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Not yet recruitingNCT07781202Updated Aug 24, 2026

A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined With Radiotherapy in Patients With HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer

A Phase 2 interventional study of Trastuzumab Rezetecan combined with radiotherapy in HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies testing trastuzumab rezetecan in Carcinoma, Non-Small-Cell Lung — 10 open to participants now, 11 under way, 2 of them phase 3. trastuzumab rezetecan · Carcinoma, Non-Small-Cell Lung.

Planned enrollment
8th of 11
30 · median 60
Started
2026
with 7 others
Phase 2
6 of 11
6 open now
Primary completion
2029-08
later than 8 of 10 live
Registered
9th of 11
by date
Lead sponsor
1 of 11
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Among the 11 studies testing trastuzumab rezetecan in Carcinoma, Non-Small-Cell Lung, this one is the 8th largest by planned enrollment, is one of 8 that started in 2026, is one of 6 in phase 2, reaches primary completion later than 8 of the 10 other live ones, and was the 9th registered.

Carcinoma, Non-Small-Cell Lung

7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

10 of the 11 studies testing trastuzumab rezetecan in Carcinoma, Non-Small-Cell Lung are open now, in 1 country. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Where they have run

About trastuzumab rezetecan

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies testing trastuzumab rezetecan in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study summary

A Multicenter, Single-Arm, Prospective Phase II Clinical Study of Trastuzumab Rezetecan Combined with Radiotherapy in Patients with HER2-Mutated Oligoprogressive Advanced Non-Small Cell Lung Cancer

Read the detailed description

This is a multicenter, single-arm, prospective Phase II clinical study aiming to evaluate the efficacy and safety of Trastuzumab Rezetecan combined with radiotherapy in patients with HER2-mutated advanced non-small cell lung cancer with oligoprogression. A total of 30 subjects are planned to be enrolled. Eligible patients are those with HER2-mutated advanced non-small cell lung cancer who obtained clinical benefit following prior systemic therapy and subsequently developed oligoprogression.

Subjects meeting the eligibility criteria after screening will receive the following treatment: Trastuzumab Rezetecan administered intravenously at a dose of 4.8 mg/kg Q3W until disease progression or intolerable toxicity occurs.

Radiotherapy: Radiotherapy targeting oligoprogressive lesions is recommended to be completed within Cycle 1 or prior to Cycle 2 of Trastuzumab Rezetecan treatment. Radiotherapy shall adopt organ- and risk-adapted fractionation regimens with curative radiotherapy dose as the principle; high biological effective dose (BED) regimens capable of achieving durable local control are preferred. Stereotactic body radiation therapy (SBRT) may be prioritized for peripheral pulmonary, adrenal, hepatic and other lesions. Risk-adapted multifraction regimens will be applied to lesions located in the central thorax, mediastinal lymph nodes, spine and regions adjacent to critical organs at risk. The specific radiation dose will be determined comprehensively based on lesion location, size, distance to organs at risk and previous radiotherapy history.

03

Conditions studied

  • HER2-mutated Advanced Non-small Cell Lung Cancer With Oligoprogression

Keywords

  • HER2-mutated
  • oligoprogression
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged ≥18 and ≤75 years, male or female.
  2. Confirmed mutation (detected by PCR or NGS). Patients developed oligoprogression after achieving tumor response following prior systemic therapy for advanced NSCLC (CR/PR/SD lasting ≥6 months).

    Note: The number of is limited to ≤2 lines. Prior regimens may include platinum-based chemotherapy, chemoimmunotherapy, chemoimmunotherapy combined with anti-angiogenic therapy, HER2-TKIs, or Trastuzumab Rezetecan; however, patients must have received at least one line of platinum-based chemotherapy.

  3. Meet the definition of oligoprogression: under continuous systemic therapy, only 1-5 extracranial lesions progress, the number of organs involved by progressive lesions ≤3.
  4. All oligoprogressive lesions planned for radiotherapy are extracranial and amenable to safely delivered fractionated radiotherapy.
  5. (ECOG) performance status 0-1.
  6. Expected survival ≥3 months.
  7. At least one outside the planned radiation field at baseline per Version 1.1, to serve as target lesion for systemic efficacy evaluation.
  8. Pulmonary function: >70% of predicted value.
  9. Adequate function of major organs meeting the criteria below:

    • Hematology tests (no blood transfusion, granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulating factors administered within 14 days prior to the first study treatment):

    (Hb) ≥90 g/L; count (PLT) ≥100×10⁹/L; (ANC) ≥1.5×10⁹/L; White blood cell count (WBC) ≥3.0×10⁹/L.

    --Biochemistry tests: Liver function: (AST) and alanine aminotransferase (ALT) ≤3 × ; for patients with liver , ALT and AST ≤5 × ULN. Total serum (TBIL) ≤1.5 × ULN (for patients with confirmed Gilbert's syndrome, total bilirubin ≤3.0 mg/dL).

    Renal function: Serum creatinine ≤1.5 × ULN OR rate (CrCl) ≥50 mL/min (calculated using the Cockcroft-Gault formula). Urine protein \<2+ on dipstick. If urine protein ≥2+, additional 24-hour quantitative urine protein test is required; subjects with 24-hour urine protein \<1 g are eligible for enrollment.

    • Coagulation function: (APTT), international normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN.
    • Evaluated by Doppler echocardiography: (LVEF) ≥50%. basically normal; \<450 ms for males and \<470 ms for females.
  10. Non-surgically sterile women of and male subjects must agree to use at least one medically accepted method (e.g., intrauterine device, oral contraceptives, condoms) throughout study treatment and for 6 months after completion of study treatment. Non-surgically sterile women of childbearing potential must have a negative serum HCG test within 7 days before the first dose.
  11. Subjects voluntarily participate in this study, sign the form, demonstrate good compliance and are willing to complete follow-up visits.

Exclusion criteria

Exclusion Criteria:

1.Presence of EGFR sensitizing mutations (Exon 19 deletion / Exon 21 L858R), 2.ALK rearrangements, positive ROS1/RET fusions, MET exon 14 skipping mutations, or KRAS G12C mutations.

3.Uncontrolled or severe cardiovascular diseases, such as severe/unstable angina, symptomatic congestive heart failure ( Class II-IV), myocardial infarction within 6 months prior to the first study treatment, or unstable angina or unstable arrhythmia occurring within 1 month before initiation of study treatment.

4.Active central nervous system (CNS) tumor . Subjects with a history of or current leptomeningeal metastasis are excluded. Exception: Subjects with who have received adequate local therapy (surgery or radiotherapy) at least 2 weeks prior to the first dose, do not require therapy, have neurologically recovered to baseline (excluding residual signs/symptoms related to CNS treatment), and whose brain lesions are not oligoprogressive lesions in this study may be enrolled.

5.Presence of pleural effusion, ascites or pericardial effusion requiring intervention within 7 days before the first dose.

6.Receipt of extensive-field radiotherapy within the past 4 weeks, or anticipated overlap with the radiotherapy field in this study where organ risk constraints cannot be satisfied.

7.Toxicities and/or complications from prior interventions that have not recovered to Grade ≤1. Exception: Subjects may be enrolled if the investigator judges that adverse events are NCI-CTCAE Grade ≤2 and pose no safety risks. Subjects previously treated with with stable Type 1 diabetes or hypothyroidism under hormone replacement therapy are eligible.

8.Receipt of strong/moderate inhibitors or strong/moderate CYP3A4 inducers within the shorter of either 3 drug half-lives or 14 days prior to the first dose.

9.Subjects with known or suspected interstitial lung disease; moderate to severe pulmonary diseases that may interfere with detection or management of drug-related pulmonary toxicity and severely impair respiratory function within 3 months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, pulmonary embolism, severe asthma, severe , severe obstructive/restrictive ventilatory dysfunction; any , connective tissue or inflammatory diseases involving the lungs (e.g., rheumatoid arthritis, sicca syndrome, sarcoidosis), or history of prior pneumonectomy. Subjects who developed Grade ≥3 interstitial lung disease during previous immune checkpoint inhibitor treatment are excluded.

10.Other concurrent malignant tumors diagnosed within ≤3 years prior to the first dose, except for adequately treated papillary thyroid carcinoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally confined prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormonal therapy for non-metastatic prostate or breast cancer is permitted).

11.Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia; active infection of CTCAE Grade ≥2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose.

12.Active or infection. Subjects positive for HBsAg or HBc Ab may participate if HBV DNA is below the (ULN) of the local study laboratory; if no ULN is available at the site, HBV DNA must be \<1000 copies/mL or 500 IU/mL. Subjects positive for anti-HCV antibody may participate if HCV RNA is below the ULN of the local study laboratory.

13.History of active pulmonary tuberculosis infection within 1 year before enrollment confirmed by medical history or CT scan; or history of active pulmonary tuberculosis infection more than 1 year previously without standardized treatment.

