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EIK1001, Pembrolizumab, and Chemotherapy for Stage 4 Non-Small Cell Lung Cancer in Patients with Stage 4 Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying Stage 4 Non-Small Cell Lung Cancer, which is a lung cancer that has spread to other parts of the body. The study is testing pembrolizumab together with EIK1001 and chemotherapy to see whether this combination can help people live longer and keep the cancer from getting worse for a longer time.

Participants are assigned by chance to receive either EIK1001 with pembrolizumab and chemotherapy, or a placebo with pembrolizumab and chemotherapy. The study is done in different parts and includes two doses of EIK1001 to help find the best dose. Treatment is given over time, with regular study visits and follow-up while the cancer and side effects are watched.

The main purpose of the study is to compare how well the treatment combinations work and how safe they are. Progression-free survival means the time before the cancer gets worse or the person dies, and overall survival means the time before death from any cause. The study also looks at side effects and whether treatment has to be stopped because of them.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study assignment</b>

    After joining the study, you are assigned to one of the study groups by chance. The study is double-blind, which means that neither you nor the study team knows whether you receive eik1001 or placebo.

    The placebo is an inactive control that looks the same as eik1001 but does not contain the study drug substance.

  2. Step 2

    <b>study treatment period</b>

    You receive pembrolizumab by intravenous infusion at a dose of 200 mg. Intravenous means that the medicine is given through a vein.

    You also receive either eik1001 or placebo by intravenous administration. The study medicine dose is 125 mg/m2 for eik1001, where mg/m2 means the dose is based on body surface area.

    You receive chemotherapy together with the study medicines. The study information states that this is nsq/sq chemotherapy, but the exact drugs, dose, frequency, and duration are not provided in the source data.

    The study compares eik1001 + pembrolizumab + chemotherapy with placebo + pembrolizumab + chemotherapy.

  3. Step 3

    <b>monitoring during the study</b>

    Your disease is followed during the study to see whether it gets worse, stays stable, or improves.

    The study measures progression-free survival, which means the time from randomization until the disease gets worse or death occurs, whichever happens first.

    The study also measures overall survival, which means the time from randomization until death from any cause.

    The study looks at objective response, which means whether the cancer shrinks enough to meet study rules for a response.

    The study also records side effects and whether any study treatment is stopped because of a side effect.

  4. Step 4

    <b>study follow-up and evaluation</b>

    During the study, scans or assessments are used to check the cancer according to recist 1.1, which is a standard set of rules for measuring tumor changes.

    Some results are reviewed by bicr, which means an independent central review of the scan results.

    The study also measures duration of response, which means the time from the first sign of a response until the disease gets worse or death occurs.

Who can join the trial?

11 criteria

  • Be at least 18 years old when signing the informed consent form, which is the document that gives permission to join the study.
  • Have a life expectancy of at least 3 months, meaning the doctor expects the person to live at least that long.
  • Have stage 4 non-small cell lung cancer (NSCLC) confirmed by tissue testing or cell testing. The cancer should be mainly squamous or non-squamous. People with NSCLC-NOS (“not otherwise specified,” meaning the type is not clearly classified) will be treated as having non-squamous NSCLC for this study.
  • Be considered a good candidate for standard treatment with pembrolizumab and chemotherapy.
  • Have proof that mutation-directed therapy is not needed. This means there are no known cancer changes, called mutations or fusions, such as EGFR, ALK, RET, ROS1, or BRAF, for which approved targeted treatments are available in the participant’s country.
  • Have at least 1 measurable tumor lesion at the start of the study. A lesion is an area of cancer that can be measured. The size must be measurable using RECIST 1.1, which is a standard way to measure tumor growth or shrinkage. If the lesion is in an area that was treated with radiation before, it can still count if it has clearly grown after treatment.
  • Not have received prior systemic therapy for advanced or metastatic NSCLC. Systemic therapy means treatment that travels through the whole body, such as chemotherapy or immunotherapy.
  • May still qualify if they had adjuvant or neoadjuvant treatment before. Adjuvant treatment is given after surgery or radiation, and neoadjuvant treatment is given before surgery. To qualify, the cancer must have come back more than 1 year after finishing that treatment.
  • Have an ECOG Performance Status of 0 to 1 within 10 days before treatment starts. This is a scale that shows how well a person can do daily activities. A score of 0 means fully active, and 1 means able to do light work.
  • Have tumor tissue available for testing from a place that was not previously treated with radiation. The tissue should ideally come from after the diagnosis of metastatic disease, which means cancer that has spread. If a newer biopsy is not possible, an older biopsy may be used if it is less than 3 years old and was taken before adjuvant or neoadjuvant chemotherapy.
  • Have adequate organ and bone marrow function based on the study’s laboratory tests. This means the main organs and the bone marrow, which makes blood cells, must be working well enough for study treatment. The required blood and lab samples must be collected within 10 days before treatment begins.

Who cannot join the trial?

