Phase 2/3 EIK1001 TLR7/8 agonist + pembrolizumab chemo in 1L stage 4 NSCLC

This global, multicenter, randomized, double-blind, placebo-controlled adaptive Phase 2/3 trial (TeLuRide-008) tests whether adding Eikon Therapeutics’ EIK1001—an IV Toll-like receptor 7/8 (TLR7/8) innate immune agonist—can improve outcomes when combined with pembrolizumab (Merck/MSD’s PD-1 antibody) plus histology-appropriate platinum-doublet chemotherapy. Participants with previously untreated stage 4 NSCLC are randomized to placebo + pembrolizumab + chemo versus one of two EIK1001 dose levels + the same backbone, with Phase 2 dose optimization/expansion feeding into Phase 3 confirmatory testing. Eligibility focuses on predominantly squamous or non-squamous NSCLC where mutation-directed first-line therapy is not indicated (e.g., no actionable EGFR/ALK/RET/ROS1/BRAF alterations), reflecting the large “non-oncogene-addicted” population. The key angle is whether systemic innate immune priming (TLR7/8 activation) can deepen or broaden checkpoint responses on top of the current first-line standard: pembrolizumab with carboplatin/pemetrexed for non-squamous or carboplatin with paclitaxel or nab-paclitaxel for squamous disease.