A Study of Ivonescimab in First-Line ES-SCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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:
* What side effects do participants experience from these combination treatments? * How well do the treatments work to shrink tumors?
Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are:
* Group 1 will also receive an additional drug called AK117. * Group 2 will also receive a different additional drug called Cadonilimab. * Group 3 will receive Ivonescimab and chemotherapy only.
Participants will:
* Be assigned by chance to one of the three groups. * Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group. * If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as defined by RECIST v1.1.
Age 18 to 75 years.
Disqualifiers
Active or untreated central nervous system (CNS) metastases (Treated, stable brain metastases are allowed).
History of severe hypersensitivity to monoclonal antibodies.
Active autoimmune disease requiring systemic treatment within the past 2 years.
Significant cardiovascular disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Ivonescimab
DrugAdministered intravenously at a specified dose and frequency.
Cadonilimab
DrugAdministered intravenously at a specified dose and frequency.
AK117
DrugAdministered intravenously at a specified dose and frequency.
Etoposide
DrugAdministered intravenously at 100 mg/m² on Days 1-3 of each 3-week cycle for 4 cycles.
Carboplatin (AUC 5)
DrugAdministered intravenously at AUC 5 on Day 1 of each 3-week cycle for 4 cycles.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Ivonescimab + AK117 + ChemotherapyExperimental treatment 4 interventions
Group B: Ivonescimab + Cadonilimab + ChemotherapyExperimental treatment 4 interventions
Group C: Ivonescimab + ChemotherapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 2 years.2
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.
Time frame
From first dose up to 90 days after last dose.Secondary outcomes
1
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.
Time frame
Up to approximately 2 years.2
Duration of Response (DoR)
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.
Time frame
Up to approximately 2 years.3
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.
Time frame
Up to approximately 2 years.4
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.
Time frame
Up to approximately 2 years. Source ClinicalTrials.gov