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Also known as [177Lu]Lu-DOTA-TATE
Lu-DOTA-TATE · 2 trials · 2 indications
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of \[177Lu\]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
To assess efficacy of \[177Lu\]Lu-DOTA-TATE in combination with atezolizumab, carboplatin, and etoposide (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that meets any of the criteria defining dose-limiting toxicities and with an onset during the DLT observation period specified for the group. • Group 1: DLT observation period of 49 to 52 days starting from the first administration of \[177Lu\]Lu-DOTA-TATE (Day 1) and ending with the completion of concomitant RT and TMZ. The 49 to 52 days observation period is depending on the start day of concomitant RT and TMZ (i.e. 7-10 days post first \[177Lu\]Lu-DOTA-TATE dose). If the concomitant RT and TMZ is delayed for any reason, the DLT observation period will last until the completion of the concomitant treatment. If RT or TMZ is delayed, the DLT observation period will last until the last administered dose, whichever occurs later.
A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that meets any of the criteria defining dose-limiting toxicities and with an onset during the DLT observation period specified for the group. • Group 3: DLT observation period of 42 days starting from the first administration of \[177Lu\]Lu-DOTA-TATE (Day 1) i.e. accounting for 2 cycles of Lu\]Lu-DOTA-TATE.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1 (DL1) | EXPERIMENTAL | Dose Level 1 (DL1): \[177Lu\]Lu-DOTA-TATE 100 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 100 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 2a (DL2a) | EXPERIMENTAL | Dose Level 2a (DL2a): \[177Lu\]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 150 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 2b (DL2b) | EXPERIMENTAL | Dose Level 2b (DL2b): \[177Lu\]Lu-DOTA-TATE 150 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumad 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 in the maintenance period. |
| Dose Level 3a (DL3a) | EXPERIMENTAL | Dose Level 3a (DL3a): \[177Lu\]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 200 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 3b (DL3b) | EXPERIMENTAL | Dose Level 3b (DL3b): \[177Lu\]Lu-DOTA-TATE 200 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3, and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Dose Level 4 (DL4) | EXPERIMENTAL | Dose Level 4 (DL4): \[177Lu\]Lu-DOTA-TATE 250 mCi with carboplatin AUC 5 D1, etoposide 100 mg/m2 D1-3 and atezolizumab 1200 mg in induction period, then \[177Lu\]Lu-DOTA-TATE 250 mCi plus atezolizumab 1200 mg in the maintenance period. |
| Phase II Experimental arm | EXPERIMENTAL | \[177Lu\]Lu-DOTA-TATE at recommended dose declared in phase I part in combination with carboplatin, etoposide and atezolizumab (experimental arm) |
| Phase II Control arm | OTHER | Carboplatin, etoposide and atezolizumab alone (control arm) |
| Group 1 - Newly diagnosed GB | EXPERIMENTAL | Participants with newly diagnosed glioblastoma will receive \[177Lu\]Lu-DOTA-TATE every 4 weeks +/- 2 days, starting 7 to 10 days prior to initiation of Radiotherapy (RT) and Temozolomide (TMZ) |
| Group 3 - Recurrent GB | EXPERIMENTAL | Participants with recurrent glioblastoma will receive \[177Lu\]Lu-DOTA-TATE as single agent therapy every 3 weeks +/- 2 days |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTA-TATE | DRUG | Solution for infusion of \[177Lu\]Lu-DOTA-TATE will be administered as follows: * 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3 * 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed |
| Atezolizumab | DRUG | Atezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period |
| [68Ga]Ga-DOTA-TATE | DRUG | 2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi) |
| Carboplatin | OTHER | Four cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period |
| Etoposide | OTHER | Four cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period |
| Temozolomide | OTHER | Concomitant Phase: Temozolomide 75mg/m2/d p.o until last day of EBRT. Maintenance Phase: Temozolomide p.o 150 mg/m2/d during cycle 1 then 200 mg/m2/d for the following cycles if tolerated well in Cycle 1. 6 cycles total (1 cycle = every 28 days) |
| Radiotherapy | OTHER | 2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks |
Key Inclusion Criteria: * Participant is \>= 18 years on the day of signing informed consent form * Histologically or cytologically confirmed ES-SCLC * Presence of measurable disease * No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of th...
Lu-DOTA-TATE, also known as [177Lu]Lu-DOTA-TATE, is an investigational small molecule being studied for the treatment of glioblastoma and extensive stage small cell lung cancer. It is currently in Phase 1 clinical development for these oncology indications.
The specific molecular target of Lu-DOTA-TATE is not disclosed in the available information. It is a small molecule therapeutic being investigated in oncology for glioblastoma and extensive stage small cell lung cancer.
Lu-DOTA-TATE is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma and extensive stage small cell lung cancer.
Lu-DOTA-TATE is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently active but not recruiting participants.
Lu-DOTA-TATE is being studied in two Phase 1 trials. NCT05109728 evaluates the drug in newly diagnosed glioblastoma combined with standard of care and in recurrent glioblastoma as a single agent. NCT05142696 studies it in newly diagnosed extensive stage small cell lung cancer combined with carboplatin, etoposide, and atezolizumab.
Yes, Lu-DOTA-TATE is also known as [177Lu]Lu-DOTA-TATE. Both names refer to the same investigational drug being developed by Novartis AG for the treatment of glioblastoma and extensive stage small cell lung cancer.