At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BNT116 (biological), Cemiplimab (biological), Docetaxel (drug), Carboplatin (drug)
- How long the study runs
- Study runs about 113 months (dates as stated)
- About the drug or intervention
- BNT116 — biological: Intravenous injection · Cemiplimab — biological: Intravenous infusion · Docetaxel — drug: Intravenous infusion · Carboplatin — drug: Intravenous infusion · Paclitaxel — drug: Intravenous infusion · BNT316 — biological: Intravenous infusion · anti-B7-H3 antibody conjugated to topoisomerase I inhibitor — biological: Intravenous infusion · anti-HER3 antibody conjugated to topoisomerase I inhibitor — biological: Intravenous infusion · Bispecific antibody for PD-L1 and VEGF-A — biological: Intravenous infusion · Osimertinib — biological: Oral · ALK-inhibitor or RET-inhibitor — biological: Oral
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 320
- Started
- 2022-06-17
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase1 - 320 participants
- • 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/or 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Cambridge - Cambridge University Hospitals NHS Foundation Trust
- • Cardiff - Velindre NHS Trust
- • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
- • London - Guy's and St Thomas NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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/or 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). The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The 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/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET. Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
More detail
The maximum duration of treatment for each individual participant in this study is: * Cohorts 1 to 4, Cohorts 7 to 10, Cohort EGFR, and Cohort ALK/RET: 24 months. * Cohorts 5 and 11: 18 cycles, i.e., 12 months. * Cohort 6: 4 cycles of neo-adjuvant treatment and 18 cycles of adjuvant treatment, i.e., 12 months of adjuvant treatment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ histologically confirmed NSCLC and measurable disease by RECIST v1
- ✓ must have included at least a PD-1/PD-L1 inhibit
- ✓ classical EGFR mutations, i
- ✓ ongoing treatment with osimertinib
What the study is looking for
- ✓Participants must present with unresectable Stage III or that has spread Stage IV NSCLC by American Joint Commission on...
- ✓EXCEPT
- ✓Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual,...
- ✓Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer...
- ✓Cohort-specific inclusion criteria:
Who cannot take part
- ✗Ongoing active systemic treatment against NSCLC.
- ✗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
- ✗Systemic immune suppression:
- ✗Other clinically relevant systemic immune suppression within the last 3 months before study enrollment.
See the full criteria
Where Is This Study? (6 UK sites)
Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Velindre NHS Trust
Cardiff CF14 2TL, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
Guy's and St Thomas NHS Foundation Trust
London SE1 9RT, United Kingdom
University College London Hospitals NHS Foundation Trust
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
BioNTech clinical trials patient information
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