Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EIK1001 · 3 trials · 4 indications
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
OS defined as the time from the first dose of study medication to death due to any cause
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Progression-free survival (PFS) is defined as the time from the date of randomization to documented progressive disease per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Objective Response (OR; defined as participants who demonstrate confirmed complete response \[CR\] or partial response \[PR\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 as assessed by the Investigator) (Dose Optimization Only).
Adverse events (AEs), and discontinuation of study treatment due to an AE (Dose Optimization Only). An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity.
| Arm | Type | Description |
|---|---|---|
| Arm 1 (Placebo in Combination with SOC) | PLACEBO_COMPARATOR | Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). |
| Arm 2 (EIK1001 in Combination with SOC) | EXPERIMENTAL | Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). |
| Arm 3 (EIK1001 in Combination with SOC) | EXPERIMENTAL | Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). |
| Arm 1 | ACTIVE_COMPARATOR | Participants in this arm will receive Placebo and Standard of Care (Pembrolizumab). |
| Arm 2 | EXPERIMENTAL | Participants in this arm will receive EIK1001 (selected dose 1) + Standard of Care (Pembrolizumab). |
| Arm 3 | EXPERIMENTAL | Participants in this arm will receive EIK1001 (selected dose 2) + Standard of Care (Pembrolizumab). |
| Cohort A - Participants with non-squamous NSCLC | EXPERIMENTAL | Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
| Cohort B - Participants with squamous NSCLC | EXPERIMENTAL | Participants in this arm will receive EIK1001 + Standard of Care (SOC). |
| Name | Type | Description |
|---|---|---|
| EIK1001 | DRUG | EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist |
| Pembrolizumab (KEYTRUDA®) | DRUG | PD-1 inhibitor |
| Placebo | DRUG | Placebo control |
| Paclitaxel + Carboplatin | DRUG | SOC Chemotherapy for squamous NSCLC |
| Nab-paclitaxel + Carboplatin | DRUG | SOC Chemotherapy for squamous NSCLC |
| Pemetrexed + Cisplatin /Carboplatin | DRUG | SOC Chemotherapy for non-squamous NSCLC |
| Pembrolizumab (KEYTRUDA® ) | DRUG | Pembrolizumab is a PD-1 inhibitor. |
| Pembrolizumab | DRUG | PD-1 inhibitor |
| Paclitaxel | DRUG | Chemotherapy |
| Pemetrexed | DRUG | Chemotherapy |
| Carboplatin | DRUG | Chemotherapy |
Key Inclusion Criteria: 1. Participant must be ≥ 18 years old at the time of signing the informed consent. 2. Participant has a life expectancy of at least 3 months. 3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered ...