NSCLC
Conditions
Keywords
Squamous, Nonsquamous, Metastatic
Brief summary
This study is for patients with advanced/metastatic non-small cells lung cancer (NSCLC) who have not received any treatment through the vein for the advanced disease.
Detailed description
This is a multicenter open-label phase 2 trial that aim to assess the safety, tolerability, and efficacy of EIK1001 in combination with standard of care in participants with both confirmed stage 4 squamous and non-squamous NSCLC who have not received prior systemic therapy for the advanced disease. The study includes dose finding and evaluates adverse events and efficacy.
Interventions
DRUGEIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
DRUGPembrolizumab
PD-1 inhibitor
DRUGPaclitaxel
Chemotherapy
DRUGPemetrexed
Chemotherapy
DRUGCarboplatin
Chemotherapy
Sponsors
Eikon Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. be ≥ 18 years of age on the day of signing of informed consent. 2. confirmed Stage 4 NSCLC (squamous or non-squamous) and be considered for standard of care. 3. have confirmation that mutation-directed therapy is not indicated (documentation of absence of tumor activating mutations/fusions that are approved for first line therapy). 4. have at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined by the local site Investigator/radiology assessment. 5. have not received prior systemic treatment for advanced/metastatic NSCLC. 6. have an ECOG Performance Status of 0 to 1. 7. have adequate organ function.
Exclusion criteria
1. does not have predominantly squamous cell or non-squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. 2. is currently participating in or has participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is shorter) of administration of EIK1001. 3. prior to the first dose of EIK1001, has received prior systemic therapy for metastatic disease, or had major surgery (\< 3 weeks prior to the first dose). 4. has completed palliative radiotherapy within 7 days of the first dose of study drug administration. 5. has a known history of prior malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years. 6. has an active infection requiring therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with safety event during treatment | Up to 2 years | Defined AEs that occur during treatment and are deemed to be related EIK1001 or combination with SOC or due to disease progression or toxicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with objective response rate (ORR) and duration of response (DOR). | Up to 4 years | Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) by RECIST 1.1 and 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, as assessed by the investigator. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) at Final Follow-Up | Up to 4 years | OS defined as the time from the first dose of study medication to death due to any cause |
| Progression Free Survival (PFS) | Up to 4 years | Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression by RECIST 1.1 (Investigator) or death due to any cause, whichever occurs first |
Countries
United States
Contacts
Primary ContactGenevieve Doster
Outcome results
None listed