Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy

Sponsor
Baohui Han
Study ID
NCT06332950
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Adebrelimab, Irinotecan Liposome (II) — DRUG
    Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Escalating doses to determine recommended phase 2 dose (RP2D) of Irinotecan Liposome (II). Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II).
  • Adebrelimab, Irinotecan Liposome (II), Famitinib — DRUG
    Adebrelimab:1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD Escalating doses to determine recommended phase 2 dose (RP2D) of Famitinib. Participants will receive Adebrelimab (1200 mg, IV, D1, Q3W) plus the RP2D of Irinotecan Liposome (II) and Famitinib.

Study Details

This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2024
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab plus Irinotecan Liposome (II)
    Adebrelimab: 1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W
  • Experimental: Adebrelimab plus Irinotecan Liposome (II) and Famitinib
    Adebrelimab: 1200 mg, IV, D1, Q3W Irinotecan Liposome (II): RP2D, IV, D1, Q3W Famitinib: RP2D, QO, QD

Primary Outcome Measure

6-month progression-free survival [ Time Frame: Up to 6 months ]

Central Contacts

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