Progression Free Survival (PFS) Per Central Assessment
| Group | Value (months) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 22.8 |
| Octreotide LAR 60 mg (Control Arm) | 8.5 |
Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataShort name NETTER-2
United States, Canada, France, Germany, Italy, Netherlands, South Korea, Spain, United Kingdom
1 trial · 1 ongoing · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The aim of NETTER-2 was to determine if Lutathera in combination with long-acting octreotide prolongs progression free survival (PFS) in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients were eligible, as well as patients previously treated with SSAs in the absence of progression.
Experimental
Lutathera® plus Octreotide LAR 30 mg (Investigational arm)
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.
Active comparator
Octreotide LAR 60 mg (Control arm)
Participants were administered with octreotide LAR 60 mg (Sandostatin LAR Depot) at 4-week intervals until the completion of the Treatment Phase.
Experimental
Optional post-progression re-treatment with Lutathera
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)
Active comparator
Optional post-progression cross-over to Lutathera
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).
Active comparator
Optional post-progression re-treatment with Lutathera after cross-over
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).
Outcomes the sponsor listed as primary.
Progression Free Survival (PFS) Per Central Assessment
Time frame · from randomization to the first line progression or death due to any cause, up to approx. 42 months
PFS is the time from randomization to the first line progression (centrally assessed according to RECIST 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumor Criteria (RECIST 1.1) as a 20% increase in the sum of diameters of all measured target lesions or unequivocal progression of non-target lesions or appearance of a new lesion.
Overall Response Rate (ORR) Per Central Assessment (Key Secondary)
Time frame · Up to approx. 42 months
ORR is defined as the percentage of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time to Deteriration (TTD) Global Health Status, Diarrhea, Fatigue, Pain (EORTC QLQ-C30) (Key Secondary)
Time frame · Up to approx. 42 months
TTD is defined as the first deterioration of at least 10 points from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): global health status, diarrhea, fatigue, and pain. The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Disease Control Rate (DCR) Per Central Assessment
Time frame · Up to approx. 42 months
Disease Control Rate is the percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD) (centrally assessed according to RECIST 1.1). CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD).
Duration of Response (DOR) Per Central Assessment
Time frame · Up to approx. 42 months
Duration of Response defined as time from first complete or partial response to progression or death due to underlying cancer according to RECIST 1.1.
Rate of Adverse Events
Time frame · from FPFV until end of study (about 94 months)
Rate of adverse events scored according to CTCAE grade
Rate of Laboratory Toxicities
Time frame · from FPFV until end of study (about 94 months)
Rate of laboratory toxicities scored according to CTCAE grade
Overall Survival (OS)
Time frame · from FPFV until end of study (about 94 months)
OS is the time from randomization date until day of death due to any cause.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 22.8 |
| Octreotide LAR 60 mg (Control Arm) | 8.5 |
| Group | Value (Percentage of participants) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 43.0 |
| Octreotide LAR 60 mg (Control Arm) | 9.3 |
| Group | Value (months) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 13.2 |
| Octreotide LAR 60 mg (Control Arm) | 8.6 |
| Group | Value (Percentage of participants) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 90.7 |
| Octreotide LAR 60 mg (Control Arm) | 66.7 |
| Group | Value (months) |
|---|---|
| Lutathera® Plus Octreotide LAR 30 mg (Investigational Arm) | 23.3 |
| Octreotide LAR 60 mg (Control Arm) | NA |
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Value |
|---|
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lutathera® Plus Octreotide LAR 30 mgLutathera 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. | 32 / 147 | 30 / 147 | 129 / 147 |
| Octreotide LAR 60 mg (Control Arm)Participants were administered with octreotide LAR 60 mg (Sandostatin LAR Depot) at 4-week intervals until the completion of the Treatment Phase. | 14 / 73 | 15 / 73 | 65 / 73 |
| Crossover LutatheraParticipants who received Octreotide LAR in Active comparator Arm and who progressed and met cross over eligibility criteria received maximum 4 cycles of Lutathera (7.4 GBq/200 mCi x 4 cycles) plus octreotide long-acting (30 mg every 8 weeks) | 3 / 29 | 2 / 29 | 22 / 29 |
| Re-Treatment LutatheraParticipants 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) | 0 / 8 | 0 / 8 | 6 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
0 studies on this page
Indexing hint: Randomized controlled trial · 2024
Singh et al. 2024Lancet (London, England)cited by 300
PMID 38851203DOI 10.1016/s0140-6736(24)00701-3PUB-38851203
1 study on this page
PubMed tag: none · 2024
Bahri et al. 2024Oncology (Williston Park, N.Y.)
PMID 39570708DOI 10.46883/2024.25921029PUB-39570708
References listed at the registry that are not in PepBank. They link to PubMed.
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