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

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

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

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices