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[68Ga]Ga-DOTA-TATE / Extensive Stage Small Cell Lung Cancer / Atezolizumab · Phase 1/2 Trial
ClinicalTrials.gov · August 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1b/2 trial of [177Lu]Lu-DOTA-TATE combined with carboplatin, etoposide, and atezolizumab in newly diagnosed ES-SCLC. No results are available in this registry record; the study is active but not recruiting and aims to establish a safe dose and preliminary efficacy against the chemotherapy-immunotherapy comparator.
Phase 1/2, Interventional, Randomized, Sequential, Open label, Treatment purpose. Extensive Stage Small Cell Lung Cancer; age from 18 Years; to 100 Years. Intervention: Dose Level 1 (DL1); Dose Level 2a (DL2a); Dose Level 2b (DL2b); Dose Level 3a (DL3a); Dose Level 3b (DL3b); Dose Level 4 (DL4); Phase II Experimental arm; Phase II Control arm. Compared with: Carboplatin, etoposide, and atezolizumab (Phase 2 only). n = 55. 30 sites across 12 countries.
This is a planned Phase 1b/2 trial of [177Lu]Lu-DOTA-TATE combined with carboplatin, etoposide, and atezolizumab in newly diagnosed ES-SCLC. No results are available in this registry record; the study is active but not recruiting and aims to establish a safe dose and preliminary efficacy against the chemotherapy-immunotherapy comparator.
Phase 1b dose-limiting toxicity thresholds and Phase 2 efficacy endpoints (e.g., hazard ratio, response rate) are not yet available.
This trial may establish whether radiopharmaceutical-augmented immunochemotherapy improves survival in ES-SCLC, a highly aggressive malignancy with limited treatment options. Clinicians should monitor publication of Phase 1b safety data and subsequent Phase 2 efficacy results.
This is an active interventional trial combining a radiopharmaceutical with chemotherapy and immunotherapy in ES-SCLC; no results are posted in this registry record, and the study aims only to establish safety and preliminary efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This trial may establish whether radiopharmaceutical-augmented immunochemotherapy improves survival in ES-SCLC, a highly aggressive malignancy with limited treatment options. Clinicians should monitor publication of Phase 1b safety data and subsequent Phase 2 efficacy results.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05142696). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 55 participants (ACTUAL). Conditions: Extensive Stage Small Cell Lung Cancer. Interventions: DRUG: [177Lu]Lu-DOTA-TATE; DRUG: Atezolizumab; DRUG: [68Ga]Ga-DOTA-TATE; OTHER: Carboplatin; OTHER: Etoposide. Primary outcome measures: Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation , Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment]; Phase ll: Overall survival (OS) , In the phase II part: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis). Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.