NCT05142696

A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

Active, enrolled Phase 1, PHASE2 Last updated 17 March 2026

What this trial tests

Phase 1, PHASE2 trial testing [177Lu]Lu-DOTA-TATE in Extensive Stage Small Cell Lung Cancer in 24 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 July 2022

Primary endpoint
9 March 2029

23 March 2029

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	13 July 2022
Primary completion	9 March 2029
Estimated completion	23 March 2029
Sites	40 locations across France, Hong Kong, Italy, Netherlands, Austria, Taiwan, United Kingdom, Germany

Drugs / interventions tested

• [177Lu]Lu-DOTA-TATE — full drug profile →
• Atezolizumab (atezolizumab) — full drug profile →
• [68Ga]Ga-DOTA-TATE
• Carboplatin (Carboplatin) — full drug profile →
• Etoposide (etoposide) — full drug profile →

Conditions studied

• Extensive Stage Small Cell Lung Cancer — all drugs for Extensive Stage Small Cell Lung Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Extensive Stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiotheranostics in oncology: current challenges and emerging opportunities.
   Bodei L, Herrmann K, Schöder H, Scott AM, et al · · 2022 · cited 251× · PMID 35725926 · DOI 10.1038/s41571-022-00652-y
2. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
3. Lutathera^® Orphans: State of the Art and Future Application of Radioligand Therapy with ¹⁷⁷Lu-DOTATATE.
   Urso L, Nieri A, Uccelli L, Castello A, et al · · 2023 · cited 29× · PMID 37111596 · DOI 10.3390/pharmaceutics15041110
4. Peptide receptor radionuclide therapy combinations for neuroendocrine tumours in ongoing clinical trials: status 2023.
   di Santo G, Santo G, Sviridenko A, Virgolini I. · · 2024 · cited 24× · PMID 38250038 · DOI 10.7150/thno.91268
5. Radiopharmaceuticals as combinatorial partners for immune checkpoint inhibitors.
   Pouget JP, Chan TA, Galluzzi L, Constanzo J. · · 2023 · cited 19× · PMID 37612188 · DOI 10.1016/j.trecan.2023.07.014
6. Innovation in Radionuclide Therapy for the Treatment of Prostate Cancers: Radiochemical Perspective and Recent Therapeutic Practices.
   Deshayes E, Fersing C, Thibault C, Roumiguie M, et al · · 2023 · cited 11× · PMID 37370743 · DOI 10.3390/cancers15123133
7. Peptide receptor radionuclide therapy with somatostatin analogs beyond gastroenteropancreatic neuroendocrine tumors.
   Santo G, di Santo G, Cicone F, Virgolini I. · · 2025 · cited 10× · PMID 40064181 · DOI 10.1111/jne.70013
8. First-Line Treatment for Advanced SCLC: What Is Left Behind and Beyond Chemoimmunotherapy.
   Giunta EF, Addeo A, Rizzo A, Banna GL. · · 2022 · cited 10× · PMID 35692538 · DOI 10.3389/fmed.2022.924853