Evaluating a new cancer vaccine for advanced non-small cell lung cancer
Official title: LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
Run by BioNTech SE · NCT05142189 · Data updated 2026-11-12
This study is testing a new cancer vaccine to see if it can help people with advanced non-small cell lung cancer feel better, either on its own or with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | BioNTech SE Industry-sponsored |
| Drugs / interventions | cemiplimab, osimertinib, chemotherapy, prednisone |
| Locations | 45 sites (Lexington, Kentucky and 44 other locations) |
| Status | Recruiting |
| Started | June 17, 2022 |
| Main results expected | February 2030 |
| Study ends | November 2031 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT05142189 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this trial are patients with unresectable or metastatic non-small cell lung cancer, including those with specific stages of the disease as outlined in the trial cohorts.
✕Probably not a fit
Patients with early-stage resectable non-small cell lung cancer may not benefit from this trial as it focuses on advanced disease stages.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is designed to assess the safety, tolerability, and preliminary efficacy of BNT116, a novel cancer vaccine, both as a standalone treatment and in combination with other approved and investigational therapies for patients with advanced non-small cell lung cancer (NSCLC). The trial includes multiple cohorts targeting different stages of NSCLC, allowing for a comprehensive evaluation of the vaccine's effectiveness in various treatment settings. Participants will receive treatment for up to 24 months, depending on their cohort, with the aim of establishing a safe dosage and understanding the vaccine's potential in combination therapies.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced non-small cell lung cancer, potentially improving survival rates and quality of life.
How similar studies have gone: Other studies have shown promise with similar cancer vaccine approaches, indicating potential for success in this novel treatment strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States Recruiting -
Norton Cancer Institute
Louisville, Kentucky, United States Recruiting -
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
NEXT Virginia
Fairfax, Virginia, United States Recruiting
Show 39 more locations
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Scientia Clinical Research
Randwick, New South Wales, Australia Recruiting -
Royal North Shore Hospital
Sydney, New South Wales, Australia Recruiting -
Cancer Research SA
Adelaide, South Australia, Australia Recruiting -
Monash Health
Clayton, Victoria, Australia Recruiting -
Universitätsklinikum Köln
Cologne, Germany Recruiting -
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany Recruiting -
University Medical Center Hamburg-Eppendorf
Hamburg, Germany Recruiting -
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany Recruiting -
National Institute of Oncology
Budapest, Hungary Recruiting -
Clinexpert Ltd
Gyöngyös, Hungary Recruiting -
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland Recruiting -
Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland Recruiting -
NZOZ Medpolonia Sp. Z o.o
Poznan, Poland Recruiting -
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, Spain Recruiting -
Hospital Universitario Vall d'Hebron
Barcelona, Spain Recruiting -
MD Anderson Cancer Center
Madrid, Spain Recruiting -
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain Recruiting -
START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)
Madrid, Spain Recruiting -
Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)
Santiago de Compostela, Spain Recruiting -
Hospital Universitario Virgen Macarena
Seville, Spain Recruiting -
Hospital Universitario y Politecnico La Fe
Valencia, Spain Recruiting -
Adana City Training and Research Hospital
Adana, Turkey (Türkiye) Recruiting -
Haceteppe Hospital
Ankara, Turkey (Türkiye) Recruiting -
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Turkey (Türkiye) Recruiting -
Ankara City Hospital
Ankara, Turkey (Türkiye) Recruiting -
Koc University Hospital
Istanbul, Turkey (Türkiye) Recruiting -
University Medical Faculty Oncology Institute
Istanbul, Turkey (Türkiye) Recruiting -
Yeditepe University
Istanbul, Turkey (Türkiye) Recruiting -
Ege University School of Medicine Tulay Aktas Oncology Hospital
Izmir, Turkey (Türkiye) Recruiting -
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom Recruiting -
Velindre NHS Trust
Cardiff, United Kingdom Recruiting -
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom Recruiting -
Guy's and St Thomas NHS Foundation Trust
London, United Kingdom Recruiting -
University College London Hospitals NHS Foundation Trust
London, United Kingdom Recruiting -
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom Recruiting -
ICON-PRA Budapest, Fázis 1 Vizsgálóhely
Budapest, Hungary Completed -
Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai Klinika
Budapest, Hungary Completed -
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland Withdrawn -
Dokuz Eylul Medical School
Izmir, Turkey (Türkiye) Completed
Study contacts
- Study coordinator: BioNTech clinical trials patient information
- Email: patients@biontech.de
- Phone: +49 6131 9084
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.