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Purpose

This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A - Ivonescimab and chemotherapy 		Subject will receive ivonescimab and chemotherapy
  • Biological: Ivonescimab Injection
    Subject will receive ivonescimab and chemotherapy as an IV injection
Active Comparator
Arm B - Pembrolizumab and chemotherapy 		Subject will receive pembrolizumab and chemotherapy
  • Biological: Pembrolizumab Injection
    Subject will receive pembrolizumab and chemotherapy as an IV injection

Recruiting Locations

Clinical Study Site
Tucson 5318313, Arizona 5551752 85711

Clinical Study Site
Little Rock 4119403, Arkansas 4099753 72205

Clinical Study Site
Cerritos 5335663, California 5332921 90703

Clinical Study Site
Los Angeles 5368361, California 5332921 90033

Clinical Study Site
Los Angeles 5368361, California 5332921 90067

Clinical Study Site
Sacramento 5389489, California 5332921 95816

Clinical Study Site
Sacramento 5389489, California 5332921 95817

Clinical Study Site
Santa Monica 5393212, California 5332921 90404

Clinical Study Site
Santa Rosa 5393287, California 5332921 95403

Clinical Study Site
Lone Tree 5429208, Colorado 5417618 80124

Clinical Study Site
Hartford 4835797, Connecticut 4831725 06053

Clinical Study Site
Fort Myers 4155995, Florida 4155751 33901

Clinical Study Site
Jacksonville 4160021, Florida 4155751 32256

Clinical Study Site
Ocala 4166673, Florida 4155751 34474

Clinical Study Site
Palm Bay 4167499, Florida 4155751 32901

Clinical Study Site
Pembroke Pines 4168139, Florida 4155751 33028

Clinical Study Site
Pensacola 4168228, Florida 4155751 32503

Clinical Study Site
Petersburg, Florida 4155751 33709

Clinical Study Site
Plantation 4168782, Florida 4155751 33322

Clinical Study Site
St. Petersburg 4171563, Florida 4155751 33705

Clinical Study Site
West Palm Beach 4177887, Florida 4155751 33401

Clinical Study Site
Peoria 4905687, Illinois 4896861 61615

Clinical Study Site
Westwood 4281639, Kansas 4273857 66205

Clinical Study Site
Lexington 4297983, Kentucky 6254925 40503

Clinical Study Site
Baltimore 4347778, Maryland 4361885 21187

Clinical Study Site
Burlington 4931737, Massachusetts 6254926 01805

Clinical Study Site
Ann Arbor 4984247, Michigan 5001836 48109

Clinical Study Site
Detroit 4990729, Michigan 5001836 48202

Clinical Study Site
Saint Paul 5045360, Minnesota 5037779 55101

Clinical Study Site
Billings 5640350, Montana 5667009 59102

Clinical Study Site
New York 5128581, New York 5128638 10029

Clinical Study Site
New York 5128581, New York 5128638 10065

Clinical Study Site
Chapel Hill 4460162, North Carolina 4482348 27514

Clinical Study Site
Charlotte 4460243, North Carolina 4482348 28204

Clinical Study Site
Cincinnati 4508722, Ohio 5165418 45242

Clinical Study Site
Cleveland 5150529, Ohio 5165418 44106

Clinical Study Site
Cleveland 5150529, Ohio 5165418 44195

Clinical Study Site
Eugene 5725846, Oregon 5744337 97401

Clinical Study Site
Charleston 4574324, South Carolina 4597040 29425

Clinical Study Site
Greenville 4580543, South Carolina 4597040 29605

Clinical Study Site
Germantown 4624601, Tennessee 4662168 38138

Clinical Study Site
Nashville 4644585, Tennessee 4662168 37203

Clinical Study Site
Austin 4671654, Texas 4736286 78745

Clinical Study Site
Dallas 4684888, Texas 4736286 75246

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Jianjun Zhang, MD
713-563-6096
jzhang20@mdanderson.org

Clinical Study Site
San Antonio 4726206, Texas 4736286 78216

Clinical Study Site
Tyler 4738214, Texas 4736286 75702

Clinical Study Site
Norfolk 4776222, Virginia 6254928 23502

Clinical Study Site
Reston 4781530, Virginia 6254928 20190

Clinical Study Site
Seattle 5809844, Washington 5815135 98103

Clinical Study Site
Spokane 5811696, Washington 5815135 99202

Clinical Study Site
Madison 5261457, Wisconsin 5279468 53792

More Details

NCT ID
NCT05899608
Status
Recruiting
Sponsor
Summit Therapeutics

Study Contact

Summit Clinical Trial Information
1-833-256-0522
medicalinformation@smmttx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.