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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07111520 | A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) | PHASE1 | RECRUITING | 420 | — | — | Sep 22, 2025 | Jan 1, 2030 | May 5, 2026 | 68 | United States, Australia +8 |
During the DLT evaluation period by dose level
Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
| Arm | Type | Description |
|---|---|---|
| Part 1 - BNT326 (DL1, starting dose) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with second-line (or higher) 2L(+), squamous or non-squamous NSCLC, actionable genomic alterations (AGA)-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 1 - BNT326 (DL3, optional) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1. |
| Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with first-line (1L) squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1. |
| Part 2b (Cohort C, Arm 1) - BNT326 (DL1) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or epithelial growth factor receptor (EGFR) activating mutation, any PD-L1. |
| Part 2b (Cohort C, Arm 2) - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1. |
| Part 2b (Cohort C, Arm 3) - BNT326 monotherapy | EXPERIMENTAL | BNT326 monotherapy (DL2). In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1. |
| Part 2b (Cohort D1, Arm 1) - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. |
| Part 2b (Cohort D1, Arm 2) - Pembrolizumab | ACTIVE_COMPARATOR | Pembrolizumab monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. |
| Part 2b (Cohort D1, Arm 3) - BNT327 monotherapy | EXPERIMENTAL | BNT327 monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. |
| Part 2b (Cohort D2, Arm 1) - BNT326 (DL2) + BNT327 | EXPERIMENTAL | Combination therapy of BNT326 and BNT327. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. |
| Part 2b (Cohort D2, Arm 2) - SoC - Pembrolizumab + chemotherapy | ACTIVE_COMPARATOR | Combination therapy of pembrolizumab and chemotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. |
| Name | Type | Description |
|---|---|---|
| BNT326 | DRUG | intravenous (IV) infusion |
| BNT327 | DRUG | IV infusion |
| Pembrolizumab | DRUG | IV infusion |
| SoC | DRUG | IV infusion. Combination chemotherapy (pemetrexed, paclitaxel, or carboplatin). Chemotherapy will be selected according to the indication. |
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. * Have measurable disease defined by RECIST v1.1. * All participants have to provide a tumor tissue sample (e.g. Formalin-fixed paraffin-embedde...