Phase II Study of Ivonescimab (PD1/VEGF Bispecific) and Cadonilimab(PDL1/CTLA4 Bispecific)in Combination with Etoposide and Carboplatin As First-line Therapy in Patients with Extensive Stage Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed; 2.18 to 75 years old (at the time of inform consent obtained); 3.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4.Have a life expectancy of at least 3 months; 5.Have histologically- or cytologically-confirmed diagnosis of Extensive Stage SCLC; 6.Had not received previous systemic therapy; Or ES-SCLC patients who had received definitive chemoradiotherapy for limited-stage small-cell lung cancer but had disease progression \> 6 months earlier; 7.Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator; 8.Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy; 9.Have adequate organ function; 10.All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment;

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Ge Gao, PhD
gg1023@foxmail.com
86(028)85421606
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Treatments
Experimental: ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy
Subjects receive Ivonescimab+Cadonilimab + Etoposide+Carboplatin for 4 cycles followed by Ivonescimab and Cadonilimab until progression.
Sponsors
Leads: Sichuan University

This content was sourced from clinicaltrials.gov

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