Phase
Condition
Non-small Cell Lung Cancer
Treatment
Pemetrexed
Paclitaxel
BNT327
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Have histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (whoare not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per theUnion Internationale contre le Cancer/American Joint Committee on Cancer stagingsystem, 8th edition without actionable EGFR mutation or anaplastic lymphoma kinaserearrangement.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.Lesions treated after prior local treatment (radiotherapy, ablation, interventionalprocedures, etc.) are generally not considered as target lesions. If the lesion withprior local treatment is the only targeted lesion, evidence-based radiology must beprovided to demonstrate disease progression (the single bone metastasis or thesingle central nervous system metastasis should not be considered as a measurablelesion).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function.
Exclusion
Key Exclusion Criteria:
Have histologically or cytologically confirmed NSCLC with small-cell lung cancerhistologic component.
Have received any of the following therapies or drugs within the noted timeintervals prior to study treatment:
Participants who received prior treatment with anti-VEGF monoclonal antibody,or PD(L)-1/VEGF bispecific antibody or received platinum-based chemotherapyand/or anti-PD(L)-1 as part of adjuvant or neoadjuvant treatment
Have received systemic corticosteroids (at a dosage greater than 10 mg/day ofprednisone or an equivalent dose of other corticosteroids) within 14 days priorto the initiation of study treatment. Note: local, intranasal, intraocular,intra-articular or inhaled corticosteroids, short-term use (≤7 days) ofcorticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) ortreatment of non-autoimmune conditions (e.g., delayed hypersensitivityreactions caused by exposure to allergens) are allowed.
Have uncontrolled hypertension or poorly controlled diabetic conditions prior tostudy treatment.
Have a serious non-healing wound, ulcer, or 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.In addition, the participant must have undergone correction (or spontaneous healing)of the perforation/fistula and/or the underlying process causingfistula/perforation.
Participants with evidence of major coagulation disorders or other significant risksof hemorrhage.
Have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Cairns Hospital
Cairns, 4870
AustraliaActive - Recruiting
Dubbo Hospital
Dubbo, 2830
AustraliaActive - Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, 3199
AustraliaActive - Recruiting
ICON Cancer Care - Townsville
Hyde Park, 4812
AustraliaSite Not Available
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
AustraliaActive - Recruiting
Western Health Sunshine Hospital
St Albans, 3021
AustraliaActive - Recruiting
ICON Cancer Care - Townsville
Townsville, 4812
AustraliaActive - Recruiting
Cancer Care Wollongong Pty Limited
Wollongong, 2500
AustraliaActive - Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
Korea, Republic ofActive - Recruiting
Chungnam National University Hospital (CNUH)
Daejeon, 35015
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang-si, 10408
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofActive - Recruiting
Gyeongsang National University Hospital (GNUH)
Jinju-si, 52727
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon-si, 16499
Korea, Republic ofActive - Recruiting
The Catholic University Of Korea, St. Vincent's Hospital
Suwon-si, 16247
Korea, Republic ofActive - Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
TurkeyActive - Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200
TurkeyActive - Recruiting
Hacettepe University Medicine Faculty
Ankara, 06230
TurkeyActive - Recruiting
Liv Hospital Ankara
Ankara, 06680
TurkeyActive - Recruiting
Memorial Ankara Hospital
Ankara, 06520
TurkeyActive - Recruiting
Gaziantep Sanko University Medical Faculty
Gaziantep, 36020
TurkeyActive - Recruiting
Bezmialem Foundation University Medical Faculty
Istanbul, 34093
TurkeyActive - Recruiting
Yeditepe University Kosuyolu Hospital
Istanbul, 34718
TurkeyActive - Recruiting
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, 34722
TurkeyActive - Recruiting
Gulhane Training and Research Hospital
Kecioren, 06010
TurkeyActive - Recruiting
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
TurkeyActive - Recruiting
Medical Park Florya Hospital
Kucukcekmece, 34295
TurkeyActive - Recruiting
Sakarya University - Faculty of Medicine
Sakarya, 54290
TurkeyActive - Recruiting
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, 55280
TurkeyActive - Recruiting
Acibadem Adana Hospital
Seyhan, 01130
TurkeyActive - Recruiting
Medical Park Seyhan Hospital
Seyhan, 01170
TurkeyActive - Recruiting
Gazi University Faculty of Medicine
Yenimahalle, 06560
TurkeyActive - Recruiting
Memorial Ankara Hospital
Çankaya, 06520
TurkeySite Not Available
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, CF14 2TL
United KingdomActive - Recruiting
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ
United KingdomActive - Recruiting
University College Hospital
London, NW2 1PG
United KingdomActive - Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
United KingdomActive - Recruiting
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
Oxford, OX3 7LJ
United KingdomActive - Recruiting
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
United KingdomActive - Recruiting
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT
United KingdomActive - Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
United KingdomActive - Recruiting
Alaska Oncology and Hematology, LLC
Anchorage, Alaska 99508
United StatesActive - Recruiting
Clermont Oncology Center
Clermont, Florida 34711
United StatesActive - Recruiting
Physicians Clinic of Iowa
Cedar Rapids, Iowa 52401-2112
United StatesActive - Recruiting
SSM Health Cancer Care - St. Clare
Fenton, Missouri 63026
United StatesActive - Recruiting
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville, North Carolina 28792
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Millennium Research and Clinical Development, LLC
Houston, Texas 77090
United StatesActive - Recruiting
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