Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT ID: NCT05142189
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
280 participants
INTERVENTIONAL
2022-06-17
2031-11-30
Brief Summary
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The trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.
The trial will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, and resectable NSCLC of Stage II and III in Cohort 6.
Detailed Description
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* Cohorts 1 to 4, and Cohorts 7 to 10: 24 months
* Cohorts 5 and 11: 18 cycles, i.e., 12 months
* Cohort 6: 4 cycles of neo-adjuvant treatment and 18 cycles of adjuvant treatment, i.e., 12 months of adjuvant treatment
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT)
Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT.
BNT116
Intravenous injection
Bispecific antibody for PD-L1 and VEGF-A
Intravenous infusion
Cohort 1A - BNT116 Monotherapy
BNT116
Intravenous injection
Cohort 1B - BNT116 Monotherapy
BNT116
Intravenous injection
Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants)
BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Cohort 3 - BNT116 + Docetaxel
BNT116
Intravenous injection
Docetaxel
Intravenous infusion
Cohort 4 - BNT116 + Cemiplimab (Frail Participants)
BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT])
BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel
BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab
BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
Cohort 7 - BNT116 + BNT316
Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316
BNT116
Intravenous injection
BNT316
Intravenous infusion
Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor
Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor
BNT116
Intravenous injection
anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor
Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor
BNT116
Intravenous injection
anti-HER3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants)
Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established.
BNT116
Intravenous injection
Bispecific antibody for PD-L1 and VEGF-A
Intravenous infusion
Interventions
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BNT116
Intravenous injection
Cemiplimab
Intravenous infusion
Docetaxel
Intravenous infusion
Carboplatin
Intravenous infusion
Paclitaxel
Intravenous infusion
BNT316
Intravenous infusion
anti-B7-H3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
anti-HER3 antibody conjugated to topoisomerase I inhibitor
Intravenous infusion
Bispecific antibody for PD-L1 and VEGF-A
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
1. Participants must present with unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging Manual, Eighth Edition.
EXCEPT
2. Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving pre-trial chemoradiotherapy.
3. Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.
* Participants in Cohorts 2, 4, 5, 6, 10 and 11 must be able to tolerate (additional) anti-PD-1 therapy (i.e., did not permanently discontinue anti-programmed death protein 1 \[PD-1\] / programmed death ligand 1 \[PD-L1\] therapy due to toxicity).
* Participants must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) less than or equal to (\<=) 1, except for participants in Cohorts 1, 4, 5, 10 and 11 who are eligible with an ECOG-PS of 0-2.
Cohort 1:
* Participants prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen as well as one other line of systemic therapy (except if a participant is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor and/or another line of systemic therapy). Note: Participants newly enrolled in Cohort 1B under protocol v 5.0 and subsequent versions of the protocol must consent to mandatory blood sampling for peripheral blood mononuclear cells (PBMCs).
* Participants who are to start cemiplimab at Cycle 3 must present with PD-L1 expression of tumor proportion score (TPS) greater than or equal to (\>=) 1% in tumor cells (as determined locally).
Cohort 2:
* Participants must present with PD-L1 expression of tumor proportion score (TPS) \>= 50% in tumor cells (as determined locally prior to inclusion in this trial).
* Participants must present with progressive disease either
1. in the advanced or metastasized stage of NSCLC: while on a PD-1/PD-L1 inhibitor therapy or within 6 months of termination of this treatment as first-line treatment. Or
2. be refractory to ongoing adjuvant therapy/maintenance treatment after CRT with a PD-1/PD-L1 inhibitor that has been given for at least 3 months in monotherapy (i.e., after an initial combination therapy) before being enrolled into this trial.
Cohort 3:
* Participants prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor).
* Participants must present with progressive disease.
Cohort 4:
* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled if presenting with PD-L1 expression: TPS \>= 1% in tumor cells (as determined locally).
