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Study of ABBV-400 and Budigalimab for Adults with Advanced or Metastatic Non-Squamous 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 focused on studying a type of lung cancer known as advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The study is investigating the effects of a new treatment combination involving two medications: ABBV-400 and Budigalimab. ABBV-400 is an experimental drug that is being tested for its potential to treat this type of lung cancer. Budigalimab is another investigational medication that works by targeting specific proteins in the body to help the immune system fight cancer cells.

The purpose of this study is to evaluate the safety and effectiveness of the combination of ABBV-400 and Budigalimab in patients with advanced or metastatic non-squamous NSCLC. Participants in the study will receive these medications through an intravenous infusion, which means the drugs are given directly into the bloodstream through a vein. The study will monitor participants for any side effects and changes in their cancer to determine the best dose for future studies.

Throughout the study, participants will be closely observed to assess how their cancer responds to the treatment. The study aims to find out if this combination can help control the disease and improve the quality of life for patients with this type of lung cancer. The trial will continue until the researchers gather enough information to understand the treatment's impact on the disease.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to evaluate the safety and effectiveness of a combination of medications for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes confirming that you have not received prior systemic therapy for advanced NSCLC and that you do not have any actionable genomic alterations.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive a combination of medications through intravenous infusion. The medications include ABBV-400 and budigalimab. The specific dosage and frequency will be determined by the study team based on your individual needs and the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, you will be closely monitored for any side effects or changes in your condition. Regular follow-up visits will be scheduled to assess your response to the treatment and to ensure your safety.

  5. Step 5

    End of study

    The study is expected to conclude by November 26, 2027. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

10 criteria

  • The patient must have a type of lung cancer called Advanced or Metastatic Non-Squamous NSCLC.
  • The patient must not have had any previous treatments that affect the whole body for their lung cancer, such as:
    • PD-L1/PD-L2 inhibitors - medicines that help the immune system fight cancer.
    • CTLA-4 inhibitors - another type of medicine that helps the immune system attack cancer cells.
    • TIM 3 inhibitors - medicines that target specific proteins to help the immune system.
    • Any other treatments that help the immune system fight cancer.
    • The patient may have had treatments before surgery or after surgery, or radiation therapy, as long as it is allowed by the study rules.
    • The patient must have had one previous treatment for their advanced or metastatic lung cancer.
    • The patient can be of any gender.
    • The patient must be within the age range specified by the study, which includes adults and older adults.
    • The study is not for vulnerable populations, which means it is not for people who might need special protection or care.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not Advanced or Metastatic Non-Squamous NSCLC cannot participate.
  • Patients who have had a severe allergic reaction to similar medications in the past are not eligible.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, that are not well-managed cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with active infections, such as HIV or hepatitis, cannot take part in the study.
  • Patients with a history of drug or alcohol abuse within the past year are not eligible.
  • Patients who have had major surgery within the last 4 weeks are excluded.
  • Patients with a history of certain heart conditions, such as heart attack or heart failure, cannot participate.
  • Patients who are unable to comply with the study procedures and follow-up visits are not eligible.
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Investigated drugs

  • ABBV-400

    is a medication being studied to see how safe and effective it is for people with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC). This medication is being tested to find the best dose that can be used in future studies. It is being used in combination with another medication to see if it can help treat this type of cancer, especially in patients who have not received treatment for advanced disease before and do not have certain genetic changes in their cancer.

  • Budigalimab

    is another medication being tested in this study. It is used together with ABBV-400 to see if the combination can help treat advanced non-squamous non-small cell lung cancer. The study aims to find out if this combination is safe and how well it works in treating the cancer. Budigalimab is part of the treatment plan to see if it can improve the outcomes for patients with this type of lung cancer.

What is already known about the treatment

  • ABBV-400

    ABBV-400 is administered as an injection and is currently being studied in clinical trials for its potential use in treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). It is not yet widely available in medical practice, as it is still under investigation to determine its safety, effectiveness, and the best dose to use. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. ABBV-400 is classified as an investigational drug, meaning it is still being tested and is not yet approved for general use.

  • Budigalimab

    Budigalimab is also administered as an injection and is being tested in combination with ABBV-400 for treating advanced or metastatic non-squamous NSCLC. Like ABBV-400, it is still in the clinical trial phase and not yet approved for widespread medical use. Budigalimab works by modulating the immune system to enhance its ability to fight cancer cells. It is classified as a monoclonal antibody, a type of drug designed to target specific proteins involved in disease processes.

Investigated diseases

Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer – This type of lung cancer originates in the tissues of the lung, specifically in cells that are not squamous in nature. It is characterized by the uncontrolled growth of abnormal cells in the lung, which can form tumors. As the disease progresses, these cancerous cells can spread beyond the lungs to other parts of the body, a process known as metastasis. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. Over time, the cancer can affect the function of the lungs and other organs it spreads to. The disease is typically diagnosed at an advanced stage, where it has already spread beyond the original site.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514465-18-00Protocol codeM24-536Estimated enrolment252 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).