A Phase 3 interventional study of [177Lu]Lu-DOTA-TATE and Octreotide LAR in Somatostatin Receptor Positive (SSTR+) and Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET), sponsored by Novartis Pharmaceuticals. Recruiting at 67 sites in 12 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of the current study is to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden
The study consists of a screening phase, a treatment phase and a follow-up phase. This study compares treatment with [177Lu]Lu-DOTA-TATE plus octreotide LAR and octreotide LAR only.
Participants with high disease burden in the Investigator's opinion. Following criteria should be used as the guiding principle for determining high disease burden:
RLI somatostatin receptor (SSTR) uptake on all target lesions (defined by RECIST v1.1 criteria) at least as high as normal liver uptake assessed within 3 months prior to randomization. Any of the RLI modalities as available (some examples are listed below) can be used as per local practice:
Adequate bone marrow and organ function as defined by the following laboratory values prior to receiving the first study treatment:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).
Radiation: [177Lu]Lu-DOTA-TATE · Drug: Octreotide LAR
Participants in this arm will receive Octreotide LAR only.
Drug: Octreotide LAR
\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
Octreotide LAR will be administered Q8W when co-administered with \[177Lu\]Lu-DOTA-TATE in the investigational arm followed by Q4W. In the control arm Octreotide LAR will be administered Q4W.
Also known as: SOM230
Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC)
PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.
Time frame: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start
Time to Deterioration (TDD) (Key Secondary)
Time to deterioration is defined as the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for each of the following domains (tested separately) of EORTC QLQ-GI.NET21 \[gastrointestinal scale (GI scale)\] and EORTC QLQ-C30 questionnaires (fatigue, diarrhea, and global health scale).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of progression (Investigator assessed according to RECIST v1.1) or death due to any cause.
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Objective Response Rate (ORR)
ORR: Rate of participants with best overall response (BOR) of partial response (PR) or complete response (CR) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Disease Control Rate (DCR)
DCR: Rate of participants with BOR of PR, CR or stable disease (SD) as per RECIST v1.1 (both Investigator and centrally assessed by BIRC).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Duration of Response (DOR)
DOR: The time from initially meeting the criteria for response (CR or PR) until the time of progression according to RECIST v1.1 or death due to underlying disease only.
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Overall Survival (OS)
OS: Time from the randomization date until the date of death due to any cause.
Time frame: Until 60 month from randomization
Time to Deterioration (TDD)
TTD is the time from randomization to the first occurrence of a deterioration compared to the baseline scores or death from any cause for EORTC QLQ-G.I.NET21 and EORTC QLQ-C30 domains not included among key secondary endpoints.
Time frame: At the time of primary PFS analysis after observing approximately 88 PFS events per BIRC assessment
Absolute change from baseline in EORTC QLQ-G.I.NET21 domain
Quality of Life assessed by EORTC QLQ-G.I.NET21 (excluding GI scale) (domains not included as key secondary objectives)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Absolute change from baseline in the EQ-5D-5L index at each time point
Quality of Life assessed by EQ-5D-5L
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Absolute change from baseline in EORTC QLQ-C30 domain
Quality of Life assessed by EORTC QLQ-C30 (domains not included as key secondary objectives)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start.
Dosimetry
Absorbed radiation dose in selected organs, tumor lesions and total body
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Pharmacokinetic (PK) parameter: Area Under Curve (AUC) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1). The AUC from time zero to infinity (mass x time x volume-1)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: Clearance from [177Lu]Lu-DOTA-TATE blood radioactivity data
Clearance is the total body clearance of drug from the plasma or blood (volume x time-1).
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: Distribution volume (Vz) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The apparent volume of distribution during terminal phase (associated with λz) (volume)
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
PK parameter: half-life (T1/2) from [177Lu]Lu-DOTA-TATE blood radioactivity data
The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives
Time frame: After observing approximately 88 PFS events as per BIRC assessment, expected after approximately 33 months from study start
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gastro-enteropancreatic neuroendocrine tumor→
Novartis Pharmaceuticals