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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy | Experimental | Subjects receive Ivonescimab+Cadonilimab + Etoposide+Carboplatin for 4 cycles followed by Ivonescimab and Cadonilimab until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivonescimab | Drug | 20mg/kg,IV infusion,Day1,Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Up to approximately 2 years | |
| Safety | Grade 3-4 AEs | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Up to approximately 2 years | |
| DOR | Up to approximately 2 years | |
| TTR |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ge Gao, PhD | Contact | 86(028)85421606 | gg1023@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongsheng Wang, Prof | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D005047 | Etoposide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| 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 |
|
| Up to approximately 2 years |
| PFS | Up to approximately 2 years |
| OS | Up to approximately 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |