NETS Ga68 Lu177Phase 3NCT07057622
A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs
A Phase 3 study testing 177Lu-DOTATATE injection and Octreotide LAR (Long-acting release) in people with NETS Ga68 Lu177, run by HTA Co., Ltd. at 1 site in China.
Trial summary
The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NETS Ga68 Lu177
- What is being tested?
- 177Lu-DOTATATE injection and Octreotide LAR (Long-acting release)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2023to 24 Feb 2027
- Phase
- Phase 3
- 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
- Ability to understand and the willingness to sign a written informed consent document;
- Age ≥18 years ;
- Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;
- Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium [68Ga] dobutamine injection as somatostatin receptor positive(IRC confirmed);
- There is at least one measurable lesion at baseline;
- BaselineECOG score 0 or 1;
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- Adeguate organ and bone marrow function as defined below:
- bone marrow:Neutrophil count (ANC)≥1.5×109/L, platelet count ≥75×109/L,hemoglobin ≥80g/L,no blood transfusion or growth factor treatment within 14 days before randomization.(colony stimulating factor (CSF), colony stimulating factor (CSF),Erythropoietin(EPO),etc.); b) Liver function:aspartate aminotransferase(AST)and alanine aminotransferase(ALT)≤2.5 ULN; total bilirubin( TBIL ) ≤1.5 × ULN; c ) Renal function : serum creatinine ≤150μmol/ L or 1.7mg / dL, or creatinine clearance rate (CLcr)≥50mL/min calculated by Cockroft Gault method; d) Baseline left ventricular ejection fraction (LVEF)≥50 % measured by multi-gate circuit controlled acquisition(MUGA) or echocardiography(ECHO); e ) Coagulation function: international normalized ratio(INR)≤1.5 ×ULN,activated partial thromboplastin time(APTT ) ≤1.5 × ULN ; f) Serum albumin \> 3.0g/ dL.
- Subjects with childbearing potential voluntarily use effective contraceptive methods,such as condoms, oral or injectable contraceptives, intrauterine devices, etc, during treatment and within 4 months (men) or 7months(women)after the last use of the investigational drug.
Who cannot join
- Human immunodeficiency virus (HIV) antibody positive;
- Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));
- Pregnant or lactating women;
- Received peptide receptor radionuclide therapy (PRRT) before randomization;
- Received Octreotide LAR treatment with a dose intensity \>30 mg/3-4 weeks (increased dose or frequency) within 12 weeks before randomization;
- Subjects who are receiving short-acting octreotide treatment cannot stop short-acting octreotide within 24 hours before and 24 hours after administration of 177Lu-DOTATATE or subjects who are receiving Octreotide LAR treatment cannot stop Octreotide LAR within 4 weeks before administration of 177Lu-DOTATATE;
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- Have received systemic anti-tumor treatments such as targeted therapy, immunotherapy,anti-tumor Chinese medicine treatment, chemotherapy,etc.within 4 weeks before randomization;
- Participated in other drug clinical trials and received corresponding experimental drugs within 4 weeks before randomization, except for the PET/CT study of the diagnostic drug68Ga-DOTATATE injection initiated by the sponsor of this trial;
- Received the following treatments within 12 weeks before randomization,including but not limited to surgery (except biopsy),radical radiotherapy,hepatic artery interventional embolization,cryoablation or radiofrequency ablation of liver metastases;
- Received palliative radiotherapy for bone metastases within 2 weeks before randomization;
- The toxicity of previous anti-tumor treatment has not recovered to s grade 1 level (except for hair loss and neurotoxicity);
- Known brain metastasis (except those who have received treatment and been stable for at least 24 weeks before randomization);
- Severe cardiac insufficiency,including congestive heart failure 2 grade 2 (New York Heart Association classification), myocardial infarction, stroke or transient ischemic attack (TIA) history within 6 months before enrollment; 14.History of ventricular tachycardia or torsade de pointes.Any clinically important abnormality in resting ECG rhythm, conduction,or morphology, such as QTcF \>450 msec in men or QTcF\>470 msec in women, the presence of complete left bundle branch block or third-degree atrioventricular block;
