Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC

Sponsor
Sichuan University
Study ID
NCT06769971
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Ivonescimab — DRUG
    20mg/kg，IV infusion，Day1，Q3W
  • Cadonilimab — DRUG
    10mg/kg，IV infusion，Day8，Q6W
  • Etoposide — DRUG
    100mg/kg，IV infusion，Day1-3，Q3W
  • Carboplatin — DRUG
    AUC 5，IV infusion，Day1，Q3W

Study Details

This is a phase II study. All patients are treatment naive extensive stage small cell lung cancer(ES-SCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of Ivonescimab and Cadonilimab in combination with chemotherapy in patients with ES-SCLC.

Key Dates

Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy
    Subjects receive Ivonescimab+Cadonilimab + Etoposide+Carboplatin for 4 cycles followed by Ivonescimab and Cadonilimab until progression.

Primary Outcome Measure

ORR [ Time Frame: Up to approximately 2 years ]

Central Contacts

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