Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
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
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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 - Tumor Proportion Score (TPS) with 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A - Ivonescimab and chemotherapy |
Subject will receive ivonescimab and chemotherapy |
|
|
Active Comparator Arm B - Pembrolizumab and chemotherapy |
Subject will receive pembrolizumab and chemotherapy |
|
Recruiting Locations
Summit Therapeutics Research Center
Tucson, Arizona 85711
Tucson, Arizona 85711
Summit Therapeutics Research Center
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Summit Therapeutics Research Center
Los Angeles, California 90033
Los Angeles, California 90033
Summit Therapeutics Research Center
Los Angeles, California 90067
Los Angeles, California 90067
Summit Therapeutics Research Center
Sacramento, California 95817
Sacramento, California 95817
Summit Therapeutics Research Center
Santa Monica, California 90404
Santa Monica, California 90404
Summit Therapeutics Research Center
Santa Rosa, California 95403
Santa Rosa, California 95403
Summit Therapeutics Research Center
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Summit Therapeutics Research Center
Fort Myers, Florida 33901
Fort Myers, Florida 33901
Summit Therapeutics Research Center
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Summit Therapeutics Research Center
Ocala, Florida 34474
Ocala, Florida 34474
Summit Therapeutics Research Center
Palm Bay, Florida 32901
Palm Bay, Florida 32901
Summit Therapeutics Research Center
Pensacola, Florida 32503
Pensacola, Florida 32503
Summit Therapeutics Research Center
Plantation, Florida 33322
Plantation, Florida 33322
Summit Therapeutics Research Center
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Summit Therapeutics Research Center
Saint Petersburg, Florida 33709
Saint Petersburg, Florida 33709
Summit Therapeutics Research Center
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Summit Therapeutics Research Center
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Summit Therapeutics Research Center
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Summit Therapeutics Research Center
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Summit Therapeutics Research Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Summit Therapeutics Research Center
Detroit, Michigan 48202
Detroit, Michigan 48202
Summit Therapeutics Research Center
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Summit Therapeutics Research Center
Billings, Montana 59102
Billings, Montana 59102
Summit Therapeutics Research Center
New York, New York 10029
New York, New York 10029
Summit Therapeutics Research Center
New York, New York 10065
New York, New York 10065
Summit Therapeutics Research Center
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Summit Therapeutics Research Center
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Summit Therapeutics Research Center
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
Summit Therapeutics Research Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Summit Therapeutics Research Center
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Summit Therapeutics Research Center
Eugene, Oregon 97401
Eugene, Oregon 97401
Summit Therapeutics Research Center
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Summit Therapeutics Research Center
Austin, Texas 78745
Austin, Texas 78745
Summit Therapeutics Research Center
Dallas, Texas 75246
Dallas, Texas 75246
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Summit Therapeutics Research Center
Tyler, Texas 75702
Tyler, Texas 75702
Summit Therapeutics Research Center
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Summit Therapeutics Research Center
Reston, Virginia 20190
Reston, Virginia 20190
Summit Therapeutics Research Center
Spokane, Washington 99202
Spokane, Washington 99202
Summit Therapeutics Research Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT05899608
- Status
- Recruiting
- Sponsor
- Summit Therapeutics