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Treatment with osimertinib is standard of care.\n\nCohort will enroll only at selected sites in the US.",[13,65],"Biological: Osimertinib",{"label":67,"type":10,"description":68,"interventionNames":69},"Cohort ALK\u002FRET: BNT116 + ALK TKI or RET TKI","Dose confirmation for BNT116 in combination with either ongoing ALK-inhibitor or ongoing RET-inhibitor therapy. Treatment with ALK TKI or RET TKI is standard of care.\n\nCohort will enroll only at selected sites in the US.",[13,70],"Biological: ALK-inhibitor or RET-inhibitor",[72,77,81,85,88,91,94,97,100,103,107],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":11},"BIOLOGICAL","BNT116","Intravenous injection",[53,58,9,15,18,22,26,29,32,38,43,48,67,62],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":11},"Cemiplimab","Intravenous infusion",[18,26,29,32],{"type":82,"name":83,"description":79,"armGroupLabels":84,"otherNames":11},"DRUG","Docetaxel",[22],{"type":82,"name":86,"description":79,"armGroupLabels":87,"otherNames":11},"Carboplatin",[32],{"type":82,"name":89,"description":79,"armGroupLabels":90,"otherNames":11},"Paclitaxel",[32],{"type":73,"name":92,"description":79,"armGroupLabels":93,"otherNames":11},"BNT316",[38],{"type":73,"name":95,"description":79,"armGroupLabels":96,"otherNames":11},"anti-B7-H3 antibody conjugated to topoisomerase I 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Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy","WITHDRAWN","Warsaw","02-781",{"type":131,"coordinates":322},[323,324],21.01178,52.22977,{"lat":324,"lon":323},{"facility":327,"status":124,"city":328,"state":11,"zip":329,"country":330,"countryCode":331,"cosmosGeoPoint":332,"geoPoint":336,"contacts":11},"Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol","Badalona","08916","Spain","ES",{"type":131,"coordinates":333},[334,335],2.24741,41.45004,{"lat":335,"lon":334},{"facility":338,"status":124,"city":339,"state":11,"zip":340,"country":330,"countryCode":331,"cosmosGeoPoint":341,"geoPoint":345,"contacts":11},"Hospital Universitario Vall d'Hebron","Barcelona","08035",{"type":131,"coordinates":342},[343,344],2.15899,41.38879,{"lat":344,"lon":343},{"facility":156,"status":124,"city":347,"state":11,"zip":348,"country":330,"countryCode":331,"cosmosGeoPoint":349,"geoPoint":353,"contacts":11},"Madrid","28033",{"type":131,"coordinates":350},[351,352],-3.70256,40.4165,{"lat":352,"lon":351},{"facility":355,"status":124,"city":347,"state":11,"zip":356,"country":330,"countryCode":331,"cosmosGeoPoint":357,"geoPoint":359,"contacts":11},"Hospital Universitario Fundacion Jimenez Diaz","28040",{"type":131,"coordinates":358},[351,352],{"lat":352,"lon":351},{"facility":361,"status":124,"city":347,"state":11,"zip":362,"country":330,"countryCode":331,"cosmosGeoPoint":363,"geoPoint":365,"contacts":11},"START Madrid - CIOCC. Grupo Hospital de Madrid (HM) - Centro Integral Oncologico Clara Campal (CIOCC)","28050",{"type":131,"coordinates":364},[351,352],{"lat":352,"lon":351},{"facility":367,"status":124,"city":368,"state":11,"zip":369,"country":330,"countryCode":331,"cosmosGeoPoint":370,"geoPoint":374,"contacts":11},"Complejo Hospitalario Universitario de Santiago de Compostela (CHUS) - Hospital Clinico Universitario (University Clinical Hospital)","Santiago de Compostela","15706",{"type":131,"coordinates":371},[372,373],-8.54569,42.88052,{"lat":373,"lon":372},{"facility":376,"status":124,"city":377,"state":11,"zip":378,"country":330,"countryCode":331,"cosmosGeoPoint":379,"geoPoint":383,"contacts":11},"Hospital Universitario Virgen Macarena","Seville","41009",{"type":131,"coordinates":380},[381,382],-5.97317,37.38283,{"lat":382,"lon":381},{"facility":385,"status":124,"city":386,"state":11,"zip":387,"country":330,"countryCode":331,"cosmosGeoPoint":388,"geoPoint":392,"contacts":11},"Hospital Universitario y 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Institute","34093",{"type":131,"coordinates":437},[430,431],{"lat":431,"lon":430},{"facility":440,"status":124,"city":426,"state":11,"zip":441,"country":397,"countryCode":11,"cosmosGeoPoint":442,"geoPoint":444,"contacts":11},"Yeditepe University","34718",{"type":131,"coordinates":443},[430,431],{"lat":431,"lon":430},{"facility":446,"status":124,"city":447,"state":11,"zip":448,"country":397,"countryCode":11,"cosmosGeoPoint":449,"geoPoint":453,"contacts":11},"Ege University School of Medicine Tulay Aktas Oncology