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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04686305 | Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC | PHASE1 | RECRUITING | 304 | — | — | Mar 9, 2021 | Jun 30, 2027 | Apr 13, 2026 | 91 | United States, Australia +17 |
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Arm 1A: T-DXd, Durvalumab and Cisplatin | EXPERIMENTAL | T-DXd, Durvalumab and Cisplatin |
| Arm 1B: T-DXd, Durvalumab and Carboplatin | EXPERIMENTAL | T-DXd, Durvalumab and Carboplatin |
| Arm 1C: T-DXd, Durvalumab and Pemetrexed | EXPERIMENTAL | T-DXd, Durvalumab and Pemetrexed (Arm not initiated) |
| Arm 1D: T-DXd | EXPERIMENTAL | T-DXd |
| Arm 3A: T-DXd and Volrustomig | EXPERIMENTAL | Drug: T-DXd and Volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig |
| Arm 3B: T-DXd, Volrustomig and Carboplatin | EXPERIMENTAL | Drug: T-DXd, Volrustomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig Drug: Carboplatin Carboplatin: administered as an IV infusion |
| Arm 4A: T-DXd and Rilvegostomig | EXPERIMENTAL | T-DXd and Rilvegostomig Drug: T-DXd, Rilvegostomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936 |
| Arm 4B T-DXd and Rilvegostomig with Carboplatin | EXPERIMENTAL | Drug: T-DXd, Rilvegostomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936 Drug: Carboplatin Carboplatin: administered as an IV infusion |
| Arm 5A: T-DXd and Volrustomig | EXPERIMENTAL | Drug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (priming dose in first cycle, fixed dose in subsequent cycles) Other Name: volrustomig |
| Arm 5B: T-DXd and Volrustomig | EXPERIMENTAL | Drug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (fixed dose from first cycle onward) Other Name: volrustomig |
| Name | Type | Description |
|---|---|---|
| T-DXd | DRUG | T-DXd: administered as an IV infusion |
| Durvalumab | BIOLOGICAL | Durvalumab: administered as an IV infusion |
| Cisplatin | DRUG | Cisplatin: administered as an IV infusion |
| Carboplatin | DRUG | Carboplatin: administered as an IV infusion |
| Pemetrexed | DRUG | Pemetrexed: administered as an IV infusion (drug not used) |
| Volrustomig | DRUG | Volrustomig: administered as an IV infusion |
| Rilvegostomig | DRUG | Rilvegostomig: administered as an IV infusion |
Inclusion criteria: * Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC * Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. * Part 3, Part 4 and Part 5: Patients must have tumors that do not harbor known genomic alter...