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A Randomized, Double-Blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy For The First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
Cancer Categories
Lung
Karmanos Trial ID
2024-101
NCT ID
NCT05899608
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Dipesh
Uprety, M.D.
Oncology - Medical
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Objective:
Primary Objectives:
To compare OS between ivonescimab combined with platinum-doublet chemotherapy and pembrolizumab combined with platinum-doublet chemotherapy
To compare investigator assessed progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 between ivonescimab combined with platinum-doublet chemotherapy and pembrolizumab combined with platinum- doublet chemotherapy
Secondary Objectives:
To compare the objective response rate (ORR), disease control rate (DCR), and duration of response (DoR) between ivonescimab combined with platinum-doublet chemotherapy versus pembrolizumab combined with platinum-doublet chemotherapy, as assessed by investigator, based on RECIST v1.1
To evaluate the safety and tolerability of ivonescimab in combination with platinumdoublet chemotherapy and compare to pembrolizumab combined with platinum-doublet chemotherapy
To evaluate the pharmacokinetic profile of ivonescimab in combination with platinumdoublet chemotherapy
To evaluate the immunogenicity of ivonescimab
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Age ≥ 18 years old at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Expected life expectancy ≥ 3 months
Metastatic (Stage IV) NSCLC
Histologically or cytologically confirmed squamous or non-squamous NSCLC
Recorded measurement of the Tumor Proportion Score (TPS) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
At least one measurable noncerebral lesion according to RECIST 1.1
No prior systemic treatment for metastatic NSCLC
Exclusion Criteria:
Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.
For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
Has received any prior therapy for NSCLC in the metastatic setting
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Lung
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Chemotherapy, Immunotherapy
Drugs
Carboplatin; Ivonescimab; Nab-paclitaxel; Pembrolizumab; Pemetrexed; paclitaxel
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