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The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
The main questions the study aims to answer are:
Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivonescimab + AK117 + Chemotherapy | Experimental |
| |
| Ivonescimab + Cadonilimab + Chemotherapy | Experimental |
| |
| Ivonescimab + Chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivonescimab | Drug | Administered intravenously at a specified dose and frequency. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The proportion of participants achieving a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to approximately 2 years. |
| Incidence of Adverse Events (AEs) | The number and percentage of participants experiencing any Adverse Event (AE). An AE is defined as any untoward medical occurrence in a participant administered a study drug, which may not have a causal relationship with the treatment. Severity will be graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. | From first dose up to 90 days after last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | The proportion of participants achieving a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator per RECIST v1.1. | Up to approximately 2 years. |
| Duration of Response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li | Contact | +86-18116403289 | wenting01.li@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100020 | 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 | Administered intravenously at a specified dose and frequency. |
|
| AK117 | Drug | Administered intravenously at a specified dose and frequency. |
|
| Etoposide | Drug | Administered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles. |
|
| Carboplatin (AUC 5) | Drug | Administered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles. |
|
For responders (participants achieving CR or PR), DoR is defined as the time from the first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.
| Up to approximately 2 years. |
| Time to Response (TTR) | For responders (participants achieving CR or PR), TTR is defined as the time from the start of study treatment to the first documented objective response (CR or PR), per RECIST v1.1. | Up to approximately 2 years. |
| Progression-Free Survival (PFS) | PFS is defined as the time from the start of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. | Up to approximately 2 years. |
| Overall Survival (OS) | OS is defined as the time from the start of study treatment to death from any cause. | Up to approximately 5 years. |
| Serum concentrations of Ivonescimab, Cadonilimab, and AK117 | Serum concentrations of Ivonescimab, Cadonilimab, and AK117 will be measured to characterize the pharmacokinetic (PK) profiles. | Up to approximately 2 years. |
| Incidence of Anti-drug Antibodies (ADA) | The immunogenicity will be assessed by the incidence of participants who develop detectable anti-drug antibodies (ADA) against Ivonescimab, Cadonilimab, and/or AK117. | Up to approximately 2 years. |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710000 | China |
|
| Shanghai Pulmonary Hospital Affiliated to Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| 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 |