Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrECOG, LLC.
About this trial
Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide.
Ivonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.
Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.
Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.
The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
No prior systemic therapy for the disease under study (ES-SCLC).
Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Patient must be ≥ 18 years of age.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Ivonescimab 10 mg/kg
DrugInduction every 21 days x 4 cycles: Ivonescimab 10 mg/kg intravenous (IV) on Day 1 followed by carboplatin area under the curve (AUC) 5 IV on Day 1 and etoposide 100 milligrams per square meter (mg/m²) IV on Day 1, 2 and 3 followed by maintenance ivonescimab 10 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction.
Ivonescimab 20 mg/kg
DrugInduction every 21 days x 4 cycles: Ivonescimab 20 mg/kg IV on Day 1 followed by carboplatin AUC 5 IV on Day 1 and etoposide 100 mg/m² IV on Day 1, 2 and 3 followed by maintenance ivonescimab 20 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Arm A: Ivonescimab 10 mg/kgExperimental treatment 1 intervention
Group B: Arm B: Ivonescimab 20 mg/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Overall Response Rate (ORR)
Overall Response Rate (ORR) defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria at each dose level.
Time frame
18 months2
Optimal Dose of Ivonescimab in Combination with Carboplatin and Etoposide - Grade 3-5 Treatment-Related Toxicity Rate
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE V5.0) that are not resolved in accordance with treatment guidelines will be counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Time frame
18 monthsSecondary outcomes
1
Progression-Free Survival (PFS) of Ivonescimab in Combination with Carboplatin and Etoposide
PFS based on the Kaplan-Meier method defined as the duration between randomization and documented disease progression (PD) defined per RECIST 1.1 criteria. or death, or is censored at time of last disease assessment.
Time frame
18 months2
Overall Survival (OS) of of Ivonescimab in Combination with Carboplatin and Etoposide
OS based on the Kaplan-Meier method defined as the time from study entry to death or censored at date last known alive.
Time frame
24 months3
Disease Control Rate (DCR) of Ivonescimab in Combination with Carboplatin and Etoposide
DCR defined as the proportion of participants who achieved a best overall response of complete response (CR), partial response (PR) , or stable disease (SD), as determined by investigator assessment (disease control rate- CR+PR+SD) per RECIST v1.1. Patients who have not progressed by the time of analysis will be censored at the date they are last known to be alive and progression-free.
Time frame
18 months4
Duration of Response (DoR) of Ivonescimab in Combination with Carboplatin and Etoposide
DoR is defined as from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients who have not progressed by the time of analysis will be censored at the date they are last known to be alive and progression-free.
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
PrECOG, LLC.
Lead sponsor
Summit Therapeutics
Collaborator
Source ClinicalTrials.gov