NCT05361395

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Active, enrolled Phase 1 Last updated 3 March 2026

What this trial tests

Phase 1 trial testing Tarlatamab in Extensive Stage Small Cell Lung Cancer in 184 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 August 2022

Primary endpoint
28 August 2028

28 August 2028

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	184
Start date	24 August 2022
Primary completion	28 August 2028
Estimated completion	28 August 2028
Sites	44 locations across Denmark, France, Italy, Japan, Netherlands, Belgium, Taiwan, Germany

Drugs / interventions tested

• Tarlatamab
• Carboplatin (Carboplatin) — full drug profile →
• Etoposide (etoposide) — full drug profile →
• Atezolizumab (atezolizumab) — full drug profile →
• Durvalumab — full drug profile →

Conditions studied

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

Sponsor

Amgen — full company profile →

Who can join

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

Sponsor's own description

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

Publications & conference data

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

1. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study.
   Paz-Ares L, Champiat S, Lai WV, Izumi H, et al · · 2023 · cited 221× · PMID 36689692 · DOI 10.1200/jco.22.02823
2. Emerging therapies targeting the delta-like ligand 3 (DLL3) in small cell lung cancer.
   Rudin CM, Reck M, Johnson ML, Blackhall F, et al · · 2023 · cited 112× · PMID 37355629 · DOI 10.1186/s13045-023-01464-y
3. Antibodies to watch in 2025.
   Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
4. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study.
   Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, et al · · 2024 · cited 36× · PMID 38811992 · DOI 10.1186/s12943-024-02014-x
5. DLL3-guided therapies in small-cell lung cancer: from antibody-drug conjugate to precision immunotherapy and radioimmunotherapy.
   Su PL, Chakravarthy K, Furuya N, Brownstein J, et al · · 2024 · cited 33× · PMID 38730427 · DOI 10.1186/s12943-024-02012-z
6. Cancer stem cells: a target for overcoming therapeutic resistance and relapse.
   Zhang S, Yang R, Ouyang Y, Shen Y, et al · · 2024 · cited 20× · PMID 38164743 · DOI 10.20892/j.issn.2095-3941.2023.0333
7. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
   Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
8. Insights into next-generation immunotherapy designs and tools: molecular mechanisms and therapeutic prospects.
   Qin H, Zhou Z, Shi R, Mai Y, et al · · 2025 · cited 15× · PMID 40483473 · DOI 10.1186/s13045-025-01701-6