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

NCT05459844 | Active Not Recruiting Phase 3

• 1 other identifier: XT-XTR008-3-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine tumour; 177Lu-Dota0-Tyr3-octreotate

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by BIRC

  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).

  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

Secondary Outcomes (15)

• Progression Free Survival (PFS) assessed by investigator

  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

• Objective Response Rate (ORR) assessed by investigator

  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) assessed by BIRC

  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

• Duration of Response (DoR) assessed by investigator

  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

• Duration of Response (DoR) assessed by BIRC

  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

Study Arms (2)

Lutetium[177Lu] Oxodotreotide Injection

EXPERIMENTAL

Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) Lutetium\[177Lu\] Oxodotreotide Injection: Four administrations of 7.4 GBq (200 mCi). Concomitant amino acids were given with each administration for kidney protection. Lutetium\[177Lu\] Oxodotreotide Injection was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed.

Drug: Lutetium[177Lu] Oxodotreotide Injection

Octreotide LAR

ACTIVE COMPARATOR

60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed.

Drug: Octreotide LAR

Interventions

Lutetium[177Lu] Oxodotreotide Injection DRUG

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.

Also known as: 177Lu-DOTA0-Tyr3-Octreotate

Lutetium[177Lu] Oxodotreotide Injection

Octreotide LAR DRUG

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.

Also known as: SANDOSTATIN LAR, Octreotide

Octreotide LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Aged 18 years or older.
• 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).
• Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression.
• 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).
• Presence of at least 1 measurable site of disease (based on RECIST 1.1).
• All target lesions (based on RECIST 1.1) at baseline must be confirmed as somatostatin receptor positive by 68Ga-Dotatate PET/CT .
• ECOG score of 0 or 1.
• 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.

You may not qualify if:

• Serum creatinine \>150 μmol/L (1.7 mg/dL) or creatinine clearance \<50 ml/min (Cockcroft Gault formula).
• Hemoglobin \<80g/L, or white blood cell count \<2.0×10\^9/L, or platelets \<75×10\^9/L.
• Serum total bilirubin \> 3 × upper limit of normal (ULN).
• Serum albumin \<30g/L.
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5×ULN.
• international normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 x ULN.
• Positive human immunodeficiency virus (HIV) antibody.
• 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.
• Pregnant or lactating females.
• Received peptide receptor radionuclide therapy(PRRT) prior to randomization.
• Received Octreotide LAR at a dose strength \>30 mg/3-4 weeks (increasing dose or frequency) within 12 weeks prior to randomization.
• 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.
• Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.
• Participated in other drug clinical trials within 4 weeks prior to randomization and received treatment with the corresponding trial drug.
• 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.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (23)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The First Afilliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

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

Wuhan, Hubei, 430030, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of AFMU

Xi'an, Shaanxi, 710032, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030012, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 39607652 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate; Octreotide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jianming Xu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 15, 2022
• Study Start: August 31, 2022
• Primary Completion: June 26, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (23)