Clinical trial · Interventional
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination With Carboplatin, Etoposide, and Atezolizumab in Induction and With Atezolizumab in Maintenance Phase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [177Lu]Lu-DOTA-TATE | Drug | — | UNRESOLVED |
| [68Ga]Ga-DOTA-TATE | Drug | — | UNRESOLVED |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Carboplatin | Other | — | UNRESOLVED |
| Etoposide | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Dose Level 1 (DL1)
- description
- 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.
- interventionNames
- Drug: [177Lu]Lu-DOTA-TATE
- Drug: Atezolizumab
- Drug: [68Ga]Ga-DOTA-TATE
- Other: Carboplatin
- Other: Etoposide
- type
- EXPERIMENTAL
- label
- Dose Level 2a (DL2a)
- description
- 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.
- interventionNames
- Drug: [177Lu]Lu-DOTA-TATE
- Drug: Atezolizumab
- Drug: [68Ga]Ga-DOTA-TATE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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 the induction period * ECOG status =\< 1 * Provision of tumor tissue to support exploratory biomarker analysis * Life expectancy of \>= 6 months Key Exclusion Criteria: * Participant has received prior therapy with an antibody or drug against immune checkpoint pathways * Active autoimmune diseases or history of autoimmune diseases that may relapse * Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1 * Any major surgical procedure requiring general anesthesia =\< 28 days before Cycle 1 Day 1 * History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study * Known hypersensitivity to the active substances or any of the excipients of the study drugs * Concurrent participation in another therapeutic clinical study
References
Publications (0)
Data not yet available