177Lu-DOTA-TATE + Octreotide LAR for Neuroendocrine Tumors

(NETTER-3 Trial)

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Somatostatin analogues

Must not be taking: Interferons, mTOR-inhibitors, Chemotherapy

Disqualifiers: Brain metastases, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 33 months

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for patients with advanced Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have a high disease burden. Eligible participants should have large primary tumors or metastases, elevated alkaline phosphatase levels, peritoneal metastasis, symptoms like pain and weight loss, bone metastasis, hormone excess symptoms needing management, and be diagnosed within the last 6 months.

Inclusion Criteria

My doctor thinks my cancer has spread a lot.

My cancer has spread to my bones.

I am 12 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive [177Lu]Lu-DOTA-TATE plus octreotide LAR or octreotide LAR alone

33 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for overall survival and other long-term outcomes

60 months

Treatment Details

Interventions

• [177Lu]Lu-DOTA-TATE

Trial Overview [177Lu]Lu-DOTA-TATE combined with octreotide LAR is being tested against octreotide LAR alone in patients with somatostatin receptor positive GEP-NETs. The study aims to determine which treatment is more effective and safer for managing these types of tumors that are unresectable and show signs of aggressive growth.

Participant Groups

Group I: [177Lu]Lu-DOTA-TATE + Octreotide LAR Experimental Treatment 2 Interventions

Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).

Group II: Octreotide LAR Active Control 1 Intervention

Participants in this arm will receive Octreotide LAR only.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD