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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) agonist
PD-1 inhibitor
Chemotherapy
Percentage of participants with safety event during 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.
Time frame: Up to 2 years
Percentage of participants with objective response rate (ORR) and duration of response (DOR).
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.
Time frame: Up to 4 years
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Chemotherapy
Chemotherapy
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