drugset / Trial / NCT06726265
Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC). Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.
Timeline
- Start
- 2025-03-21
- Primary completion
- 2027-06
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eftilagimod Alfa | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | — |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | — |