
AE(Phase I (dose exploration phase) main study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Time frame: Two years after the last subject was enrolled in the group
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Time frame: Two years after the last subject was enrolled in the group
25 secondary outcomes
Toxin binding antibody to shr-a1811（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Objective Response Rate（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Duration of response（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
Progression Free Survival（Phase I secondary endpoint）
Time frame: Two years after the last subject was enrolled in the group
AE（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Toxin binding antibody to shr-a1811（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Total antibody to shr-a1811（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of free toxin shr169265（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of pyrroltinib（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Plasma concentration of SHR-1316（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Anti shr-a1811 antibody positive（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-a1811（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Anti shr-1316 antibody positive（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
The positive status of neutralizing antibody against shr-1316（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Duration of response（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
Progression Free Survival（Phase II secondary study endpoint）
Time frame: Two years after the last subject was enrolled in the group
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 20 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316 in people with Advanced Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 11 inclusion and 26 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 20 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Suqiang Yu (+0518-82342973, suqiang.yu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT(Phase I (dose exploration phase) main study endpoint) (time frame: 21 days after the first administration of each subject). The study lists 4 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 20 Apr 2026.