27 criteria

  • Has lung cancer that is small cell type, or the cancer is not mainly non-squamous or squamous non-small cell lung cancer. "Non-squamous" and "squamous" are lung cancer cell types.
  • Has taken part in another study of an experimental treatment recently, and received that treatment within 4 weeks or 5 half-lives (whichever is longer) before starting this study. A half-life is the time it takes for half of a drug to leave the body.
  • Has had major surgery less than 3 weeks before the first study dose.
  • Received a live-virus vaccine within 30 days before starting the study. A live-virus vaccine contains a weakened live virus.
  • Received radiation therapy within 7 days before the first study dose. Radiation therapy uses high-energy rays to treat cancer.
  • Completed palliative radiotherapy within 7 days before the first study dose. Palliative radiotherapy is radiation used to ease symptoms, not to cure the cancer.
  • Is expected to need any other cancer treatment during the study, besides the study treatment itself.
  • Has active brain or spinal fluid cancer spread known as CNS metastases or carcinomatous meningitis. CNS means the brain and spinal cord. Some people with treated and stable brain metastases may still be allowed if they meet all study rules.
  • Has a severe allergic reaction or strong sensitivity to pembrolizumab, any part of that medicine, or to any component of carboplatin, cisplatin, paclitaxel, nab-paclitaxel, or pemetrexed. An allergic reaction means the body reacts badly to a medicine.
  • Has non-squamous NSCLC and is taking pemetrexed but cannot stop aspirin or other NSAIDs for the required time before each dose, except for low-dose aspirin. NSAIDs are pain-relief medicines such as ibuprofen. Also excluded if the person will not take folic acid or vitamin B12, or has symptomatic ascites or pleural effusion. Ascites means fluid in the belly; pleural effusion means fluid around the lungs.
  • Has a QTcF value above 470 ms on the heart tracing at screening. QTcF is a measure of the heart’s electrical timing, and ms means milliseconds.
  • Has active autoimmune disease that needed systemic treatment in the past 2 years. Autoimmune disease means the immune system attacks the body. Systemic treatment means treatment that affects the whole body.
  • Has an immune system problem, or is taking chronic systemic steroids in a dose higher than 10 mg of prednisone equivalent per day, or any other immunosuppressive therapy within 7 days before the first study dose. Immunosuppressive therapy lowers the activity of the immune system. Replacement hormones are allowed when they are only replacing what the body lacks.
  • Is on long-term systemic steroids. Some local or inhaled steroid use, or occasional bronchodilators, is allowed. Bronchodilators are medicines that open the airways.
  • Has an active infection that needs treatment.
  • Has uncontrolled HIV infection. HIV is a virus that weakens the immune system. People with HIV may only join if it is well controlled, with the required blood count, no recent AIDS-related opportunistic infection, and stable anti-HIV treatment.
  • Has HIV and a history of Kaposi’s sarcoma or multicentric Castleman’s disease. These are rare diseases linked to immune system problems and certain viruses.
  • Has a positive test showing active hepatitis B or hepatitis C infection, unless the specific virus rules in the study are met. Hepatitis is inflammation of the liver caused by a virus.
  • Has any illness, treatment, or lab result that could make the study results unclear, stop full participation, or is considered unsafe by the study doctor.
  • Has a psychiatric condition or substance abuse problem that would make it hard to follow the study rules. Psychiatric means related to mental health.
  • Is a regular user of illegal drugs at the time of consent, or has had recent substance abuse within the last year, including alcohol.
  • Has had pneumonitis that needed steroids, or has current pneumonitis. Pneumonitis is inflammation of the lungs.
  • Has had a previous organ transplant or allogenic transplant. Allogenic means from another person.
  • Is pregnant, breastfeeding, planning to become pregnant, planning to breastfeed, or plans to father children during the study period.
  • Is taking medicines known to be strong CYP3A4 or CYP1A2 inhibitors or inducers. These are medicines that can strongly change how other medicines are broken down in the body.
  • Has a history or current sign of diverticulitis, intra-abdominal abscess, bowel obstruction, or peritoneal carcinomatosis. Diverticulitis is inflammation of small pouches in the bowel; an abscess is a pocket of infection; bowel obstruction means the bowel is blocked; peritoneal carcinomatosis means cancer spread to the lining of the abdomen.
  • Has a past cancer other than the cancer being studied, unless it was treated with the goal of cure and there has been no sign of it coming back for 5 years. This time rule does not apply to certain fully removed skin, bladder, cervical, or other in-situ cancers. In-situ means very early cancer that has not spread.
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Investigated drugs

  • Pembrolizumab

    is an immunotherapy given through a vein. It helps the immune system find and attack cancer cells. In this trial, it is used together with chemotherapy and EIK1001 to treat advanced non-small cell lung cancer.

  • EIK1001

    is an experimental medicine given by injection into a vein. It is being tested to see if it can help improve cancer control when added to pembrolizumab and chemotherapy. The study is looking at whether it can help patients live longer without the cancer getting worse and whether it can improve overall survival.

  • Chemotherapy

    is a standard cancer treatment used together with the study medicine and pembrolizumab. In this trial, it is part of the treatment plan for people with stage 4 non-small cell lung cancer. Its role is to help kill cancer cells and work alongside the other medicines to slow the disease.

What is already known about the treatment

pembrolizumab - Pembrolizumab is given as an intravenous infusion, which means it is delivered slowly into a vein by a healthcare professional. It is an approved and widely used cancer medicine in modern medical practice and research, especially for several advanced cancers, including non-small cell lung cancer. It is a type of immunotherapy called a PD-1 inhibitor, and it works by blocking a signal that cancer cells use to hide from the immune system, helping immune cells recognize and attack the tumor.

Investigated diseases

Stage IV Non-Small Cell Lung Cancer - A form of lung cancer that has spread beyond the lung to distant parts of the body or to far areas within the chest. It usually grows and spreads over time, with cancer cells continuing to divide and form new tumors in other tissues. Symptoms and problems often become more widespread as the disease advances.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-525013-23-00Protocol codeEIK1001-008Estimated enrolment727 patientsSponsorEikon Therapeutics Inc.

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