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NCT06712316 | RECRUITING | Non-small Cell Lung Cancer

Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Sponsor:

BioNTech SE

Brief Summary:

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.

Condition or disease

Non-small Cell Lung Cancer

Intervention/treatment

BNT327

Pembrolizumab

Carboplatin

Pemetrexed

Paclitaxel

Phase

PHASE2

PHASE3

Detailed Description:

Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of BNT327 plus chemotherapy for the Phase 2 part of each substudy. After the analysis of the Phase 2 data (efficacy, safety, and exposure-response), an internal review committee (IRC) will recommend whether participants will be treated with BNT327 at dose level 1 or 2 in the Phase 3 part of the substudies. After dose selection, the selected dose will be used for all participants in the study. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDCM will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants. The planned study duration per study participant is up to 64 months.

Study Type : INTERVENTIONAL
Estimated Enrollment : 982 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer
Actual Study Start Date : 2025-01-07
Estimated Primary Completion Date : 2029-12
Estimated Study Completion Date : 2030-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * Have 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, 8th edition without actionable epidermal growth factor receptor mutation or anaplastic lymphoma kinase (ALK) rearrangement.
  • * 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.
  • Key Exclusion Criteria
    • * Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic component.
    • * Have received any of the following therapies or drugs within the noted time intervals 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 chemotherapy and/or anti-PD(L)-1 as part of adjuvant or neoadjuvant treatment
      • * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 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 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 causing fistula/perforation.
      • * Participants with evidence of major coagulation disorders or other significant risks of hemorrhage.
      • * Have superior vena cava syndrome or symptoms of spinal cord compression.
      • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Location Details

NCT06712316

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Down

Alaska Oncology and Hematology, LLC

Anchorage, Alaska, United States, 99508

RECRUITING

United States, Florida

Clermont Oncology Center

Clermont, Florida, United States, 34711

RECRUITING

United States, Iowa

Physicians Clinic of Iowa

Cedar Rapids, Iowa, United States, 52401-2112

RECRUITING

United States, Kentucky

Baptist Health

Lexington, Kentucky, United States, 40503

RECRUITING

United States, Missouri

SSM Health Cancer Care - St. Clare

Fenton, Missouri, United States, 63026

RECRUITING

United States, New Jersey

ASSRACE CANCER which

East Brunswick, New Jersey, United States, 08816

RECRUITING

United States, New York

White Plains Hospital

White Plains, New York, United States, 10601

RECRUITING

United States, North Carolina

Fletcher Hospital, Inc. dba AdventHealth Hendersonville

Hendersonville, North Carolina, United States, 28792

RECRUITING

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

RECRUITING

United States, Tennessee

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Tennessee

Baptist Cancer Center

Memphis, Tennessee, United States, 38120

ACTIVE NOT RECRUITING

United States, Texas

Millennium Research and Clinical Development, LLC

Houston, Texas, United States, 77090

RECRUITING

Australia,

Cairns Hospital

Cairns, Australia, 4870

RECRUITING

Australia,

Dubbo Hospital

Dubbo, Australia, 2830

RECRUITING

Australia,

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Australia, 3199

RECRUITING

Australia,

Icon Cancer Centre Kurralta Park

Parking Park, Australia, 5037

RECRUITING

Australia,

Western Health Sunshine Hospital

St Albans, Australia, 3021

RECRUITING

Australia,

ICON Cancer Care - Townsville

Townsville, Australia, 4812

RECRUITING

Australia,

Cancer Care Wollongong Pty Limited

Wollongong, Australia, 2500

RECRUITING

China,

Shanghai Chest Hospital

Shanghai, China, 200030

RECRUITING

France,

Angers University Hospital Center (CHU Angers)

Angers, France, 49933

RECRUITING

France,

CHU Normandy Caen

Caen, France, 14033

RECRUITING

France,

Centre Francois Baclesse

Caen, France, 14076

RECRUITING

France,

West Cancerology Institute (ICO)- CLCC Rene Gauducheau

Saint-Herblain, France, 44805

RECRUITING

France,

Intercommunal Hospital Center Toulon La Seyne sur Mer (C.H.I.T.S) - Hospital Font -PRE

Toulon, France, 83000

RECRUITING

Germany,

Klinikum Esslingen GmbH

Esslingen, Germany, 73730

RECRUITING

Germany,

Lung specialist clinic Immenhausen - Pneumological teaching clinic of the University of Goettingen

Immmenhausen, Germany, 34376

RECRUITING

Italy,

San Giuseppe Moscati Hospital

Avellino, Italy, 83100

RECRUITING

Italy,

IRCCS Romagna Institute for the study of tumors Dino Amadori (IRST)

Meldola, Italy, 47014

RECRUITING

Italy,

Dr. Pederzoli Polyspecial Care House

Peschiera del Garda, Italy, 37019

RECRUITING

Italy,

Tiberina Isola Hospital Foundation - Isola Gemelli

Rome, Italy, 00186

RECRUITING

Korea, Republic of,

Chungbuk National University Hospital

Cheongju-Si, Korea, Republic of, 28644

RECRUITING

Korea, Republic of,

Chungnam National University Hospital (CNUH)

