Small Cell Lung Cancer

P2, N=36, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.

P3, N=120, Recruiting, Pharmacosmos A/S | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Jun 2026

The TMEp phase integrated stereotactic body radiotherapy (SBRT), low-dose etoposide, and anlotinib, followed by CI with the programmed death 1 (PD-1)/cytotoxic T lymphocyte antigen 4 (CTLA-4) bispecific antibody cadonilimab and concurrent probiotic supplementation...The TMEp-CI-M platform may enhance the efficacy of immunotherapy in ES-SCLC, enabling durable responses even in patients with brainstem metastases. Although this platform has demonstrated promise across multiple tumor types, further prospective and mechanistic studies are warranted to confirm its clinical utility.

P=N/A, N=440, Recruiting, BeOne Medicines

P1/2, N=125, Completed, Xilio Development, Inc. | Active, not recruiting --> Completed

P1/2, N=156, Completed, National Cancer Institute (NCI) | Phase classification: P2 --> P1/2

P2, N=9, Active, not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Dec 2026

Tarlatamab, a representative agent in this class, has been approved for clinical use, and multiple TCE agents are currently under clinical development. Although DLL3-TCE shows promising prospects in the clinical management of SCLC, as a novel therapeutic modality, many clinicians still lack an in-depth understanding of their mechanisms of action, appropriate patient populations, and clinical management. To standardize the clinical application of DLL3-TCE in China, the Small Cell Lung Cancer Expert Committee of the Chinese Society of Clinical Oncology convened a consensus panel to develop the Chinese Expert Consensus on Delta-like Ligand 3-T Cell Engager Therapy for SCLC based on evidence-based medicine and expert practical experience, with the aim of providing standardized guidance for the clinical use of DLL3-TCE agents..

This paper reported a case of concurrent SCLC transformation and ALK fusion occurring after Osimertinib treatment, suggesting that the two can coexist as dual drug resistance mechanisms. Re-biopsy combined with genetic testing is essential for identifying drug resistance mechanisms and guiding individualized therapy..

P=N/A, N=100, Recruiting, University of California, Davis | Trial completion date: Jan 2031 --> Jan 2032 | Trial primary completion date: Dec 2025 --> Dec 2026

Although combined SCLC with three NSCLC components is exceedingly rare, this case provides novel insights into lineage diversification and the clonal evolution and biological diversity of combined SCLC. Further accumulation of similar cases with integrated molecular analyses is warranted to improve understanding of this rare subtype and inform future therapeutic strategies.