14.History of immunodeficiency, including positive serology or history of organ transplantation.

15.Major surgery within 28 days prior to the first dose (excluding diagnostic surgery), or planned major surgery during the study period (excluding diagnostic surgery).

16.Administration of within 28 days before the first dose, or planned administration of live attenuated vaccines during the study.

17.Known history of severe allergic reaction to any component of trastuzumab rezetecan or radiotherapy.

18.Known psychiatric disorders, alcohol abuse, drug addiction or substance abuse.

19.Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.

20.Any other conditions that, in the investigator's judgment, may increase risks associated with study participation, interfere with study outcomes, or render the subject unsuitable for enrollment.

Terms in these criteria, in plain language(34)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental

    Trastuzumab Rezetecan combined with radiotherapy

    Drug: Trastuzumab Rezetecan combined with radiotherapy

Interventions

  • DrugTrastuzumab Rezetecan combined with radiotherapy

    Drug page: Trastuzumab rezetecan

    Trastuzumab Rezetecan administered intravenously at a dose of 4.8 mg/kg Q3W until disease progression or intolerable toxicity occurs. Radiotherapy: Radiotherapy targeting oligoprogressive lesions is recommended to be completed within Cycle 1 or prior to Cycle 2 of Trastuzumab Rezetecan treatment. Radiotherapy shall adopt organ- and risk-adapted fractionation regimens with curative radiotherapy dose as the principle; high biological effective dose (BED) regimens capable of achieving durable local control are preferred. Stereotactic body radiation therapy (SBRT) may be prioritized for peripheral pulmonary, adrenal, hepatic and other lesions. Risk-adapted multifraction regimens will be applied to lesions located in the central thorax, mediastinal lymph nodes, spine and regions adjacent to critical organs at risk. The specific radiation dose will be determined comprehensively based on lesion location, size, distance to organs at risk and previous radiotherapy history.

06

What researchers measure

Primary outcomes

  1. Safety (incidence of Grade ≥3 interstitial lung disease)

    from the first dose administration to the end of safety follow-up after study discontinuation

    Time frame: up to 12 months

Secondary outcomes

  1. Progression-free survival, PFS

    PFS is defined as the time elapsed between the start of treatment and the first sign of disease progression or death from any cause.

    Time frame: up to 12 months

  2. Overall response rate, ORR

    Defined as the proportion of patients whose tumor volume reduction meets the predefined threshold (CR/PR) and lasts for the minimum required duration according to recognized response evaluation criteria (e.g., RECIST Version 1.1 for solid tumors).

    Time frame: up to 12 months

  3. Disease control rate, DCR

    Number of cases with completed/partial response and stable disease after treatment as a percentage of evaluable cases.

    Time frame: up to 12 months

  4. duration of response, DoR

    Defined as the time interval from the first documented assessment of complete response (CR) or partial response (PR) to the first documented assessment of progressive disease (PD) or death due to any cause

    Time frame: up to 12 months

  5. Overall survival, OS

    OS is defined as the time elapsed between the initiation of treatment and mortality from any cause

