Clinical Trial for Advanced Non-Small Cell Lung Cancer with BNT116
This study is testing a new treatment called BNT116, by itself and in combination with other approved medicines like cemiplimab, docetaxel, carboplatin, and paclitaxel. It's for people aged 18 and older with advanced non-small cell lung cancer (NSCLC). The main goals are to find out if BNT116 is safe, how well people tolerate it, and if it shows early signs of helping to treat the cancer. Researchers are looking for side effects and how often they occur. You may be eligible if you have advanced NSCLC that can be measured, though some groups don't need measurable disease. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 320 participants.
- What's involved
- Treatment duration varies by group, lasting up to 24 months for most, 12 months for others, and a combination of neo-adjuvant and adjuvant treatment for one group.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 27 months after their first dose of the investigational medicinal product.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentBioNTech SE
~320 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BNT116CemiplimabDocetaxelCarboplatinPaclitaxelBNT316
At a glance
Recruiting sites
41 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation Period
Measured over From first dose of IMP up to 21 days
+3 more outcomes measured
Conditions
Where it's being run
45 sites across 14 statesTurkey (Türkiye)9
Spain8
United Kingdom6
Germany4
Hungary4
Poland4
Kentucky2
New South Wales2
Study leadership
- BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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).
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
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.
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).
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.
Participants' NSCLC must be considered technically and medically resectable.
Participants must be considered eligible for neo-adjuvant treatment.
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.
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.
Participants who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled.
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.
Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.
Participants must have ongoing treatment with osimertinib.
Participants' NSCLC must have ALK rearrangement or RET rearrangement.
Participants must have ongoing treatment with a standard of care ALK TKI or RET TKI.
Exclusion
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).
What this trial measures
- Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation PeriodFrom first dose of IMP up to 21 days
Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
- Cohorts 1 to 11, EGFR and ALK/RET: Occurrence of Treatment-Emergent Adverse Events (TEAEs) Reported by Relationship, Seriousness, and Gradeup to 27 months
According to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0). Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
- Cohort 6 only: Occurrence of Post-Surgical Adverse Events (AEs) Related to BNT116 and Cemiplimabup to 27 months
- Cohort 6 only: Occurrence of Treatment-Related Delays to Surgery More Than 9 weeks Post the Last Dose of Neo-Adjuvant Treatmentup to 6 months