Cohort 5:
* Participants NSCLC must have been considered unresectable due to participant's condition and/or tumor-related factors and the participants must have undergone chemoradiotherapy before entering the trial.
Cohort 6:
* Participants NSCLC must be considered technically and medically resectable.
* Participants must be considered eligible for neo-adjuvant treatment.
Cohort 7:
* Participants prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor). Note 1: Participants may have received prior therapy targeting CTLA-4, lymphocyte-activation gene 3 (LAG-3), T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif \[ITIM\] domain (TIGIT), VEGF or VEGF receptor (VEGFR) inhibitor as monotherapy or part of a combination therapy. Note 2: If the participants' prior therapies included a CTLA-4 inhibitor, the participant must be able to tolerate (additional) treatment with the CTLA-4 inhibitor.
* Participants must present with progressive disease at trial enrollment.
* Participants must consent to mandatory blood sampling for PBMCs.
Cohorts 8 \& 9:
* Participants prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor).
* Participants must present with progressive disease at trial enrollment.
Cohort 10:
* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled.
Cohort 11:
* Participant's NSCLC must have been considered unresectable due to participants condition and/or tumor related factors and the participants must have undergone chemoradiotherapy before entering the trial.
Exclusion Criteria
* Presence of a driver mutation for which approved target therapies are available except if the participant is not a candidate for the respective targeted therapy.
* Ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events. Note: Participants with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.
* Current evidence of new or growing brain or spinal metastases during screening. Participants with leptomeningeal disease are excluded. Participants with known brain or spinal metastases may be eligible for all Cohorts, except for Cohorts 5, 6 and 11, if they:
* had radiotherapy or another appropriate therapy for the brain or spinal metastases, AND
* have no neurological symptoms that can be attributed to the current brain lesions, AND
* have stable brain or spinal disease on the computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent (confirmed by stable lesions on two scans at least 4 weeks apart), AND
* do not require steroid therapy for the treatment of brain or spinal metastases within 14 d before the first dose of trial treatment. Note: Spinal bone metastases (that is, of the vertebrae) are allowed, unless imminent fracture or cord compression is anticipated.
* Systemic immune suppression:
* Current use of chronic systemic steroid medication (\<= 5 mg/day prednisolone equivalent is allowed); participants using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible. Note: Steroid medication given for supportive or prophylactic reasons during CRT for participants in Cohorts 5 and 11 needs to be tapered to \<= 5 mg/day prednisolone equivalent at latest on the day before the trial treatment starts.
* Other clinically relevant systemic immune suppression within the last 3 months before trial enrollment.
* Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell (CD4+) counts less than (\<) 350 cells/microlitre (mcL) and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
* Prior splenectomy.
* History/risk of interstitial lung disease or low baseline lung function (baseline pulse oximetry of less than 92% oxygen saturation \[SpO2\] without additional oxygen).
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Scientia Clinical Research
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Universitätsklinikum Köln
Cologne, , Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, , Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, , Germany
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, , Hungary
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
Clinexpert Ltd
Gyöngyös, , Hungary
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, , Poland
NZOZ Medpolonia Sp. Z o.o
Poznan, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, , Poland
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Adana Sehir Hospital
Adana, , Turkey (Türkiye)
Haceteppe Hospital
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, , Turkey (Türkiye)
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Koc University Hospital
Istanbul, , Turkey (Türkiye)
University Medical Faculty Oncology Institute
Istanbul, , Turkey (Türkiye)
Yeditepe University
Istanbul, , Turkey (Türkiye)
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, , Turkey (Türkiye)
Dokuz Eylul Medical School
Izmir, , Turkey (Türkiye)
Adana Sehir Hospital
Yüreğir, , Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Velindre NHS Trust
Cardiff, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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BioNTech clinical trials patient information
Role: CONTACT
Phone: +49 6131 9084
Email: [email protected]
Other Identifiers
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2021-004739-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509283-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT116-01
Identifier Type: -
Identifier Source: org_study_id