Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

PHASE3RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

September 27, 2030

Study Completion Date

January 5, 2034

Conditions
Somatostatin Receptor Positive (SSTR+)Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
Interventions
RADIATION

[177Lu]Lu-DOTA-TATE

\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)

DRUG

Octreotide LAR

"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."

Trial Locations (45)

6720

RECRUITING

Novartis Investigative Site, Szeged

16132

RECRUITING

Novartis Investigative Site, Genova

20089

RECRUITING

Novartis Investigative Site, Rozzano

20141

RECRUITING

Novartis Investigative Site, Milan

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

23502

RECRUITING

Virginia Oncology Associates, Norfolk

24382

RECRUITING

Blue Ridge Cancer Center, Wytheville

27103

RECRUITING

Piedmont Healthcare, Winston-Salem

28034

RECRUITING

Novartis Investigative Site, Madrid

28040

RECRUITING

Novartis Investigative Site, Madrid

28041

RECRUITING

Novartis Investigative Site, Madrid

31059

RECRUITING

Novartis Investigative Site, Toulouse

33604

RECRUITING

Novartis Investigative Site, Pessac

34298

RECRUITING

Novartis Investigative Site, Montpellier

37007

RECRUITING

Novartis Investigative Site, Salamanca

44093

RECRUITING

Novartis Investigative Site, Nantes

44124

RECRUITING

Novartis Investigative Site, Cona

45147

RECRUITING

Novartis Investigative Site, Essen

56126

RECRUITING

Novartis Investigative Site, Pisa

69677

RECRUITING

Novartis Investigative Site, Bron

70112

RECRUITING

LSU Medical Center, New Orleans

72703

RECRUITING

Highlands Oncology Group, Fayetteville

75251

RECRUITING

Texas Oncology, Dallas

78705

WITHDRAWN

TxO Austin Midtown, Austin

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

91054

RECRUITING

Novartis Investigative Site, Erlangen

92110

RECRUITING

Novartis Investigative Site, Clichy

100036

RECRUITING

Novartis Investigative Site, Beijing

200032

RECRUITING

Novartis Investigative Site, Shanghai

06520

RECRUITING

Yale New Haven Hospital, New Haven

10029-6574

RECRUITING

Mount Sinai Medical Center, New York

N6A 5W9

RECRUITING

Novartis Investigative Site, London

M4N 3M5

RECRUITING

Novartis Investigative Site, Toronto

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

H-1083

RECRUITING

Novartis Investigative Site, Budapest

3584 CX

RECRUITING

Novartis Investigative Site, Utrecht

80-214

RECRUITING

Novartis Investigative Site, Gdansk

44 101

RECRUITING

Novartis Investigative Site, Gliwice

30-688

RECRUITING

Novartis Investigative Site, Krakow

60-355

RECRUITING

Novartis Investigative Site, Poznan

02-351

RECRUITING

Novartis Investigative Site, Warsaw

04-141

RECRUITING

Novartis Investigative Site, Warsaw

03080

RECRUITING

Novartis Investigative Site, Seoul

03722

RECRUITING

Novartis Investigative Site, Seoul

05505

RECRUITING

Novartis Investigative Site, Seoul

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY