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 (May 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 — This first-in-human (FIH) trial 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, 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 trial will comprise of several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above. The trial 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, and resectable NSCLC of Stage II and III in Cohort 6.
Check if I qualifyExtracted eligibility criteria
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 tumor proportion score (TPS) >= 50% in tumor cells (as determined locally prior to inclusion in this trial).
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).
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
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
Must have received: systemic therapy
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)
Must have received: chemoradiotherapy
participants must have undergone chemoradiotherapy before entering the trial
Cannot have received: ongoing active systemic treatment against NSCLC
Ongoing active systemic treatment against NSCLC
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
- MD Anderson Cancer Center · Houston, Texas
- NEXT Virginia · Fairfax, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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