Table 3.
Ongoing clinical trials targeting novel therapeutic pathways in SCLC
| Study | Population | Drug | Function | Phase | Line | Sample size | State | Primary end point |
|---|---|---|---|---|---|---|---|---|
| DLL3 | ||||||||
| NCT04429087 | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | Obrixtamig (BI 764532) | T-cell connectors targeting DLL3 | phase I | ≥ 2 | / | Recruiting | MTD |
| DAREON-9 (NCT05990738) | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | Obrixtamig (BI 764532) + topotecan/single agent chemotherapy | T-cell connectors targeting DLL3 | phase 1b | ≥ 2 | 25 | Recruiting | DLTs, MTD |
| NCT05978284 | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | ZG006 | DLL3/DLL3/CD3 trispecific T-cell engager | phase II | ≥ 2 | 48 | Recruiting | DLTs, MTD |
| NCT06592638 | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | ZG006 | DLL3/DLL3/CD3 trispecific T-cell engager | phase I | ≥ 2 | / | Recruiting | DLTs, MTD |
| IDE849-001 (NCT07174583) | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | IDE849 | DLL3 ADC | phase I/II | ≥ 2 | / | Recruiting | Safety and Tolerability |
| DNA damage response modulator | ||||||||
| NCT05815160 | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | Debio0123 + etoposide + carboplatin | WEE1 kinase inhibitors | phase I | ≥ 2 | 16 | Recruiting | DLTs |
| B7-H3 | ||||||||
| NCT06954246 | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | MHB088C | B7-H3 ADC | phase I/II | ≥ 2 | 91 | Recruiting | ORR, OS |
| IDEate-Lung01 (NCT05280470) | SCLC; progressed 1 line of platinum-based treatment(including anti-PD-1/PD-L1) | Ifinatamab Deruxtecan (I-DXd) | B7-H3 ADC | phase II | ≥ 2 | 137 | Active, not recruiting | ORR |
Abbreviations: DLTs, dose limiting toxicities; MTD, maximum tolerated dose; ADC, antibody drug conjugate