    Time frame: up to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Khatri VM, Mestres-Villanueva MA, Yarlagadda S, Doniparthi A, Smith DB, Nakashima JY, Bryant JM, Zhao D, Upadhyay R, Mills MN, Oliver DE, Yu HM, Palmer JD, Williams NO, Mahtani RL, Ahluwalia MS, Soliman HH, Han HS, Soyano AE, Kim Y, Kotecha R, Beyer SJ, Ahmed KA. Multi-institutional report of trastuzumab deruxtecan and stereotactic radiosurgery for HER2 positive and HER2-low breast cancer brain metastases. NPJ Breast Cancer. 2024 Nov 21;10(1):100. doi: 10.1038/s41523-024-00711-w. PubMed 39572568 ↗
  • Dingemans AC, Hendriks LEL, Berghmans T, Levy A, Hasan B, Faivre-Finn C, Giaj-Levra M, Giaj-Levra N, Girard N, Greillier L, Lantuejoul S, Edwards J, O'Brien M, Reck M, Smit EF, Van Schil P, Postmus PE, Ramella S, Lievens Y, Gaga M, Peled N, Scagliotti GV, Senan S, Paz-Ares L, Guckenberger M, McDonald F, Ekman S, Cufer T, Gietema H, Infante M, Dziadziuszko R, Peters S, Porta RR, Vansteenkiste J, Dooms C, de Ruysscher D, Besse B, Novello S. Definition of Synchronous Oligometastatic Non-Small Cell Lung Cancer-A Consensus Report. J Thorac Oncol. 2019 Dec;14(12):2109-2119. doi: 10.1016/j.jtho.2019.07.025. Epub 2019 Aug 6. PubMed 31398540 ↗
  • Lebow ES, Pike LRG, Seidman AD, Moss N, Beal K, Yu Y. Symptomatic Necrosis With Antibody-Drug Conjugates and Concurrent Stereotactic Radiotherapy for Brain Metastases. JAMA Oncol. 2023 Dec 1;9(12):1729-1733. doi: 10.1001/jamaoncol.2023.4492. PubMed 37883079 ↗
  • Loap P, Chabli S, Cottu P, Kirova Y. Safety and Tolerability of Concurrent Radiotherapy and Sacituzumab Govitecan in Metastatic Breast Cancer. Am J Clin Oncol. 2025 Aug 1;48(8):399-402. doi: 10.1097/COC.0000000000001195. Epub 2025 Apr 3. PubMed 40178882 ↗
  • Debbi K, Benderra MA, Medioni J, Durdux C, To NH, Boukhobza C, Grellier N, Benmaziane A, Monnier L, Gligorov J, Assaf E, Belkacemi Y. Safety and efficacy of combined trastuzumab-deruxtecan and concurrent radiation therapy in breast cancer. The TENDANCE multicentric French study. Breast. 2025 Apr;80:104421. doi: 10.1016/j.breast.2025.104421. Epub 2025 Feb 13. PubMed 39983437 ↗
  • Stumpf PK, Cittelly DM, Robin TP, Carlson JA, Stuhr KA, Contreras-Zarate MJ, Lai S, Ormond DR, Rusthoven CG, Gaspar LE, Rabinovitch R, Kavanagh BD, Liu A, Diamond JR, Kabos P, Fisher CM. Combination of Trastuzumab Emtansine and Stereotactic Radiosurgery Results in High Rates of Clinically Significant Radionecrosis and Dysregulation of Aquaporin-4. Clin Cancer Res. 2019 Jul 1;25(13):3946-3953. doi: 10.1158/1078-0432.CCR-18-2851. Epub 2019 Apr 2. PubMed 30940654 ↗
  • Salvestrini V, Kim K, Caini S, Alkner S, Ekholm M, Skytta T, Becherini C, Coles CE, Kaidar-Person O, Offersen B, de Azambuja E, Visani L, Cortes J, Harbeck N, Rugo HS, Isacke CM, Marangoni E, Morandi A, Lambertini M, Poortmans P, Livi L, Meattini I. Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: A systematic review and meta-analysis. Radiother Oncol. 2023 Sep;186:109805. doi: 10.1016/j.radonc.2023.109805. Epub 2023 Jul 10. PubMed 37437610 ↗
  • Natangelo S, Trapani D, Koukoutzeli C, Boscolo Bielo L, Marvaso G, Jereczek-Fossa BA, Curigliano G. Radiation therapy, tissue radiosensitization, and potential synergism in the era of novel antibody-drug conjugates. Crit Rev Oncol Hematol. 2024 Mar;195:104270. doi: 10.1016/j.critrevonc.2024.104270. Epub 2024 Jan 24. PubMed 38272150 ↗
  • Li Z, Wang Y, Sun Y, Wang L, Li X, Sun L, He Z, Yang H, Wang Y, Wang Q, Song Z, Hong W, Wang Y, Xia G, Yu Y, Peng M, Song Y, Wang D, Meng R, Fang J, Luo Y, Liang W, Hu S, Wang Z, Song K, Li Y, Yang L, Shi W, Lu S. Trastuzumab rezetecan, a HER2-directed antibody-drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025 Apr;26(4):437-446. doi: 10.1016/S1470-2045(25)00012-9. Epub 2025 Feb 25. PubMed 40020696 ↗
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Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2029, 36 months later.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 36 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 24, 2026
StartEst.
Aug 30, 2026
Primary completionEst.
Aug 30, 2029
CompletionEst.
Aug 30, 2029
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781202
Responsible party
Xiaorong Dong (Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Aug 24, 2026
Start date
Aug 30, 2026 (estimated)
Primary completion
Aug 30, 2029 (estimated)
Completion
Aug 30, 2029 (estimated)
Last update
Aug 24, 2026

Study contacts

Xiao rong XR Dong
Contact
xiaorongdong@hust.edu.cn
13986252286

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Trastuzumab rezetecan

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