Lutathera for Neuroendocrine Tumors
(NETTER-2 Trial)

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Advanced Accelerator Applications

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if a combination of targeted radiation therapy and a hormone-like drug can slow down disease progression in patients with fast-growing gastroenteropancreatic neuroendocrine tumors. The treatment aims to deliver radiation directly to cancer cells while using the hormone-like drug to manage symptoms and slow tumor growth. The study includes patients who have not previously used similar treatments or have used them without their disease getting worse.

Eligibility Criteria

This trial is for adults and adolescents (15 years or older, over 40 kg) with advanced Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine tumors (GEP-NET), diagnosed within the last 6 months. Participants must have a certain level of tumor cell proliferation (Ki67 index ≥10 and ≤55%), express somatostatin receptors on all target lesions, and have a Karnofsky Performance Score of at least 60. Pregnant women, those unable to use effective contraception, or patients who've had certain prior treatments are excluded.

Inclusion Criteria

The tumor uptake observed in the target lesions must be > normal liver uptake

My GEP-NET tumor is advanced, cannot be removed by surgery, and was diagnosed within the last 6 months.

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Exclusion Criteria

Total bilirubin > 3 x ULN

Patients for whom in the opinion of the investigator other therapeutic options (eg chemo-, targeted therapy) are considered more appropriate than therapy offered in the study, based on patient and disease characteristics

My potassium levels are high and not corrected before joining the study.

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Treatment Details

Interventions

high dose long-acting octreotide (Somatostatin Analog)
long-acting octreotide (Somatostatin Analog)
Lutathera (Radioactive Drug)

Trial OverviewThe NETTER-2 study tests whether Lutathera combined with long-acting octreotide can extend the time without disease progression in GEP-NET patients compared to high-dose long-acting octreotide alone. It's designed for first-line treatment; some participants may cross over to Lutathera after progression or receive re-treatment.

Participant Groups

5Treatment groups

Experimental Treatment

Active Control

Group I: Optional post-progression re-treatment with LutatheraExperimental Treatment1 Intervention

Participants who received Lutathera in experimental arm and who progressed and met re-treatment eligibility criteria received additional 2 - 4 cycles of Lutathera (7.4 GBq/200 mCi x 4 cycles)

Group II: Lutathera® plus Octreotide LAR 30 mg (Investigational arm)Experimental Treatment3 Interventions

Lutathera treatment consisted of a cumulative administered radioactivity of 29.6 GBq (800mCi) (7.4 GBq/200 mCi x 4 administrations every 8 +/- 1 week). Participants in the Lutathera arm were concomitantly administered with octreotide LAR 30 mg (Sandostatin LAR Depot) the day after each administration of Lutathera and no earlier than 4 hours after completion of the Lutathera infusion. Once Lutathera treatment completed, participants continued the 4-week interval administrations of 30 mg octreotide LAR until the completion of the Treatment Phase. Concomitantly with Lutathera, sterile amino acid solution was administered to minimize renal radiation exposure during Lutathera treatment.

Group III: Octreotide LAR 60 mg (Control arm)Active Control1 Intervention

Participants were administered with octreotide LAR 60 mg (Sandostatin LAR Depot) at 4-week intervals until the completion of the Treatment Phase.

Group IV: Optional post-progression cross-over to LutatheraActive Control1 Intervention

Participants who received Octreotide LAR in Active comparator arm and who progressed and met cross-over eligibility criteria received maximum 4 cycles of Lutaathera (7.4 GBq/200 mCi x 4 cycles) plus octreotide long-acting (30 mg every 8 weeks).

Group V: Optional post-progression re-treatment with Lutathera after cross-overActive Control2 Interventions

Participants who received Octreotide LAR in Active comparator arm subsequently entered cross-over, received Lutathera in cross-over, progressed for the second time and met re-treatment eligibility criteria could receive additional 2 - 4 cycles of Lutathera (7.4 GBq/200 mCi x 4 cycles).