New lung cancer vaccine trial launches for advanced patients

NCT ID NCT05142189

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This early-stage trial is testing a new cancer vaccine called BNT116, alone or with other drugs, in people with advanced non-small cell lung cancer. The main goal is to find a safe dose and check for side effects. About 320 participants will be enrolled across several groups, including those with different stages of lung cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BNT116 (a cancer vaccine) alone or combined with other drugs like cemiplimab, docetaxel, or targeted therapies
What this could lead to: If successful, this could point toward a new treatment option for advanced lung cancer, potentially improving outcomes for patients who have few alternatives.
What could go wrong: This is a very early (Phase 1) trial focused on safety and dosing, so it is too soon to know if BNT116 will work. Side effects are unknown, and many early-stage trials do not lead to approved treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 as well as in Cohorts EGFR and ALK/RET do not have to present with measurable disease. 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-study 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 \[PD-1\] / 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-specific inclusion criteria: 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 TPS \>= 50% in tumor cells (as determined locally prior to inclusion in this study). * 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 study. 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 study. 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 study 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 study 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: * Participants' 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 study. Cohort EGFR (will enroll only at selected sites in the US): * Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R. * Participants must have ongoing treatment with osimertinib. Cohort ALK/RET (will enroll only at selected sites in the US): * Participants' NSCLC must have ALK rearrangement or RET rearrangement. * Participants must have ongoing treatment with a standard of care ALK TKI or RET TKI. Key Exclusion Criteria: * Ongoing active systemic treatment against NSCLC. * 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. EXCEPT participants in Cohort EGFR and Cohort ALK/RET. * 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 days before the first dose of study 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 study treatment starts. * Other clinically relevant systemic immune suppression within the last 3 months before study enrollment. * Known history of seropositivity for human immunodeficiency virus (HIV) with cluster of differentiation 4 (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 without additional oxygen). NOTE: Other protocol defined Inclusion/Exclusion criteria apply to all or some participants depending on the cohort.

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 lethal congenital contracture syndrome 2 multiple endocrine neoplasia type 2A non-small cell lung carcinoma type 1 diabetes mellitus 12

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

41 sites in 8 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Adana City Training and Research Hospital
RECRUITING

Adana, 01370, Turkey (Türkiye)
Ankara City Hospital
RECRUITING

Ankara, 06800, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
Cancer Research SA
RECRUITING

Adelaide, South Australia, 5000, Australia
Clinexpert Ltd
RECRUITING

Gyöngyös, 3200, Hungary
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
RECRUITING

Santiago de Compostela, 15706, Spain
Dokuz Eylul Medical School
COMPLETED

Izmir, 35330, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING

Ankara, 06200, Turkey (Türkiye)
Ege University School of Medicine Tulay Aktas Oncology Hospital
RECRUITING

Izmir, 35100, Turkey (Türkiye)
Guy's and St Thomas NHS Foundation Trust
RECRUITING

London, SE1 9RT, United Kingdom
Haceteppe Hospital
RECRUITING

Ankara, 06100, Turkey (Türkiye)
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING

Madrid, 28040, Spain
Hospital Universitario Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital Universitario Virgen Macarena
RECRUITING

Seville, 41009, Spain
Hospital Universitario y Politecnico La Fe
RECRUITING

Valencia, 46026, Spain
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
COMPLETED

Budapest, 1077, Hungary
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
RECRUITING

Badalona, 08916, Spain
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
RECRUITING

Baltimore, Maryland, 21287, United States
Koc University Hospital
RECRUITING

Istanbul, 34010, Turkey (Türkiye)
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
RECRUITING

Frankfurt, 60488, Germany
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
MD Anderson Cancer Center
RECRUITING

Madrid, 28033, Spain
Monash Health
RECRUITING

Clayton, Victoria, 3168, Australia
NEXT Virginia
RECRUITING

Fairfax, Virginia, 22031, United States
NZOZ Medpolonia Sp. Z o.o
RECRUITING

Poznan, 60-693, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
WITHDRAWN

Warsaw, 02-781, Poland
National Institute of Oncology
RECRUITING

Budapest, 1122, Hungary
Norton Cancer Institute
RECRUITING

Louisville, Kentucky, 40202, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210, United States
Royal North Shore Hospital
RECRUITING

Sydney, New South Wales, 2065, Australia
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
RECRUITING

Madrid, 28050, Spain
Scientia Clinical Research
RECRUITING

Randwick, New South Wales, 2031, Australia
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
COMPLETED

Budapest, 1083, Hungary
The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING

Liverpool, L7 8YA, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING

Newcastle upon Tyne, NE7 7DN, United Kingdom
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
RECRUITING

Mainz, 55131, Germany
University College London Hospitals NHS Foundation Trust
RECRUITING

London, W1T 7HA, United Kingdom
University Medical Center Hamburg-Eppendorf
RECRUITING

Hamburg, 20246, Germany
University Medical Faculty Oncology Institute
RECRUITING

Istanbul, 34093, Turkey (Türkiye)
University of Kentucky Chandler Medical Center
RECRUITING

Lexington, Kentucky, 40536, United States
Universitätsklinikum Köln
RECRUITING

Cologne, 50937, Germany
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gdansk, 80-214, Poland
Velindre NHS Trust
RECRUITING

Cardiff, CF14 2TL, United Kingdom
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
RECRUITING

Olsztyn, 10-357, Poland
Yeditepe University
RECRUITING

Istanbul, 34718, Turkey (Türkiye)

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