Daejeon, Korea, Republic of, 35015

RECRUITING

Korea, Republic of,

National Cancer Center

Shaky, Korea, Republic of, 10408

RECRUITING

Korea, Republic of,

Gachon University Gil Medical Center

Incheon, Korea, Republic of, 21565

RECRUITING

Korea, Republic of,

Gyeongsang National University Hospital (GNUH)

jin大发-公司, Korea, Republic of, 52727

RECRUITING

Korea, Republic of,

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Asan Medical Center (AMC)

Seoul, Korea, Republic of, 05505

RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of, 06351

RECRUITING

Korea, Republic of,

Korea University Teacher Hospital

Seoul, Korea, Republic of, 08308

RECRUITING

Korea, Republic of,

The Catholic University Of Korea, St. Vincent's Hospital

Slop, Korea, Republic of, 16247

RECRUITING

Korea, Republic of,

University Hospital upgrade

Slop, Korea, Republic of, 16499

RECRUITING

Poland,

NZOZ Medpolonia Sp. Z o.o.

Poznan, Poland, 60-693

RECRUITING

Poland,

Voivodship Hospital Saint Father Pio in Przemysl

Industry, Poland, 37-700

RECRUITING

Poland,

Instytut MSF SP. Z O.O.

Łódź, Poland, 90-302

RECRUITING

Romania,

Cardiomed

Cluj-Napoca, Romania, 400015

RECRUITING

Romania,

SC MEDISPROF S.R.L, medical oncology

Cluj-Napoca, Romania, 400641

RECRUITING

Romania,

Radiotherapy Center Cluj

Cluj, Romania, 407280

RECRUITING

Romania,

ONCO CLINIC CONSULT SA

Craiova, Romania, 200094

RECRUITING

Romania,

Oncomed

Timisoara, Romania, 300239

RECRUITING

Spain,

Virgen del Rocio University Hospital

Seville, Spain, 41013

RECRUITING

Turkey,

Adana City Training and Research Hospital

Adana, Turkey, 1370

RECRUITING

Turkey,

Gulhane Training and Research Hospital

Ankara, Turkey, 06010

RECRUITING

Turkey,

Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey, 06200

RECRUITING

Turkey,

Hacettepe University Medicine Faculty

Ankara, Turkey, 06230

RECRUITING

Turkey,

Memorial Ankara Hospital

Ankara, Turkey, 06520

RECRUITING

Turkey,

Liv Hospital Ankara

Ankara, Turkey, 06680

RECRUITING

Turkey,

Ankara Bilkent City Hospital

Ankara, Turkey, 06800

RECRUITING

Turkey,

Akdeniz University Hospital

Antalya, Turkey, 7985

RECRUITING

Turkey,

Gaziantep Sanko University Medical Faculty

Gaziantep, Turkey, 36020

RECRUITING

Turkey,

Bezmialem Foundation University Medical Faculty

Istanbul, Turkey, 34093

RECRUITING

Turkey,

Yeditepe University Kosuyolu Hospital

Istanbul, Turkey, 34718

RECRUITING

Turkey,

Medical Point Izmir Hospital

İzmir, Turkey, 35325

RECRUITING

Turkey,

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadikoy, Turkey, 34722

RECRUITING

Turkey,

Kocaeli University Type Faculty

Kocaeli, Turkey, 41380

RECRUITING

Turkey,

Medical Park Florya Hospital

Kucukcekmece, Turkey, 34295

RECRUITING

Turkey,

Sakarya University - Faculty of Medicine

Sakarya, Turkey, 54290

RECRUITING

Turkey,

Ondokuz Mayis University Health Practice and Research Hospital

Samsun, Turkey, 55280

RECRUITING

Turkey,

Acibadem Adana Hospital

Seyhan, Turkey, 01130

RECRUITING

Turkey,

Medical Park Seyhan Hospital

Seyhan, Turkey, 01170

RECRUITING

Turkey,

Gazi University Faculty of Medicine

Yenimahalle, Turkey, 06560

RECRUITING

Turkey,

Koc University Hospital (Koc University Hospital)

Zeytinburnu, Turkey, 34010

RECRUITING

United Kingdom,

Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom, BN2 5BE

RECRUITING

United Kingdom,

Velindre NHS Trust, Velindre Cancer Center

Cardiff, United Kingdom, CF14 2TL

RECRUITING

United Kingdom,

Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom, Hu16 5JQ

RECRUITING

United Kingdom,

University College Hospital

London, United Kingdom, NW2 1PG

RECRUITING

United Kingdom,

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

RECRUITING

United Kingdom,

Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals

Oxford, United Kingdom, Slag

RECRUITING

United Kingdom,

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom, Lightning of health

RECRUITING

United Kingdom,

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

RECRUITING

United Kingdom,

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP