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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE3 | ACTIVE NOT_RECRUITING | 756 | — | — | Mar 21, 2025 | Sep 1, 2029 | Mar 18, 2026 | 147 | United States, Argentina +25 |
| Arm | Type | Description |
|---|---|---|
| efti + Standard of Care arm | EXPERIMENTAL | Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy |
| Placebo + Standard of Care arm | PLACEBO_COMPARATOR | Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy |
| Name | Type | Description |
|---|---|---|
| eftilagimod alfa | BIOLOGICAL | 30 mg of efti every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total |
| carboplatin plus paclitaxel | DRUG | For participants with squamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: carboplatin area under the curve (AUC) 5 or 6 in combination with paclitaxel 175 mg/m2 or 200 mg/m2 |
| cisplatin or carboplatin + pemetrexed | DRUG | For participants with nonsquamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: cisplatin 75 mg/m2 or carboplatin AUC 5 or 6 in combination with pemetrexed 500 mg/m2. After the initial 4 cycles, pemetrexed 500 mg/m2 maintenance therapy will be administered every 3 weeks |
| pembrolizumab (KEYTRUDA®) | BIOLOGICAL | 200 mg pembrolizumab (KEYTRUDA®) every 3 weeks i.v. for up to approximately 24 months |
| Placebo | OTHER | efti-matching placebo every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total |
Inclusion Criteria Participants may be enrolled if they meet all of the following criteria at screening: 1. Willing to give written informed consent and to comply with the protocol. 2. Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) non-sma...