Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (LuCa-MERIT-1)
Non-Small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Cancer Vaccine, Non-Small Cell Lung Cancer
Eligibility Criteria
Key Inclusion Criteria:
- Patients must have histologically confirmed unresectable Stage III or metastatic Stage IV NSCLC and measurable disease by RECIST v1.1. Note: Patients in Cohort 1 do not have to have measurable disease.
- Patients in Cohorts 2 and 4 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) and must have recovered to stage 1 or 0 from any previous PD-1/PD-L1-related toxicity or be on a stable hormone substitute therapy.
- Patients in Cohorts 2 and 3 must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) ≤1. Patients in Cohort 1 and 4 with an ECOG-PS of 0-2 are eligible.
Cohort-specific inclusion criteria:
Cohort 1:
- Patients' 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 patient is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor and/or another line of systemic therapy).
Cohort 2:
- Patients must present with PD-L1 expression of tumor proportion score (TPS) ≥50% in tumor cells (as determined locally prior to inclusion in this trial).
Patients must present with progressive disease either
- 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
- be refractory to ongoing adjuvant therapy 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:
- Patients' prior therapy must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a patient is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor).
Cohort 4:
- Patients' 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.
Key Exclusion Criteria:
- Ongoing active systemic treatment against NSCLC.
- Presence of a driver mutation for which approved target therapies are available.
- 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: Patients 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. Patients with leptomeningeal disease are excluded. Patients with known brain or spinal metastases may be eligible if they:
- had radiotherapy or another appropriate therapy for the brain or spinal bone 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 (i.e., 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); patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible.
- 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 <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
- Prior splenectomy.
Sites / Locations
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterRecruiting
- NEXT VirginiaRecruiting
- Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)Recruiting
- University Medical Center Hamburg-EppendorfRecruiting
- Universitätsklinikum KölnRecruiting
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeRRecruiting
- ICON-PRA Budapest, Fázis 1 VizsgálóhelyRecruiting
- Semmelweis Egyetem ÁOK Belgyógyászati és Onkológiai KlinikaRecruiting
- National Institute of OncologyRecruiting
- Clinexpert LtdRecruiting
- Uniwersyteckie Centrum KliniczneRecruiting
- Warminsko Mazurskie Centrum Chorob Pluc w OlsztynieRecruiting
- NZOZ Medpolonia Sp. Z o.oRecruiting
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyRecruiting
- Institut Catala d'Oncologia Badalona, Hospital Germans Trias I PujolRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- MD Anderson Cancer CenterRecruiting
- Hospital Universitario Fundacion Jimenez DiazRecruiting
- START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)Recruiting
- Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)Recruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Universitario y Politecnico La FeRecruiting
- Dr. Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
- Ankara City HospitalRecruiting
- Yeditepe UniversityRecruiting
- Ege University School of Medicine Tulay Aktas Oncology HospitalRecruiting
- Dokuz Eylul Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1A - BNT116 monotherapy
Cohort 1B - BNT116 monotherapy
Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)
Cohort 3 - BNT116 + docetaxel
Cohort 4 - BNT116 + cemiplimab (frail patients)
Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])
Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxel
BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab