Non Small Cell Lung Cancer (Squamous or Non Squamous), Stage 4 NSCLC
Conditions
Keywords
Non Small Cell Lung Cancer, EIK1001
Brief summary
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Detailed description
This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).
Interventions
DRUGEIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
DRUGPembrolizumab (KEYTRUDA®)
PD-1 inhibitor
DRUGPlacebo
Placebo control
SOC Chemotherapy for squamous NSCLC
SOC Chemotherapy for squamous NSCLC
SOC Chemotherapy for non-squamous NSCLC
Sponsors
Eikon Therapeutics
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC. 4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country. 5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. 6. Participant has not received prior systemic therapy for advanced/metastatic NSCLC. Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible. 7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment. 8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \< 3yrs old). Key
Exclusion criteria
1. has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC. 2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo. 3. has had major surgery (\< 3 weeks prior to the first dose of study intervention administration). 4. has received a live-virus vaccination within 30 days of the start of study intervention initiation. 5. has received radiation therapy within 7 days of the first dose of study intervention administration. 6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Through study completion, up to 6 years | 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 |
| Overall survival (OS) | Through study completion, up to 10 years | OS defined as the time from the first dose of study medication to death due to any cause |
| Objective Response (OR) | Through study completion, up to 6 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response (OR) | Up to 6 years | Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR |
| Duration of response (DOR) | Up to 6 years | DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR. |
| Progression-free survival (PFS) by Investigator | Up to 6 years | 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 Investigator, or death due to any cause, whichever occurs first. |
| Overall Response Rate (ORR) by Investigator | Up to 6 years | Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator. |
| Duration of Response (DOR) by Investigator | Up to 6 years | DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator. |
| Incidence of Adverse Events (AEs) | Up to 2.5 years | Adverse Events (AEs) and discontinuation of study treatment due to any AE. |
Contacts
STUDY_DIRECTOREtah Kurland, MD
Eikon Therapeutics
Outcome results
None listed