Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07172412
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extensive Stage Lung Small Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor 60 mg biw q21d
  • Anlotinib — DRUG
    Anlotinib 12mg d1-14 qd PO
  • DLL3 CAR-NK cells — BIOLOGICAL
    1.0×10\^9 DLL3-CAR-NK+ cells d5 q6w
  • Etoposide + Cisplatin/Carboplatin — DRUG
    Etoposide 100mg/m\^2 d1-3+ cisplatin 75mg/m\^2 d1-3 or Carboplatin AUC5
  • Tislelizumab/Atezolizumab/ Durvalumab/Benmelstobart/Toripalimab/Serplulimab — DRUG
    Use immunotherapy according to the standard immunotherapy-combined-chemotherapy protocol.

Study Details

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).

Key Dates

Start date
Nov 30, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
165 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib TEAM
    Anlotinib+SOC therapy
  • Experimental: DLL3 TEAM
    DLL3 CAR-NK cell+SOC therapy
  • Experimental: XPO1 TEAM
    Selinexor+SOC therapy

Primary Outcome Measure

PFS [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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