EIK1001 added to pembrolizumab and chemotherapy for advanced non-small cell lung cancer
Tests EIK1001 with pembrolizumab and chemotherapy in adults with advanced non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
Key facts
- Where
- Bucharest and Cluj-Napoca, RomaniaSee the 2 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07365319, who can take part
Where in Romania
- Medicover Hospitals S.R.L.Bucharest, RomaniaTaking people
- Medisprof S.R.L.Cluj-Napoca, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eikon Therapeutics
- Trial code
- NCT07365319EU 2025-525013-23-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
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.
Inclusion: Participant must be ≥ 18 years old at the time of signing the informed consent; Participant has a life expectancy of at least 3 months; 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; 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; 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; 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; Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment; 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).
Exclusion: 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; has had major surgery (< 3 weeks prior to the first dose of study intervention administration); has received a live-virus vaccination within 30 days of the start of study intervention initiation; has received radiation therapy within 7 days of the first dose of study intervention administration; has completed palliative radiotherapy within 7 days of the first dose of study intervention administration; has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.