Hospital","Izmir","35100",{"type":131,"coordinates":450},[451,452],27.13838,38.41273,{"lat":452,"lon":451},{"facility":455,"status":256,"city":447,"state":11,"zip":456,"country":397,"countryCode":11,"cosmosGeoPoint":457,"geoPoint":459,"contacts":11},"Dokuz Eylul Medical School","35330",{"type":131,"coordinates":458},[451,452],{"lat":452,"lon":451},{"facility":461,"status":124,"city":462,"state":11,"zip":463,"country":464,"countryCode":465,"cosmosGeoPoint":466,"geoPoint":470,"contacts":11},"Cambridge University Hospitals NHS Foundation Trust","Cambridge","CB2 0QQ","United Kingdom","UK",{"type":131,"coordinates":467},[468,469],0.11667,52.2,{"lat":469,"lon":468},{"facility":472,"status":124,"city":473,"state":11,"zip":474,"country":464,"countryCode":465,"cosmosGeoPoint":475,"geoPoint":479,"contacts":11},"Velindre NHS Trust","Cardiff","CF14 2TL",{"type":131,"coordinates":476},[477,478],-3.18,51.48,{"lat":478,"lon":477},{"facility":481,"status":124,"city":482,"state":11,"zip":483,"country":464,"countryCode":465,"cosmosGeoPoint":484,"geoPoint":488,"contacts":11},"The Clatterbridge Cancer Centre NHS Foundation Trust","Liverpool","L7 8YA",{"type":131,"coordinates":485},[486,487],-2.97794,53.41058,{"lat":487,"lon":486},{"facility":490,"status":124,"city":491,"state":11,"zip":492,"country":464,"countryCode":465,"cosmosGeoPoint":493,"geoPoint":497,"contacts":11},"Guy's and St Thomas NHS Foundation Trust","London","SE1 9RT",{"type":131,"coordinates":494},[495,496],-0.12574,51.50853,{"lat":496,"lon":495},{"facility":499,"status":124,"city":491,"state":11,"zip":500,"country":464,"countryCode":465,"cosmosGeoPoint":501,"geoPoint":503,"contacts":11},"University College London Hospitals NHS Foundation Trust","W1T 7HA",{"type":131,"coordinates":502},[495,496],{"lat":496,"lon":495},{"facility":505,"status":124,"city":506,"state":11,"zip":507,"country":464,"countryCode":465,"cosmosGeoPoint":508,"geoPoint":512,"contacts":11},"The Newcastle Upon Tyne Hospitals NHS Foundation Trust","Newcastle upon Tyne","NE7 7DN",{"type":131,"coordinates":509},[510,511],-1.61396,54.97328,{"lat":511,"lon":510},{"type":514,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100450184","phase-1-clinical-trial-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-bnt116-alone-and-in-combinations-in-patients-with-advanced-non-small-cell-lung-cancer-100450184",false,"NCT05142189","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: 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","LuCa-MERIT-1","Key Inclusion Criteria:\n\n* Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 do not have to present with measurable disease.\n\n  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.\n\n     EXCEPT\n  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.\n  3. Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.\n* 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\\] \u002F programmed death ligand 1 \\[PD-L1\\] therapy due to toxicity).\n* Participants must have an Eastern Cooperative Oncology Group performance status (ECOG-PS) less than or equal to (\\\u003C=) 1, except for participants in Cohorts 1, 4, 5, 10 and 11 who are eligible with an ECOG-PS of 0-2.\n\nCohort-specific inclusion criteria:\n\nCohort 1:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-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\u002For PD-1\u002FPD-L1 inhibitor and\u002For 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).\n* 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).\n\nCohort 2:\n\n* Participants must present with PD-L1 expression of tumor proportion score (TPS) \\>= 50% in tumor cells (as determined locally prior to inclusion in this study).\n* Participants must present with progressive disease either\n\n  1. in the advanced or metastasized stage of NSCLC: while on a PD-1\u002FPD-L1 inhibitor therapy or within 6 months of termination of this treatment as first-line treatment. Or\n  2. be refractory to ongoing adjuvant therapy\u002Fmaintenance treatment after CRT with a PD-1\u002FPD-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.\n\nCohort 3:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor).\n* Participants must present with progressive disease.\n\nCohort 4:\n\n* 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).\n\nCohort 5:\n\n* Participants' NSCLC must have been considered unresectable due to participant's condition and\u002For tumor-related factors and the participants must have undergone chemoradiotherapy before entering the study.\n\nCohort 6:\n\n* Participants' NSCLC must be considered technically and medically resectable.\n* Participants must be considered eligible for neo-adjuvant treatment.\n\nCohort 7:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-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.\n* Participants must present with progressive disease at study enrollment.\n* Participants must consent to mandatory blood sampling for PBMCs.\n\nCohorts 8 \\& 9:\n\n* Participants' prior therapy must have included at least a PD-1\u002FPD-L1 inhibitor and a platinum-based chemotherapy regimen (except if a participant is not a candidate for a platinum-based chemotherapy and\u002For PD-1\u002FPD-L1 inhibitor).\n* Participants must present with progressive disease at study enrollment.\n\nCohort 10:\n\n* Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled.\n\nCohort 11:\n\n* Participants' NSCLC must have been considered unresectable due to participants condition and\u002For tumor related factors and the participants must have undergone chemoradiotherapy before entering the study.\n\nCohort EGFR (will enroll only at selected sites in the US):\n\n* Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.\n* Participants must have ongoing treatment with osimertinib.\n\nCohort ALK\u002FRET (will enroll only at selected sites in the US):\n\n* Participants' NSCLC must have ALK rearrangement or RET rearrangement.\n* Participants must have ongoing treatment with a standard of care ALK TKI or RET TKI.\n\nKey Exclusion Criteria:\n\n* Ongoing active systemic treatment against NSCLC.\n* 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\u002FRET.\n* 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.\n* 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:\n* had radiotherapy or another appropriate therapy for the brain or spinal metastases, AND\n* have no neurological symptoms that can be attributed to the current brain lesions, AND\n* 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\n* 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.\n* Systemic immune suppression:\n* Current use of chronic systemic steroid medication (\\\u003C= 5 mg\u002Fday 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 \\\u003C= 5 mg\u002Fday prednisolone equivalent at latest on the day before the study treatment starts.\n* Other clinically relevant systemic immune suppression within the last 3 months before study enrollment.\n* Known history of seropositivity for human immunodeficiency virus (HIV) with cluster of differentiation 4 (CD4)+ T-cell (CD4+) counts less than (\\\u003C) 350 cells\u002Fmicrolitre (mcL) and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.\n* Prior splenectomy.\n* History\u002Frisk of interstitial lung disease or low baseline lung function (baseline pulse oximetry of less than 92% oxygen saturation \\[SpO2\\] without additional oxygen).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply to all or some participants depending on the cohort.","ALL","18 Years",{"count":526,"type":527},320,"ESTIMATED","INTERVENTIONAL",[530],"PHASE1","This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and\u002For in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC).\n\nThe study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.\n\nThe study 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, resectable NSCLC of Stage II and III in Cohort 6, advanced\u002Fmetastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced\u002Fmetastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK\u002FRET.\n\nCohort EGFR and Cohort ALK\u002FRET will enroll only at selected sites in the US.",[533],"Non-Small Cell Lung Cancer",[535,533,536,537,95,98,538,539,540,541,542,543,544,545,546],"Cancer Vaccine","Combination with chemotherapy","Combination with other investigational agents","Immunotherapy","Antibody-drug conjugate (ADC)","Anaplastic lymphoma kinase (ALK) rearranged Non-Small Cell Lung Cancer","Rearranged during transfection (RET) rearranged Non-Small Cell Lung Cancer","NSCLC","anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody","Epidermal growth factor receptor (EGFR)-mutant Non-Small Cell Lung Cancer","Combination with a programmed cell death protein 1 (PD-1) inhibitor","Human epidermal growth factor receptor 3","2026-04-09",{"date":549,"type":550},"2026-04-14","ACTUAL",{"date":552,"type":550},"2022-06-17",{"date":554,"type":527},"2031-11",{"name":5,"class":6},44]