OncoMatch/Clinical Trials/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
Is NCT05142189 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments for non-small cell lung cancer.
Treatment: BNT116 · Cemiplimab · Docetaxel · Carboplatin · Paclitaxel · BNT316 · anti-B7-H3 antibody conjugated to topoisomerase I inhibitor · anti-HER3 antibody conjugated to topoisomerase I inhibitor · Bispecific antibody for PD-L1 and VEGF-A · Osimertinib · ALK-inhibitor or RET-inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression (TPS >= 1%)
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).
Required: PD-L1 (CD274) expression (TPS >= 50%)
Participants must present with PD-L1 expression of TPS >= 50% in tumor cells (as determined locally prior to inclusion in this study).
Required: PD-L1 (CD274) expression (TPS >= 1%)
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).
Required: EGFR exon 19 deletion
Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.
Required: EGFR l858r
Participants' NSCLC must have classical EGFR mutations, i.e., ex19Del or L858R.
Required: ALK rearrangement
Participants' NSCLC must have ALK rearrangement or RET rearrangement.
Required: RET rearrangement
Participants' NSCLC must have ALK rearrangement or RET rearrangement.
Disease stage
Required: Stage III, IV, II (other)
unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging Manual, Eighth Edition
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG-PS <= 1, except for participants in Cohorts 1, 4, 5, 10 and 11 who are eligible with an ECOG-PS of 0-2.
Prior therapy
Must have received: anti-PD-1 therapy
Participants' prior therapy must have included at least a PD-1/PD-L1 inhibitor
Must have received: platinum-based chemotherapy
Participants' prior therapy must have included at least ... a platinum-based chemotherapy regimen
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kentucky Chandler Medical Center · Lexington, Kentucky
- Norton Cancer Institute · Louisville, Kentucky
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
- Ohio State University · Columbus, Ohio
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05142189 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-PD-1 therapy and platinum-based chemotherapy.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV or II is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify