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
- Cachoeiro de Itapemirim, Rio de Janeiro, and Salvador, BrazilSee the 3 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage 4 non-small cell lung cancer (squamous or non-squamous) who have not yet had drug treatment for advanced disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage 4 non-small cell lung cancer, mostly squamous or non-squamous, with at least 1 measurable lesion. Life expectancy of at least 3 months.
- Earlier treatment
- No earlier drug treatment for advanced or metastatic lung cancer. Treatment given after or before surgery or radiation can count if the cancer came back more than 1 year after it ended.
- Biomarker or test result
- Tests must show no tumor mutations or fusions (for example EGFR, ALK, RET, ROS1, BRAF) that have an approved first-line targeted therapy. Tumor tissue must be available for PD-L1 testing.
Main reasons for not taking part
- Small cell elements in the tumor, or tumors that are not mostly squamous or non-squamous
- Investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of EIK1001 or placebo
- Major surgery less than 3 weeks before the first dose
- Live-virus vaccine within 30 days before starting
- Radiation therapy within 7 days before the first dose
Read by machine on 9 November 2026.
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 Brazil
- Hospital Evangelico de Cachoeiro de ItapemirimCachoeiro de Itapemirim, BrazilTaking people
- Oncoclínicas Rio de JaneiroRio de Janeiro, BrazilTaking people
- Nucleo de Oncologia da BahiaSalvador, BrazilTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.