Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | RECRUITING | 320 | — | — | Jun 17, 2022 | Nov 1, 2031 | Apr 14, 2026 | 44 | United States, Australia +6 |
Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.
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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 1B - BNT116 Monotherapy | EXPERIMENTAL | - |
| Cohort 2 - BNT116 + Cemiplimab (PD-1/PD-L1 Inhibitor Refractory/Relapsed Participants) | EXPERIMENTAL | - |
| Cohort 3 - BNT116 + Docetaxel | EXPERIMENTAL | - |
| Cohort 4 - BNT116 + Cemiplimab (Frail Participants) | EXPERIMENTAL | - |
| Cohort 5 - BNT116 + Cemiplimab (After Concurrent Chemoradiotherapy [CRT]) | EXPERIMENTAL | - |
| Cohort 6 - BNT116 + Cemiplimab + Carboplatin + Paclitaxel | EXPERIMENTAL | BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab |
| Cohort 7 - BNT116 + BNT316 | EXPERIMENTAL | Dose finding for the combination of BNT116 with BNT316 (CTLA4 antibody) with dose escalation of BNT316 |
| Cohort 8: BNT116 + Anti-B7-H3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose finding for the combination of BNT116 with an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 9: BNT116 + Anti-HER3 Antibody Conjugated to Topoisomerase I Inhibitor | EXPERIMENTAL | Dose confirmation for the combination of BNT116 with an anti-HER3 antibody conjugated to a topoisomerase I inhibitor with dose escalation of the anti-HER3 antibody conjugated to a topoisomerase I inhibitor |
| Cohort 10: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (Frail Participants) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) will be established. |
| Cohort 11: BNT116 + Bispecific Antibody for PD-L1 and VEGF-A (After Concurrent CRT) | EXPERIMENTAL | Dose confirmation for BNT116 in combination with a bispecific antibody for PD-L1 and VEGF-A will be established in participants after concurrent CRT. |
| Cohort EGFR : BNT116 + osimertinib | EXPERIMENTAL | Dose confirmation for BNT116 in combination with ongoing osimertinib therapy. Treatment with osimertinib is standard of care. Cohort will enroll only at selected sites in the US. |
| Cohort ALK/RET: BNT116 + ALK TKI or RET TKI | EXPERIMENTAL | 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. Cohort will enroll only at selected sites in the US. |
| Name | Type | Description |
|---|---|---|
| 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 |
Key Inclusion Criteria: * 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. 1. Participants must present with unresectable Stage III or metastatic Stage IV NSCLC b...