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NCT05459844·Phase 3·INTERVENTIONAL

A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

OctreotideOtherActive, not recruiting

Status

Active, not recruiting

Phase

Phase 3

Enrollment

196

Locations

23

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium\[177Lu\] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

Full detailed description

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium\[177Lu\] Oxodotreotide Injection or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by primary site of tumor (pancreatic or non-pancreatic), NET pathological grading (G1 or G2) and by the length of time that a participant was on a constant dose of Octreotide (=\< 6 versus \> 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: any participants with progressive disease ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.

Interventions

Treatment arms and agents.

DRUG

Lutetium[177Lu] Oxodotreotide Injection

Four administrations of 7.4 GBq (200 mCi) Lutetium\[177Lu\] Oxodotreotide Injection administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

DRUG

Octreotide LAR

60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.

Timeline

From registration to results.

  1. First posted

    Jul 15, 2022

  2. Study start

    Aug 31, 2022

  3. Primary completion

    Jun 26, 2024

  4. Study completion

    Dec 2028

  5. Results posted

    Not reported

  6. Registry updated

    Sep 5, 2025

Outcomes

What the study measures.

Primary outcomes

Progression Free Survival (PFS) assessed by BIRC

Time frame · From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Blinded Independent Review Committee (BIRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Secondary outcomes

Progression Free Survival (PFS) assessed by investigator

Time frame · From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Progression Free Survival (PFS) was defined as the time from randomization to documented investigator-assessed disease progression, or death due to any cause. If a participant had no investigator-assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Objective Response Rate (ORR) assessed by investigator

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) and assessed by investigator according to RECIST 1.1.

Objective Response Rate (ORR) assessed by BIRC

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) assessed by BIRC according to RECIST 1.1.

Duration of Response (DoR) assessed by investigator

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression and assessed by investigator according to RECIST 1.1.

Duration of Response (DoR) assessed by BIRC

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression assessed by BIRC according to RECIST v1.1.

Time to Tumour Progression (TTP) assessed by investigator

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Time to Tumour Progression (TTP) was defined as the time from randomization to progression assessed by investigator. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).

Time to Tumour Progression (TTP) assessed by BIRC

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

Time to Tumour Progression (TTP) was defined as the time from randomization to progression assessed by BIRC. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).

Disease Control Rate (DCR) assessed by investigator

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

DCR is defined as the incidence of complete response, partial response and stable disease assessed by investigator according to RECIST v1.1.

Disease Control Rate (DCR) assessed by BIRC

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

DCR is defined as the incidence of complete response, partial response and stable disease assessed by BIRC according to RECIST v1.1.

20-month Progression-Free Survival rate assessed by BIRC

Time frame · From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months

20-month Progression-Free Survival rate was defined as the proportion of patients whose time from randomization to disease progression by BIRC according to RECIST v1.1 or death exceeds 20 months.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Aged 18 years or older. 3. Histopathologically confirmed low and moderate grade (G1 or G2) unresectable locally advanced or metastatic GEP-NET (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine tumors of the digestive system in 2019, to be centrally confirmed). 4. Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression. 5. Presence of disease progression prior to randomization (time point of disease progression limited to 1 year prior to randomization and no other antitumor therapy received after progression). 6. Presence of at least 1 measurable site of disease (based on RECIST 1.1). 7. All target lesions (based on RECIST 1.1) at baseline must be confirmed as somatostatin receptor positive by 68Ga-Dotatate PET/CT . 8. ECOG score of 0 or 1. 9. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 4 months (men) or 7 months (women) of the last use of the trial drug. Exclusion Criteria: 1. Serum creatinine \>150 μmol/L (1.7 mg/dL) or creatinine clearance \<50 ml/min (Cockcroft Gault formula). 2. Hemoglobin \<80g/L, or white blood cell count \<2.0×10\^9/L, or platelets \<75×10\^9/L. 3. Serum total bilirubin \> 3 × upper limit of normal (ULN). 4. Serum albumin \<30g/L. 5. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5×ULN. 6. international normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 x ULN. 7. Positive human immunodeficiency virus (HIV) antibody. 8. Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and positive for HBV DNA (≥1×10\^4 copies/ml or judged positive by research center criteria), or positive for hepatitis C virus (HCV) antibodies. 9. Pregnant or lactating females. 10. Received peptide receptor radionuclide therapy(PRRT) prior to randomization. 11. Received Octreotide LAR at a dose strength \>30 mg/3-4 weeks (increasing dose or frequency) within 12 weeks prior to randomization. 12. Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of Lutetium\[177Lu\] Oxodotreotide Injection, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of Lutetium\[177Lu\] Oxodotreotide Injection. 13. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization. 14. Participated in other drug clinical trials within 4 weeks prior to randomization and received treatment with the corresponding trial drug. 15. Received the following treatments within 12 weeks prior to randomization, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation. 16. Received external beam radiation therapy for bone metastases within 2 weeks prior to randomization 17. Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia) 18. Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. 19. Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \<50%. 20. uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN. 21. Any clinically significant active infection. 22. Known other malignancies (except for those without recurrence within 5 years after adequate treatment) 23. Known hypersensitivity to Lutetium\[177Lu\] Oxodotreotide Injection or oxytetracycline acetate microsphere components and their excipients. 24. Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency. 25. Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug. 26. Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics, i.e., the investigational drug is not the best therapeutic agent for clinical practice.

Study locations

23 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The First Afilliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The first hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of AFMU

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Publications

Results and literature.

PMID 41739362 ↗Liu F, Yang H, Zhang J, Li J, Qiao Y, Chen J, Song S. Relationship between absorbed dose and SUV derived from SPECT/CT imaging and dose-response in patients with neuroendocrine tumors treated with [(1)(7)(7)Lu]Lu-DOTA-TATE. EJNMMI Res. 2026 Feb 25;16(1):52. doi: 10.1186/s13550-026-01402-2.PMID 39607652 ↗Liu F, Li P, Xu J, Zhang J, Xu X, Chen Z, Qiao Y, Liang Y, Chen J, Song S. Radiation exposure and protection advice after [177Lu]Lu-DOTA-TATE therapy in China. EJNMMI Res. 2024 Nov 28;14(1):119. doi: 10.1186/s13550-024-01185-4.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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