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Study Comparing Acasunlimab and Pembrolizumab with Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

Verified siteRegistered drugNo placebo
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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 focused on studying the effectiveness of a new treatment combination for patients with Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will compare the combination of two medications, Acasunlimab and Pembrolizumab, against a standard treatment called Docetaxel. These medications are given to patients who have already been treated with a type of therapy known as PD-1/PD-L1 inhibitors and chemotherapy containing platinum, which are common treatments for this cancer.

The purpose of the study is to determine if the combination of Acasunlimab and Pembrolizumab is more effective than Docetaxel in treating patients with NSCLC. Participants in the study will receive either the combination of Acasunlimab and Pembrolizumab or Docetaxel. The study will monitor the overall survival of participants, which means how long they live after starting the treatment. It will also look at other factors like how long the cancer does not get worse, the response of the cancer to the treatment, and any side effects experienced by the participants.

The study will take place over several years, and participants will be closely monitored throughout the process. The trial aims to provide valuable information on whether the new combination of treatments can offer better outcomes for patients with NSCLC compared to the current standard treatment. This research is important for developing more effective therapies for lung cancer patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of metastatic non-small cell lung cancer (NSCLC) and ensuring previous treatment with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

    Eligibility also requires a positive tumor PD-L1 expression and measurable disease according to specific criteria. A performance status score and adequate organ function are also assessed.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. One group receives a combination of acasunlimab and pembrolizumab, while the other group receives docetaxel.

  3. Step 3

    Treatment administration

    For the acasunlimab and pembrolizumab group, both medications are administered as an intravenous infusion. The specific dosage and frequency are determined by the trial protocol.

    Participants in the docetaxel group receive the medication intravenously, with dosage and frequency also specified by the trial protocol.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the effectiveness of the treatment and to identify any side effects. This includes measuring overall survival, progression-free survival, and response rates.

    Regular blood tests and imaging studies are conducted to monitor the disease and treatment effects.

  5. Step 5

    Completion and evaluation

    The trial continues until the estimated end date or until specific endpoints are reached. Participants' overall health and response to treatment are evaluated throughout the trial.

    The primary endpoint is overall survival, while secondary endpoints include progression-free survival and response rates.

Who can join the trial?

11 criteria

  • The participant must have **Non-Small Cell Lung Cancer (NSCLC)** that has spread to other parts of the body, known as **metastatic** NSCLC.
  • The participant must have been diagnosed with metastatic NSCLC through a test called **histology** or **cytology**, which examines tissue or cell samples.
  • The participant must have previously received treatment with a **PD-1/PD-L1 inhibitor** and **platinum-based chemotherapy**. This could be either:
    • One prior treatment where both were given together, or
    • No more than two prior treatments where they were given one after the other, in any order.
    • The participant's tumor must show **positive PD-L1 expression**, meaning at least 1% of the tumor cells have this marker, as determined by a specific test.
    • The participant must have a tumor that can be measured using a method called **RECIST v1.1**, which is a standard way to measure cancer response to treatment.
    • The participant must have an **ECOG performance status** score of 0 or 1, which indicates they are fully active or have some symptoms but do not need bed rest.
    • The participant must have a life expectancy of at least 3 months.
    • The participant must have **adequate organ and bone marrow function**, as shown by recent laboratory tests.
    • The participant must be an adult, as the study includes age ranges 18 years and older.
    • Both male and female participants are eligible for the study.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer cannot participate. This is a specific type of lung cancer.
  • Patients who have not previously received treatment with PD-1/PD-L1 inhibitors or platinum-based therapies are excluded. These are specific types of cancer treatments.
  • Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to provide informed consent or are part of a vulnerable population may be excluded. This means they might not fully understand the study or are in a situation that makes it hard for them to make decisions.
  • Patients who have other serious health conditions that could interfere with the study may be excluded. This is to ensure the safety and accuracy of the study results.
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Investigated drugs

  • Acasunlimab (GEN1046)

    is an investigational medication being studied for its potential to treat metastatic non-small cell lung cancer. It is being tested in combination with another medication to see if it can help improve outcomes for patients who have already received certain standard treatments.

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It is used in this trial in combination with acasunlimab to see if the two medications together can be more effective in treating lung cancer than other treatments.

  • Docetaxel

    is a chemotherapy drug that is used to treat various types of cancer, including lung cancer. In this trial, it is being used as a comparison to evaluate the effectiveness of the combination of acasunlimab and pembrolizumab.

What is already known about the treatment

  • Acasunlimab

    Acasunlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic non-small cell lung cancer (NSCLC). It is being evaluated in combination with pembrolizumab, compared to docetaxel, for patients who have previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy. Acasunlimab works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy agent.

  • Pembrolizumab

    Pembrolizumab is given through intravenous infusion and is an established medication in the treatment of various cancers, including non-small cell lung cancer. It is used in combination with acasunlimab in clinical trials to assess its efficacy in patients who have already undergone certain standard treatments. Pembrolizumab functions by blocking the PD-1 pathway, enhancing the immune system's ability to fight cancer cells. It belongs to the class of drugs known as immune checkpoint inhibitors.

  • Docetaxel

    Docetaxel is administered intravenously and is a well-known chemotherapy drug used in the treatment of various cancers, including non-small cell lung cancer. In the clinical trial, it serves as a comparator to evaluate the effectiveness of the acasunlimab and pembrolizumab combination. Docetaxel works by interfering with cell division, which prevents cancer cells from growing and spreading. It is classified as a taxane-based chemotherapy agent.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. The progression can vary significantly depending on the subtype and stage at diagnosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512998-27-00Protocol codeGCT1046-06Estimated enrolment702 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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