Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05142696 | A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab | PHASE1 | ACTIVE NOT_RECRUITING | 24 | — | — | Jul 13, 2022 | Mar 23, 2029 | May 29, 2026 | 39 | United States, Austria +14 |
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
| 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) |
| 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 |
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...