Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT06784752
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET)
- Somatostatin Receptor Positive (SSTR+)
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- [177Lu]Lu-DOTA-TATE — RADIATION\[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W)
- Octreotide LAR — DRUGOctreotide 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.
Study Details
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
Key Dates
- Start date
- May 30, 2025
- Status verified
- Apr 2026
- Primary completion
- Dec 8, 2028
- Completion
- Jan 23, 2034
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: [177Lu]Lu-DOTA-TATE + Octreotide LARParticipants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR).
- Active Comparator: Octreotide LARParticipants in this arm will receive Octreotide LAR only.
Primary Outcome Measure
Progression Free Survival (PFS) centrally assessed by Blinded Independent Review Committee (BIRC) [ Time Frame: After observing approximately 88 PFS events as per BIRC assessments, expected after approximately 33 months from study start ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | Mohamad Sonbol (PRINCIPAL_INVESTIGATOR) |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | Joseph Thaddeus Beck (PRINCIPAL_INVESTIGATOR) |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Allen Cohn (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | Hayley Dunnack Andrew Salner (PRINCIPAL_INVESTIGATOR) |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | Melissa George Pamela Kunz (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | Jason Starr (PRINCIPAL_INVESTIGATOR) |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | Amol Takalkar (PRINCIPAL_INVESTIGATOR) |
| St Elizabeth Healthcare | Edgewood | Kentucky | 41017 | Lauren Willett Minsig Choi (PRINCIPAL_INVESTIGATOR) |
| LSU Medical Center | New Orleans | Louisiana | 70112 | Taylor Green Mary Maluccio (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202-2689 | Philip A Philip (PRINCIPAL_INVESTIGATOR) |
| Mount Sinai Medical Center | New York | New York | 10029-6574 | Edward Wolin (PRINCIPAL_INVESTIGATOR) |
| Piedmont Healthcare | Winston-Salem | North Carolina | 27103 | Jeff Whorton Eyal Meiri (PRINCIPAL_INVESTIGATOR) |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Chasity McHone Joseph Merriman (PRINCIPAL_INVESTIGATOR) |
| TxO Austin Midtown | Austin | Texas | 78705 | - |
| Texas Oncology | Dallas | Texas | 75251 | Danielle Koetter Scott Scott Paulson (PRINCIPAL_INVESTIGATOR) |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Kristi Ben-Barka Gregory Scott Sibley (PRINCIPAL_INVESTIGATOR) |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Amber Ingram Jedrzej Wykretowicz (PRINCIPAL_INVESTIGATOR) |
| Blue Ridge Cancer Center | Wytheville | Virginia | 24382 | Natasha Holt David Buck (PRINCIPAL_INVESTIGATOR) |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | Mohammed N Kanaan (PRINCIPAL_INVESTIGATOR) |