Trial Title:
Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
NCT ID:
NCT05899608
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Ivonescimab Injection
Description:
Subject will receive ivonescimab and chemotherapy as an IV injection
Arm group label:
Arm A - Ivonescimab and chemotherapy
Intervention type:
Biological
Intervention name:
Pembrolizumab Injection
Description:
Subject will receive pembrolizumab and chemotherapy as an IV injection
Arm group label:
Arm B - Pembrolizumab and chemotherapy
Summary:
This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined
with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line
Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is
overall survival and key secondary endpoints include progression free survival. response
and safety.
Criteria for eligibility:
Criteria:
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 NSCLC
- Tumor Proportion Score (TPS) with PD-L1 expression percent
- 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,
or non-squamous NSCLC histology.
- Known actionable genomic alterations in epidermal growth factor receptor (EGFR),
anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved
therapies are available
- Has received any prior therapy for NSCLC in the metastatic setting
- Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), or major
blood vessels (e.g aorta, central veins), if poses a significant increased risk of
bleeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Jacksonville
Zip:
32256
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Ocala
Zip:
34474
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Palm Bay
Zip:
32901
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Pensacola
Zip:
32503
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Plantation
Zip:
33322
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Burlington
Zip:
01085
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Saint Paul
Zip:
55101
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Billings
Zip:
59102
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Albany
Zip:
12206
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Harlingen
Zip:
78550
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jianjun Zhang, MD
Phone:
713-563-6096
Email:
jzhang20@mdanderson.org
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Webster
Zip:
77598
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Reston
Zip:
20190
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
London
Zip:
N6A5W9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Summit Therapeutics Research Center
Address:
City:
Regina
Zip:
S4T7T1
Country:
Canada
Status:
Recruiting
Start date:
October 26, 2023
Completion date:
December 20, 2027
Lead sponsor:
Agency:
Summit Therapeutics
Agency class:
Industry
Source:
Summit Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899608
