NSCLCPhase 2NCT07778745
A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC
A Phase 2 study testing Adebrelimab and Trastuzumab rezetecan in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Adebrelimab and Trastuzumab rezetecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 30 Aug 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
- Aged 18-75 years, male or female.
- Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.
- Confirmed HER2 alteration: HER2 mutation/amplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).
- No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.
- At least 1 measurable target lesion per RECIST v1.1.
- ECOG performance status 0 or 1.
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- Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion).
- FEV1 >1.0 L and FEV1% predicted >40% within past 3 months.
- Adequate organ function within 7 days before first dose (no blood product/G-CSF support within 14 days):
- Hematology: WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L
- Liver: AST/ALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN
- Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL/min
- Cardiac: LVEF ≥50% by echocardiogram
- Fertile male/female participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose.
- Voluntarily sign written informed consent, good compliance for follow-up.
Who cannot join
- Mixed small cell/large cell neuroendocrine/sarcomatoid NSCLC histology.
- Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2.
- Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).
- Prior thoracic radiotherapy.
- Major surgery within 28 days or minor invasive surgery within 7 days before first dose.
- HIV infection, active hepatitis B/C, organ transplant history, congenital/acquired immunodeficiency.
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- Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment.
- Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month.
- Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring.
- Active uncontrolled ≥2 grade infection within 2 weeks before enrollment.
- Active tuberculosis under treatment.
- Known hypersensitivity to any component of study drugs or other monoclonal antibodies/fusion proteins.
- Any condition judged by investigator to compromise participant safety or trial compliance.
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
This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.
- Conditions
- NSCLC
- Being tested
- Adebrelimab, Trastuzumab rezetecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
1200mg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; consolidation therapy after local treatment as physician discretion. Infusion duration 30-60 minutes.
Trastuzumab rezetecanDrug
3.2mg/kg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; fixed dose 408mg if body weight ≥85kg. First infusion over 90 mins, subsequent cycles 60 mins if well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy | Experimental | Not described Receives: Drug: Adebrelimab; Drug: Trastuzumab rezetecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants achieving Complete Response (CR) or Partial Response (PR) after 3-4 cycles induction therapy, assessed per RECIST v1.1 by investigators
Measured: End of Cycle 3/Cycle 4 induction (each cycle 21 days). Surgery-eligible patients assess tumor 6-8 weeks after Cycle3 last dose; others evaluate at Cycle4 end, ±7-day imaging window.
Secondary outcomes (5)
Surgical Conversion Rate
Percentage of subjects receiving R0 radical pulmonary resection after MDT re-evaluation post induction
Measured: Within 6 to 8 weeks after the last induction study drug infusion (42-56 days post final induction dose)
Major Pathological Response (MPR) Rate
Proportion of surgical patients with ≤10% viable tumor cells in resected primary tumor specimen (central blinded pathology review)
Measured: Within 4 weeks after curative lung resection (pathology report completion window)
Event-Free Survival (EFS)
Time from first study drug dose to disease progression, local recurrence, distant metastasis, or death from any cause
Measured: Up to 36 months after the first dose of study treatment (3-year full survival follow-up)
Overall Survival (OS)
OS defined as time from first dose to all-cause death; survival rate calculated at fixed time points
Measured: 12 months, 18 months, 24 months, and 36 months after the first dose of study treatment
Safety Profile (Treatment-Related Adverse Events)
Incidence and grade of all adverse events, ≥3 grade AEs, serious adverse events (SAE), immune-related AEs, interstitial lung disease graded per NCI CTCAE v6.0
Measured: From the date of signed informed consent through 30 days after the last study treatment infusion; long-term safety follow-up continues up to 36 months post first dose for delayed irAEs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 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 Tianjin Medical University Cancer Institute and 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
- 37 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778745
- Sponsor's protocol ID
- NSCLC-HER2-II-001
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC
- ClinicalTrials.gov ID
- NCT07778745
- Acronym / sponsor ID
- NSCLC-HER2-II-001
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 21 Aug 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.
This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy | Experimental | Drug: Adebrelimab, Drug: Trastuzumab rezetecan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18-75 years, male or female.
- Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.
- Confirmed HER2 alteration: HER2 mutation/amplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).
- No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.
- At least 1 measurable target lesion per RECIST v1.1.
Key exclusion criteria (13 listed)
- Mixed small cell/large cell neuroendocrine/sarcomatoid NSCLC histology.
- Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2.
- Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).
- Prior thoracic radiotherapy.
- Major surgery within 28 days or minor invasive surgery within 7 days before first dose.
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 |
|---|---|---|
| Adebrelimab1200mg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; consolidation therapy after local treatment as physician discretion. Infusion duration 30-60 minutes. | Drug | Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy |
| Trastuzumab rezetecan3.2mg/kg intravenous infusion on Day 1 of every 21-day cycle for 3-4 induction cycles; fixed dose 408mg if body weight ≥85kg. First infusion over 90 mins, subsequent cycles 60 mins if well tolerated. | Drug | Experimental: Adebrelimab + Trastuzumab rezetecan Induction Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: End of Cycle 3/Cycle 4 induction (each cycle 21 days). Surgery-eligible patients assess tumor 6-8 weeks after Cycle3 last dose; others evaluate at Cycle4 end, ±7-day imaging window.
Proportion of participants achieving Complete Response (CR) or Partial Response (PR) after 3-4 cycles induction therapy, assessed per RECIST v1.1 by investigators
5 secondary outcomes
Surgical Conversion Rate
Time frame: Within 6 to 8 weeks after the last induction study drug infusion (42-56 days post final induction dose)
Major Pathological Response (MPR) Rate
Time frame: Within 4 weeks after curative lung resection (pathology report completion window)
Event-Free Survival (EFS)
Time frame: Up to 36 months after the first dose of study treatment (3-year full survival follow-up)
Overall Survival (OS)
Time frame: 12 months, 18 months, 24 months, and 36 months after the first dose of study treatment
Safety Profile (Treatment-Related Adverse Events)
Time frame: From the date of signed informed consent through 30 days after the last study treatment infusion; long-term safety follow-up continues up to 36 months post first dose for delayed irAEs.
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 Aug 2026.
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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 Adebrelimab and Trastuzumab rezetecan in people with NSCLC, run by Tianjin Medical University Cancer Institute and 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 15 inclusion and 13 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 21 Aug 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 Meng Wang Meng Wang (18622221623, 18622221623@pm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: End of Cycle 3/Cycle 4 induction (each cycle 21 days). Surgery-eligible patients assess tumor 6-8 weeks after Cycle3 last dose; others evaluate at Cycle4 end, ±7-day imaging window.). 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 Aug 2026.