NSCLCPhase 2NCT07281209
A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer
A Phase 2 study testing SHR-A1811 + Adebrelimab in people with NSCLC, run by Shanghai Chest Hospital.
Trial summary
This is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SHR-A1811 + Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2029
- 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
- Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
- Aged 18-75 years, male or female;
- Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC
- HER2 alterations identified by histological specimens;
- Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);
- ECOG score 0-1;
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- No contraindications to immunotherapy;
- Adequate organ function:
- Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
- Pulmonary function being able to withstand the planned surgery evaluated by surgeons;
- Women of childbearing potential must undergo a serum pregnancy test within 1 week prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug
Who cannot join
- Known EGFR sensitizing mutations or ALK fusions.
- Malignant pleural effusion. Drainable effusions during screening require thoracentesis to rule out malignancy.
- Prior anticancer therapy (radiotherapy, chemotherapy, immunotherapy), except curatively treated NSCLC with ≥5 years recurrence-free. Anticancer Chinese herbal medicine is allowed if stopped ≥2 weeks prior.
- Active or history of autoimmune diseases (e.g., uveitis, hepatitis, vasculitis, thyroiditis). Exceptions include: resolved childhood asthma, vitiligo, psoriasis, or alopecia without systemic treatment. Patients requiring bronchodilators are excluded.
- Immunodeficiency (e.g., HIV), active Hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL), or active Hepatitis C (HCV Ab+ \& detectable HCV RNA). Resolved HBV infection (anti-HBc+, HBsAg-) is allowed.
- Uncontrolled third-space fluid accumulation requiring repeated drainage.
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- Significant proteinuria (urine protein ≥++ and 24-hour protein ≥1.0 g) or severe hepatic/renal impairment.
- Systemic corticosteroids (>10 mg/day prednisone equivalent) or immunosuppressants within 14 days prior to first dose. Inhaled/topical steroids or physiologic replacement doses are permitted.
- Antitumor vaccines or immunostimulatory agents within 1 month prior to first dose.
- Systemic immunosuppressive therapy within 2 weeks prior to first dose or anticipated need during the study. Short-term, low-dose use may be permitted after Medical Monitor approval.
- Concurrent participation in another interventional clinical trial or prior interventional drug within 4 weeks (or 5 half-lives). Non-interventional study participation is allowed.
- Known or suspected interstitial lung disease, or other significant pulmonary conditions that may interfere with drug-related pulmonary toxicity evaluation.
- Severe cardiovascular disease, including: clinically significant arrhythmias; QTc ≥450 ms (male) or ≥470 ms (female); NYHA Class ≥III heart failure; or LVEF <50%.
- Severe infection within 4 weeks prior to first dose, or active infection requiring therapeutic antibiotics within 2 weeks prior (prophylactic antibiotics allowed).
- Active tuberculosis within 1 year prior to first dose.
- Major surgery within 28 days prior to first dose.
- History of allogeneic organ or stem cell transplantation.
- Pregnancy, lactation, or unwillingness to use effective contraception.
- Known allergy or hypersensitivity to SHR-A1811/Adebelimumab or their excipients.
- History of psychoactive drug abuse, alcohol abuse, or drug addiction. 21 Any other condition that may compromise patient safety or study compliance, per investigator's judgment.
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 Single-Arm Phase II Clinical Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer
This is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations.
- Conditions
- NSCLC
- Being tested
- SHR-A1811 + Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811 + AdebrelimabDrug
This study evaluates a novel, chemotherapy-free neoadjuvant regimen uniquely combining the HER2-targeting ADC SHR-A1811 with the anti-PD-L1 antibody Adebrelimab. This specific combination of a HER2-ADC and an immune checkpoint inhibitor in the pre-operative setting for HER2-altered NSCLC is the primary feature distinguishing this intervention.
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 combined with Adebelimumab | Experimental | Not described Receives: Drug: SHR-A1811 + Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathological Complete Response (pCR) Rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: up to 7 weeks after neoadjuvant
Secondary outcomes (5)
MPR rate
Major Pathological Response (MPR) Rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Measured: up to 7 weeks after neoadjuvant
ORR
Objective Response Rate (ORR) is defined as the percentage of participants achieving complete response (CR) and partial response (PR) for tumor volume reduction and maintaining the minimum duration requirement based on RECIST v1.1
Measured: up to 7 weeks after neoadjuvant
EFS
Event Free Survival (EFS) is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Measured: up to 3 years
OS
Overall survival (OS) is defined as the time from randomization until death from any cause.
Measured: up to 3 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: 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziming Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281209
- Sponsor's protocol ID
- IS25205
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Clinical Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07281209
- Acronym / sponsor ID
- IS25205
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Dec 2025 (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 is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations.
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 Adebelimumab | Experimental | Drug: SHR-A1811 + Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
- Aged 18-75 years, male or female;
- Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC
- HER2 alterations identified by histological specimens;
- Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);
Key exclusion criteria (20 listed)
- Known EGFR sensitizing mutations or ALK fusions.
- Malignant pleural effusion. Drainable effusions during screening require thoracentesis to rule out malignancy.
- Prior anticancer therapy (radiotherapy, chemotherapy, immunotherapy), except curatively treated NSCLC with ≥5 years recurrence-free. Anticancer Chinese herbal medicine is allowed if stopped ≥2 weeks prior.
- Active or history of autoimmune diseases (e.g., uveitis, hepatitis, vasculitis, thyroiditis). Exceptions include: resolved childhood asthma, vitiligo, psoriasis, or alopecia without systemic treatment. Patients requiring bronchodilators are excluded.
- Immunodeficiency (e.g., HIV), active Hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL), or active Hepatitis C (HCV Ab+ \& detectable HCV RNA). Resolved HBV infection (anti-HBc+, HBsAg-) is allowed.
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 + AdebrelimabThis study evaluates a novel, chemotherapy-free neoadjuvant regimen uniquely combining the HER2-targeting ADC SHR-A1811 with the anti-PD-L1 antibody Adebrelimab. This specific combination of a HER2-ADC and an immune checkpoint inhibitor in the pre-operative setting for HER2-altered NSCLC is the primary feature distinguishing this intervention. | Drug | SHR-A1811 combined with Adebelimumab |
Primary outcome
pCR rate
Time frame: up to 7 weeks after neoadjuvant
Pathological Complete Response (pCR) Rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
5 secondary outcomes
MPR rate
Time frame: up to 7 weeks after neoadjuvant
ORR
Time frame: up to 7 weeks after neoadjuvant
EFS
Time frame: up to 3 years
OS
Time frame: up to 3 years
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: 90 days after the last administration
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 15 Dec 2025.
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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 Phase 2 study testing SHR-A1811 + Adebrelimab in people with NSCLC, run by Shanghai Chest Hospital.
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 20 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 15 Dec 2025. 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 Zi ming Li (18017321562, liziming1980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: up to 7 weeks after neoadjuvant). 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 15 Dec 2025.