Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Recruiting · NCT06712316 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 18 US states.
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology - Birmingham, Alabama, United States
- Alaska Oncology and Hematology, LLC - Anchorage, Alaska, United States
- John Muir Clinical Research Center - Concord, California, United States
- University Of California - San Diego Moores Cancer Center - La Jolla, California, United States
- Clermont Oncology Center - Clermont, Florida, United States
- Mid Florida Cancer Centers - Orange City, Florida, United States
- Cleveland Clinic Florida - Martin North Hospital - Stuart, Florida, United States
- H. Lee Moffit Cancer center and research institute - Tampa, Florida, United States
- Cleveland Clinic Weston Hospital - Weston, Florida, United States
- Fort Wayne Medical Oncology and Hematology, Inc. - Fort Wayne, Indiana, United States
- Physicians Clinic of Iowa - Cedar Rapids, Iowa, United States
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics - Iowa City, Iowa, United States
- Baptist Health Hardin - Elizabethtown, Kentucky, United States
- Frederick Health Hospital- James M Stockman Cancer Institute - Frederick, Maryland, United States
- Missouri Cancer Associates - Columbia, Missouri, United States
- SSM Health Cancer Care - St. Clare - Fenton, Missouri, United States
- Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) - Hastings, Nebraska, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States
- Summit Medical Group PA - Florham Park, New Jersey, United States
- The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion - Paramus, New Jersey, United States
- Suny-Stony Brook University Cancer Center - Stony Brook, New York, United States
- White Plains Hospital - White Plains, New York, United States
- Fletcher Hospital, Inc. dba AdventHealth Hendersonville - Hendersonville, North Carolina, United States
- Gabrail Cancer Center Research - Canton, Ohio, United States
- The Christ Hospital Cancer Center - Cincinnati, Ohio, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Dayton Physicians Network - Dayton, Ohio, United States
- Kettering Medical Center - Kettering, Ohio, United States
- Cleveland Clinic - Hillcrest Hospital - Mayfield Heights, Ohio, United States
- INTEGRIS Cancer Institute of Oklahoma - Oklahoma City, Oklahoma, United States
- University of Tennessee Medical Center - Knoxville, Tennessee, United States
- Baptist Cancer Center - Memphis, Tennessee, United States
- Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Millennium Research and Clinical Development, LLC - Houston, Texas, United States
- Virginia Cancer Specialists - Arlington - Arlington, Virginia, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- VCU Massey Cancer Center - Richmond, Virginia, United States
- Shenandoah Oncology - Winchester, Virginia, United States
- CHUAC Hospital Teresa Herrera - A Coruña, Spain
- Uniklinik RWTH Aachen Medizinische Klinik IV - Aachen, Germany
- Baskent Universitesi Tip Fakultesi Adana Hastanesi - Adana, Turkey (Türkiye)
- Adana City Training and Research Hospital - Adana, Turkey (Türkiye)
- Cancer Research SA (CRSA) - Adelaide, Australia
- Royal Adelaide Hospital - Adelaide, Australia
- Ageo Central General Hospital - Ageo, Japan
- Hyogo Cancer Center - Akashi, Japan
- Institut de Cancerologie de l'Ouest Paul Papin - Angers, France
- Centre Hospitalier Universitaire d'Angers (CHU Angers) - Angers, France
- Gulhane Training and Research Hospital - Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital - Ankara, Turkey (Türkiye)
- Hacettepe University Medicine Faculty - Ankara, Turkey (Türkiye)
- Memorial Ankara Hospital - Ankara, Turkey (Türkiye)
- Liv Hospital Ankara - Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital - Ankara, Turkey (Türkiye)
- Akdeniz University Hospital - Antalya, Turkey (Türkiye)
- Azienda Ospedaliera San Giuseppe Moscati - Avellino, Italy
- Centro di Riferimento Oncologico - Aviano, Italy
- Hospital Universitario de Badajoz - Badajoz, Spain
Showing 60 of 262 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →