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

Last updated: May 15, 2025
Sponsor: BioNTech SE
Overall Status: Active - Recruiting

Phase

2/3

Condition

Non-small Cell Lung Cancer

Treatment

Pemetrexed

Paclitaxel

BNT327

Clinical Study ID

NCT06712316
BNT327-06
2024-515764-31-00
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 982
Treatment Group(s): 5
Primary Treatment: Pemetrexed
Phase: 2/3
Study Start date:
January 07, 2025
Estimated Completion Date:
December 31, 2030

Study 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 decide 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 parts of both substudies, an independent data monitoring committee (IDMC) will be established as needed to provide independent review of the data during the study.

The sponsor may decide not to perform or stop recruiting participants in the Phase 2 part of the study depending on data generated in the BNT327-01 (NCT06449209) and BNT327-02 (NCT06449222) studies. The sponsor may also choose not to continue all substudies.

Connect with a study center

  • Cairns Hospital

    Cairns, 4870
    Australia

    Active - Recruiting

  • Dubbo Hospital

    Dubbo, 2830
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, 3199
    Australia

    Active - Recruiting

  • ICON Cancer Care - Townsville

    Hyde Park, 4812
    Australia

    Site Not Available

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037
    Australia

    Active - Recruiting

  • Western Health Sunshine Hospital

    St Albans, 3021
    Australia

    Active - Recruiting

  • ICON Cancer Care - Townsville

    Townsville, 4812
    Australia

    Active - Recruiting

  • Cancer Care Wollongong Pty Limited

    Wollongong, 2500
    Australia

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital (CNUH)

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital (GNUH)

    Jinju-si, 52727
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon-si, 16499
    Korea, Republic of

    Active - Recruiting

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

    Suwon-si, 16247
    Korea, Republic of

    Active - Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Hacettepe University Medicine Faculty

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Liv Hospital Ankara

    Ankara, 06680
    Turkey

    Active - Recruiting

  • Memorial Ankara Hospital

    Ankara, 06520
    Turkey

    Active - Recruiting

  • Gaziantep Sanko University Medical Faculty

    Gaziantep, 36020
    Turkey

    Active - Recruiting

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093
    Turkey

    Active - Recruiting

  • Yeditepe University Kosuyolu Hospital

    Istanbul, 34718
    Turkey

    Active - Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy, 34722
    Turkey

    Active - Recruiting

  • Gulhane Training and Research Hospital

    Kecioren, 06010
    Turkey

    Active - Recruiting

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Medical Park Florya Hospital

    Kucukcekmece, 34295
    Turkey

    Active - Recruiting

  • Sakarya University - Faculty of Medicine

    Sakarya, 54290
    Turkey

    Active - Recruiting

  • Ondokuz Mayis University Health Practice and Research Hospital

    Samsun, 55280
    Turkey

    Active - Recruiting

  • Acibadem Adana Hospital

    Seyhan, 01130
    Turkey

    Active - Recruiting

  • Medical Park Seyhan Hospital

    Seyhan, 01170
    Turkey

    Active - Recruiting

  • Gazi University Faculty of Medicine

    Yenimahalle, 06560
    Turkey

    Active - Recruiting

  • Memorial Ankara Hospital

    Çankaya, 06520
    Turkey

    Site Not Available

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL
    United Kingdom

    Active - Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, HU16 5JQ
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, NW2 1PG
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

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

    Oxford, OX3 7LJ
    United Kingdom

    Active - Recruiting

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT
    United Kingdom

    Active - Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • Alaska Oncology and Hematology, LLC

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Clermont Oncology Center

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa 52401-2112
    United States

    Active - Recruiting

  • SSM Health Cancer Care - St. Clare

    Fenton, Missouri 63026
    United States

    Active - Recruiting

  • Fletcher Hospital, Inc. dba AdventHealth Hendersonville

    Hendersonville, North Carolina 28792
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Millennium Research and Clinical Development, LLC

    Houston, Texas 77090
    United States

    Active - Recruiting

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