Non-Small Cell Lung CancerPhase 2NCT07836543
Trastuzumab Rezetecan and Adebrelimab, Alone or in Combination, After Chemoradiotherapy for HER2-Altered Unresectable Stage III Lung Cancer
A Phase 2 study testing Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab, Trastuzumab Rezetecan (SHR-A1811) and Adebrelimab in people with Non-Small Cell Lung Cancer, run by Ming Chen.
Trial summary
A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab, Trastuzumab Rezetecan (SHR-A1811) and Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- ECOG performance status 0-1.
- Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC).
- Radiologically confirmed unresectable Stage III NSCLC per AJCC 9th edition.
- Pathologically confirmed HER2 mutation or HER2 overexpression (IHC 2+ or 3+).
- Life expectancy ≥3 months.
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- Completed at least two cycles of platinum-based chemotherapy (concurrent or sequential) with definitive radiotherapy. Consolidation chemotherapy after radiotherapy is not permitted; chemotherapy with or without immunotherapy before concurrent chemoradiotherapy is permitted.
- Total radiotherapy dose 60 Gy ± 10% (54-66 Gy) using IMRT (preferred) or 3D-CRT, with acceptable dosimetric constraints.
- Adequate organ and bone marrow function.
- Negative pregnancy test for women of childbearing potential within 7 days prior to first dose. Willing to use effective contraception during the study and for 180 days after the last dose.
- Signed informed consent form (ICF).
Who cannot join
- Known EGFR-activating mutations or ALK fusions.
- Presence of other driver gene mutations with approved targeted therapies available.
- Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
- Prior treatment with HER2-targeted ADCs or HER2 TKIs.
- Malignant pleural effusion, pericardial effusion, or ascites.
- Participation in another clinical trial within 4 weeks or 5 half-lives prior to first dose.
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- Systemic immunosuppressive therapy within 2 weeks prior to first dose.
- Known HIV infection.
- Active hepatitis B (HBsAg positive with detectable HBV-DNA and ALT > ULN) or active hepatitis C.
- Active autoimmune disease requiring systemic treatment.
- Other malignancies within 5 years, except adequately treated cervical carcinoma in situ, basal/squamous cell skin carcinoma, localized prostate cancer, or ductal carcinoma in situ.
- Active or history of Grade ≥2 radiation pneumonitis per RTOG/EORTC, or symptomatic interstitial lung disease. Participants with grade 2 radiation pneumonitis that resolves to grade 1 or lower within 14 days without systemic glucocorticoid treatment may undergo screening if the investigator considers there to be no risk of recurrence.
- Significant cardiovascular disease.
- Severe infection within 4 weeks prior to first dose.
- Prior or planned allogeneic bone marrow or solid organ transplantation.
- Live attenuated vaccine within 28 days prior to first dose or planned during study. Pregnancy or breastfeeding.
- Known hypersensitivity to Adebrelimab, Trastuzumab Rezetecan, or any excipients.
- Known history of psychotropic substance abuse, alcohol abuse, or illicit drug use.
- Any condition that might impair the subject's ability to comply with study requirements.
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 Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy
A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC.
Read the detailed description
This is a randomized, open-label, multi-center phase II study evaluating the efficacy and safety of consolidation therapy with Trastuzumab Rezetecan combined with Adebrelimab versus Trastuzumab Rezetecan monotherapy versus Adebrelimab monotherapy in patients with unresectable stage III NSCLC harboring HER2 alterations (mutation or overexpression) who have not progressed after definitive concurrent or sequential chemoradiotherapy. Eligible patients will be randomized in a 1:1:1 ratio to receive either combination therapy, SHR-A1811 alone, or Adebrelimab alone for up to 12 months. The primary endpoint is progression-free survival (PFS) per RECIST v1.1.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab, Trastuzumab Rezetecan (SHR-A1811), Adebrelimab
- 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.
Trastuzumab Rezetecan (SHR-A1811) + AdebrelimabDrug
Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W) and Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.
Trastuzumab Rezetecan (SHR-A1811)Drug
Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.
AdebrelimabDrug
Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Combination Therapy) | Experimental | Drug: Trastuzumab Rezetecan + Adebrelimab Receives: Drug: Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab |
| Arm B (Targeted Monotherapy) | Experimental | Drug: Trastuzumab Rezetecan Receives: Drug: Trastuzumab Rezetecan (SHR-A1811) |
| Arm C (Immunotherapy Monotherapy) | Experimental | Drug: Adebrelimab Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Measured: Assessed up to approximately 36 months.
Secondary outcomes (10)
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Measured: Assessed up to approximately 60 months.
Objective Response Rate (ORR)
Defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR), as assessed according to RECIST v1.1.
Measured: Assessed up to approximately 36 months.
Duration of Response (DoR)
Defined as the time from the first documented response (CR or PR) to the first documented disease progression (PD) or death from any cause, whichever occurs first.
Measured: Assessed up to approximately 36 months.
Disease Control Rate (DCR)
Defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) following treatment, as assessed according to RECIST v1.1.
Measured: Assessed up to approximately 36 months.
Time to Death or Distant Metastasis (TTDM)
Defined as the time from randomization to the first occurrence of distant metastasis or death from any cause.
Measured: Assessed up to approximately 36 months.
Progression-Free Survival Rate at 6 Months
Kaplan-Meier estimate of the percentage of participants alive without disease progression at 6 months after randomization.
Measured: 6 months after randomization.
Progression-Free Survival Rate at 12 Months
Kaplan-Meier estimate of the percentage of participants alive without disease progression at 12 months after randomization.
Measured: 12 months after randomization.
Overall Survival Rate at 12 Months
Kaplan-Meier estimate of the percentage of participants alive at 12 months after randomization.
Measured: 12 months after randomization.
Overall Survival Rate at 24 Months
Kaplan-Meier estimate of the percentage of participants alive at 24 months after randomization.
Measured: 24 months after randomization.
Incidence of Adverse Events (AEs)
AEs graded by CTCAE version 6.0
Measured: Assessed up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1:1 ratio to three parallel arms: Arm A (Trastuzumab Rezetecan + Adebrelimab), Arm B (Trastuzumab Rezetecan monotherapy), and Arm C (Adebrelimab monotherapy).
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836543
- Sponsor's protocol ID
- MA-NSCLC-II-064
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter, Phase II Study of Trastuzumab Rezetecan With Adebrelimab, Trastuzumab Rezetecan Alone and Adebrelimab Alone as Consolidation Therapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring HER2 Alterations Without Progression After Definitive Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT07836543
- Acronym / sponsor ID
- MA-NSCLC-II-064
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ming ChenUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 23 Sep 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.
A randomized phase II study to assess the efficacy and safety of Trastuzumab Rezetecan and/or Adebrelimab as consolidation therapy following chemoradiotherapy in patients with unresectable stage III HER2-altered NSCLC.
Detailed description
This is a randomized, open-label, multi-center phase II study evaluating the efficacy and safety of consolidation therapy with Trastuzumab Rezetecan combined with Adebrelimab versus Trastuzumab Rezetecan monotherapy versus Adebrelimab monotherapy in patients with unresectable stage III NSCLC harboring HER2 alterations (mutation or overexpression) who have not progressed after definitive concurrent or sequential chemoradiotherapy. Eligible patients will be randomized in a 1:1:1 ratio to receive either combination therapy, SHR-A1811 alone, or Adebrelimab alone for up to 12 months. The primary endpoint is progression-free survival (PFS) per RECIST v1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomized in a 1:1:1 ratio to three parallel arms: Arm A (Trastuzumab Rezetecan + Adebrelimab), Arm B (Trastuzumab Rezetecan monotherapy), and Arm C (Adebrelimab monotherapy).
| Arm | Type | Receives |
|---|---|---|
| Arm A (Combination Therapy) | Experimental | Drug: Trastuzumab Rezetecan (SHR-A1811) + AdebrelimabDrug: Trastuzumab Rezetecan + Adebrelimab |
| Arm B (Targeted Monotherapy) | Experimental | Drug: Trastuzumab Rezetecan (SHR-A1811)Drug: Trastuzumab Rezetecan |
| Arm C (Immunotherapy Monotherapy) | Experimental | Drug: AdebrelimabDrug: Adebrelimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years.
- ECOG performance status 0-1.
- Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC).
- Radiologically confirmed unresectable Stage III NSCLC per AJCC 9th edition.
- Pathologically confirmed HER2 mutation or HER2 overexpression (IHC 2+ or 3+).
Key exclusion criteria (19 listed)
- Known EGFR-activating mutations or ALK fusions.
- Presence of other driver gene mutations with approved targeted therapies available.
- Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.
- Prior treatment with HER2-targeted ADCs or HER2 TKIs.
- Malignant pleural effusion, pericardial effusion, or ascites.
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 |
|---|---|---|
| Trastuzumab Rezetecan (SHR-A1811) + AdebrelimabTrastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W) and Adebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met. | Drug | Arm A (Combination Therapy) |
| Trastuzumab Rezetecan (SHR-A1811)Trastuzumab Rezetecan (4.8mg/kg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met. | Drug | Arm B (Targeted Monotherapy) |
| AdebrelimabAdebrelimab (1200mg, iv, d1, Q3W). Treatment will continue for up to 12 months or until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation are met. | Drug | Arm C (Immunotherapy Monotherapy) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Assessed up to approximately 36 months.
Defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
10 secondary outcomes
Overall Survival (OS)
Time frame: Assessed up to approximately 60 months.
Objective Response Rate (ORR)
Time frame: Assessed up to approximately 36 months.
Duration of Response (DoR)
Time frame: Assessed up to approximately 36 months.
Disease Control Rate (DCR)
Time frame: Assessed up to approximately 36 months.
Time to Death or Distant Metastasis (TTDM)
Time frame: Assessed up to approximately 36 months.
Progression-Free Survival Rate at 6 Months
Time frame: 6 months after randomization.
Progression-Free Survival Rate at 12 Months
Time frame: 12 months after randomization.
Overall Survival Rate at 12 Months
Time frame: 12 months after randomization.
Overall Survival Rate at 24 Months
Time frame: 24 months after randomization.
Incidence of Adverse Events (AEs)
Time frame: Assessed up to approximately 36 months.
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 23 Sep 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 Phase 2 study testing Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab, Trastuzumab Rezetecan (SHR-A1811) and Adebrelimab in people with Non-Small Cell Lung Cancer, run by Ming Chen.
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 19 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 23 Sep 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 Ming Chen, MD (+86 020-87345647, chenming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 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?
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 23 Sep 2026.