NSCLCPhase 2NCT07662473
The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression
A Phase 2 study testing Experimental Group in people with NSCLC, run by Hunan Province Tumor Hospital.
Trial summary
This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Experimental Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2026to 30 Jun 2028
- 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
- Male and female participants must be at least 18 years of age at the time of signing the ICF.
- Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and/or Stage IV NSCLC.
- Participants must have HER2 overexpression (IHC 3+).
- progressed following at least one or two prior systemic treatment.
- Prior anti-HER2 are eligible except for HER2 ADC.
- At least 1 measurable lesion by the investigator based on RECIST 1.1.
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- LVEF ≥ 50% within 28 days before enrollment.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
- Adequate organ and bone marrow function within 14 days before enrolment. All parameters must be the most recent results available.
- Adequate treatment washout period before enrolment.
- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
Who cannot join
- Has spinal cord compression or clinically active central nervous system metastases.
- Corrected QT interval (QTcF) prolongation to > 470 msec (females) or >450 msec (males) based on average of the screening triplicate12-lead ECG.
- History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection or active hepatitis B (hepatitis B virus surface antigen or hepatitis B virus core antibody positive, at screening) or C infection.
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan.
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- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.
- Known allergy or hypersensitivity to study treatment or any of the study drug excipients
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Pregnant or breastfeeding female participants, or participants who are planning to become pregnant.
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- Any other clinically significant medical conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.
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: The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm, Multicenter, Prospective Study
This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy
- Conditions
- NSCLC
- Being tested
- Experimental Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg as an IV infusion Q3W, on Day 1 of each 3-week cycle
| Study group | Role | What they receive |
|---|---|---|
| T-DXd group | Experimental | All participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg Receives: Drug: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of T-DXd by evaluation of Progression-free survival
Endpoints based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
- Progression-free survival (PFS)
Measured: UP to approximately 3 years
Secondary outcomes (4)
To assess the Overall survival (OS) of T-DXd
To assess the Overall survival (OS) of T-DXd
Measured: UP to approximately 3 years
To assess the Objective response rate (ORR) of T-DXd
To assess the Objective response rate (ORR) of T-DXd based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: UP to approximately 3 years
To assess the Disease control rate (DCR) of T-DXd
To assess the Disease control rate (DCR) of T-DXd
Measured: UP to approximately 3 years
Safety and toxicity
Adverse events/serious adverse events (AEs/SAEs)
Measured: 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 posted23 Jun 2026
- Study start29 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (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.
- 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
- Model description
- Provide details about the Interventional Study Model. A single arm, multicenter, prospective study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662473
- Sponsor's protocol ID
- ESR-25-22990
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm, Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT07662473
- Acronym / sponsor ID
- ESR-25-22990
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 29 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jun 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, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Provide details about the Interventional Study Model. A single arm, multicenter, prospective study
| Arm | Type | Receives |
|---|---|---|
| T-DXd group | Experimental | Drug: Experimental GroupAll participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female participants must be at least 18 years of age at the time of signing the ICF.
- Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and/or Stage IV NSCLC.
- Participants must have HER2 overexpression (IHC 3+).
- progressed following at least one or two prior systemic treatment.
- Prior anti-HER2 are eligible except for HER2 ADC.
Key exclusion criteria (12 listed)
- Has spinal cord compression or clinically active central nervous system metastases.
- Corrected QT interval (QTcF) prolongation to > 470 msec (females) or >450 msec (males) based on average of the screening triplicate12-lead ECG.
- History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection or active hepatitis B (hepatitis B virus surface antigen or hepatitis B virus core antibody positive, at screening) or C infection.
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 |
|---|---|---|
| Experimental GroupAll participants enrolled in the study will receive the study intervention (T-DXd) 5.4 mg/kg as an IV infusion Q3W, on Day 1 of each 3-week cycle | Drug | T-DXd group |
Primary outcome
To assess the efficacy of T-DXd by evaluation of Progression-free survival
Time frame: UP to approximately 3 years
Endpoints based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Progression-free survival (PFS)
4 secondary outcomes
To assess the Overall survival (OS) of T-DXd
Time frame: UP to approximately 3 years
To assess the Objective response rate (ORR) of T-DXd
Time frame: UP to approximately 3 years
To assess the Disease control rate (DCR) of T-DXd
Time frame: UP to approximately 3 years
Safety and toxicity
Time frame: 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 23 Jun 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 Experimental Group in people with NSCLC, run by Hunan Province Tumor 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 12 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 Jun 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 Chang Yong Zhang (+86 13873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of T-DXd by evaluation of Progression-free survival (time frame: UP to approximately 3 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 23 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.