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

Phase 2

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Ivonescimab; Drug: Cadonilimab; Drug: Etoposide; Drug: Carboplatin

• Registration Number: NCT06769971
• Lead Sponsor: Sichuan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.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；

Exclusion Criteria

1. Active malignancies within the past 5 years, with the exception of tumors in this study and cured local tumors；
2. Received palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose；
3. Subjects who received any prior treatments targeting the mechanism of tumor immunity；
4. Subjects who received any prior anti-angiogenic therapy；
5. Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels；
6. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment；
7. Symptomatic metastases of the central nervous system；
8. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage；
9. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months before the first study drug administration；
10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
12. Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection that has received systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C)；
13. Concurrent enrollment in another clinical study, unless it is a noninterventional clinical study or the follow-up period of the interventional study is more than 4 weeks from the last dose of the prior clinical study or more than 5 half-lives of the prior study drug, whichever is shorter.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ORR	Up to approximately 2 years
Safety	Up to approximately 2 years	Grade 3-4 AEs

Secondary Outcome Measures

Name	Time	Method
OS	Up to approximately 2 years
TTR	Up to approximately 2 years
PFS	Up to approximately 2 years
DCR	Up to approximately 2 years
DOR	Up to approximately 2 years

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China