- 15. Pulmonary embolism or deep vein thrombosis occurred within 3months before randomization; 16.Uncontrolled hypertension(e.g.systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg)and uncontrolled diabetes ( baseline fasting blood glucose \>8.9 mmol/ L or glycosylated hemoglobin(HbA1C)\>6.5%); 17.There were uncontrolled active bacterial, viral,fungal,rickettsial or parasitic infections requiring intravenous anti-infective therapy within the first 2 weeks of randomization; 18.There were concurrent malignant tumors within the first 5 years of enrollment (except for fully treated cervical carcinoma in situ,localized skin squamous cell carcinoma,basal cell carcinoma, prostate cancer without anti-tumor treatment,thyroid cancer,breast ductal carcinoma in situ, and urothelial carcinoma below T1); 19. Known allergies to 68Ga-DOTATATE injection or 177Lu-DOTATATE injection or Octreotide LAR components and theirexcipients; 20. Any other disease or mental state that is not under control and may affect the completion of the study (including poor compliance) or is not suitable for the use of experimental drugs; 21.According to the patient \'s disease characteristics,the researchers believe that other treatment options (such as chemotherapy,targeted therapy) are more suitable for patients than the treatment provided in the study,that is,the experimental drugs are not the best therapeutic drugs in clinical practice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN
The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS
- Conditions
- NETS Ga68 Lu177
- Being tested
- 177Lu-DOTATATE injection, Octreotide LAR (Long-acting release)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTATATE injectionDrug
The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total.
Octreotide LAR (Long-acting release)Drug
The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-DOTATATE Injection | Experimental | Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total. Receives: Drug: 177Lu-DOTATATE injection |
| Octreotide LAR | Active comparator | Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days. Receives: Drug: Octreotide LAR (Long-acting release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Measured: 18 months from enrollment to PFS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start12 Dec 2023
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NETS Ga68 Lu177Studies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HTA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057622
- Sponsor's protocol ID
- YZGK-ZLYT-2023-Ⅲ-Lu
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN
- ClinicalTrials.gov ID
- NCT07057622
- Acronym / sponsor ID
- YZGK-ZLYT-2023-Ⅲ-Lu
- Conditions
- NETS Ga68 Lu177
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 10 Jul 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.
The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 177Lu-DOTATATE Injection | Experimental | Drug: 177Lu-DOTATATE injectionSubjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total. |
| Octreotide LAR | Active comparator | Drug: Octreotide LAR (Long-acting release)Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and the willingness to sign a written informed consent document;
- Age ≥18 years ;
- Low-and medium-grade ( G1 or G2) unresectable locally advanced or metastaticgastrointestinalneuroendocrine tumors(GEP-NETs)confirmed by histopatholog in the central laboratory,and those who had previously progressed after standard-dose somatostatin analogue(SSA)treatment;
- Somatostatin receptor positive patients must be defined as all target lesions at baseline confirmed by PET/ CT examination of gallium [68Ga] dobutamine injection as somatostatin receptor positive(IRC confirmed);
- There is at least one measurable lesion at baseline;
Key exclusion criteria (14 listed)
- Human immunodeficiency virus (HIV) antibody positive;
- Hepatitis B virus (HBV) surface antigen (HBsAg) is positive and HBV-DNA is positive (≥the upper limit of detection), or hepatitis C virus (HCV) antibody (HCV-Ab) is positive and HCV-RNA is positive (≥the upper limit of detection));
- Pregnant or lactating women;
- Received peptide receptor radionuclide therapy (PRRT) before randomization;
- Received Octreotide LAR treatment with a dose intensity \>30 mg/3-4 weeks (increased dose or frequency) within 12 weeks before randomization;
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 |
|---|---|---|
| 177Lu-DOTATATE injectionThe eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total. | Drug | 177Lu-DOTATATE Injection |
| Octreotide LAR (Long-acting release)The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days. | Drug | Octreotide LAR |
Primary outcome
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
Time frame: 18 months from enrollment to PFS
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 177Lu-DOTATATE injection and Octreotide LAR (Long-acting release) in people with NETS Ga68 Lu177, run by HTA Co., Ltd. at 1 site in China.
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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Li Huo, M.D. ((86)10-69158354, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the 18-month PFS rate of NET patients between 177Lu-DOTATATE Injection and long-acting octreotide (time frame: 18 months from enrollment to PFS). 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 10 Jul 2025.