This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate organ function as defined in the protocol.
Key Exclusion Criteria:
* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
* Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
* Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
* Participants with significant risk of hemorrhage (per investigator clinical judgment).
* Participants have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs — From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) — From the first dose of IMP to the 90-day Follow-Up Visit For substudies A and B.
Phase 2 - Objective response rate (ORR) — Up to approximately 2 years For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
Phase 2 - Best percentage change from baseline in tumor size — Up to approximately 2 years For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1.
Phase 3 - Progression free survival (PFS) assessed by BICR — Up to approximately 5 years For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Trial sites (262)
Facility
City
Region
Status
Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
Birmingham
Alabama
Recruiting
Alaska Oncology and Hematology, LLC
Anchorage
Alaska
Recruiting
John Muir Clinical Research Center
Concord
California
Recruiting
University Of California - San Diego Moores Cancer Center
La Jolla
California
Recruiting
Clermont Oncology Center
Clermont
Florida
Recruiting
Mid Florida Cancer Centers
Orange City
Florida
Recruiting
Cleveland Clinic Florida - Martin North Hospital
Stuart
Florida
Recruiting
H. Lee Moffit Cancer center and research institute
Tampa
Florida
Recruiting
Cleveland Clinic Weston Hospital
Weston
Florida
Recruiting
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne
Indiana
Recruiting
Physicians Clinic of Iowa
Cedar Rapids
Iowa
Recruiting
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City
Iowa
Recruiting
Baptist Health Hardin
Elizabethtown
Kentucky
Recruiting
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick
Maryland
Recruiting
Missouri Cancer Associates
Columbia
Missouri
Recruiting
SSM Health Cancer Care - St. Clare
Fenton
Missouri
Recruiting
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
Hastings
Nebraska
Recruiting
Astera Cancer Care
East Brunswick
New Jersey
Recruiting
Summit Medical Group PA
Florham Park
New Jersey
Recruiting
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Paramus
New Jersey
Recruiting
Suny-Stony Brook University Cancer Center
Stony Brook
New York
Recruiting
White Plains Hospital
White Plains
New York
Recruiting
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville
North Carolina
Recruiting
Gabrail Cancer Center Research
Canton
Ohio
Recruiting
The Christ Hospital Cancer Center
Cincinnati
Ohio
Recruiting
University of Cincinnati Medical Center
Cincinnati
Ohio
Recruiting
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
Cleveland
Ohio
Recruiting
Cleveland Clinic
Cleveland
Ohio
Recruiting
Dayton Physicians Network
Dayton
Ohio
Recruiting
Kettering Medical Center
Kettering
Ohio
Recruiting
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights
Ohio
Recruiting
INTEGRIS Cancer Institute of Oklahoma
Oklahoma City
Oklahoma
Recruiting
University of Tennessee Medical Center
Knoxville
Tennessee
Recruiting
Baptist Cancer Center
Memphis
Tennessee
Withdrawn
Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
Nashville
Tennessee
Recruiting
Millennium Research and Clinical Development, LLC
Houston
Texas
Active Not Recruiting
Virginia Cancer Specialists - Arlington
Arlington
Virginia
Recruiting
Virginia Cancer Specialists
Fairfax
Virginia
Recruiting
VCU Massey Cancer Center
Richmond
Virginia
Recruiting
Shenandoah Oncology
Winchester
Virginia
Recruiting
+ 222 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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