An Umbrella Ib/II Phase Study Evaluating the Efficacy and Safety of First-Line Combination Therapy in the Treatment of Extensive-Stage Small Cell Lung Cancer

NCT07172412 Phase 2 NOT_YET_RECRUITING

This is an open-label umbrella study conducted in first treatment ES-SCLC patients, employing a novel umbrella trial design (biomarker-integrated multi-arm trial with a shared ICI+chemotherapy control arm). Eligible patients were assigned to trial arms based on biomarker expression levels. Biomarker subgroups were defined as: (1) High ASCL1/NEUROD1/DLL3 expression: DLL3-CAR-NK cells combined with ICI + etoposide + carboplatin (DLL3 group); (2) Myc overexpression: XPO1 inhibitor selinexor combined with ICI + etoposide + carboplatin (XPO1 group); (3) VIM/AXL high expression group treated with anlotinib combined with ICI + etoposide + carboplatin (anlotinib group).

Details

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	165
Start date	2025-11
Completion	2028-12

Conditions

• Extensive Stage Lung Small Cell Cancer

Interventions

• Selinexor
• Anlotinib
• DLL3 CAR-NK cells
• Etoposide + Cisplatin/Carboplatin
• Tislelizumab/Atezolizumab/ Durvalumab/Benmelstobart/Toripalimab/Serplulimab

Primary outcomes

• PFS — through study completion, an average of 1 year
• ORR — through study completion, an average of 1 year
• OS — through study completion, an average of 1 year

Countries

China