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Study on Livmoniplimab and Budigalimab with Chemotherapy for Adults with Untreated Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic non-squamous non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive a combination of livmoniplimab and budigalimab along with chemotherapy, while the other group will receive pembrolizumab with chemotherapy. Chemotherapy involves using drugs to kill cancer cells, and in this study, it includes medications like carboplatin, cisplatin, and pemetrexed.

The purpose of the study is to find the best dose and to evaluate the safety and effectiveness of these treatment combinations. Participants will be randomly assigned to one of the two groups. The study will be conducted in two stages. In the first stage, the focus will be on assessing the safety and activity of the treatments to determine the best dose for the second stage. The second stage will compare the effectiveness of the two treatment combinations in terms of overall survival, which means how long patients live after starting the treatment.

Participants will receive their assigned treatments through intravenous infusions, which means the medication will be given directly into a vein. The study will last for several months, and participants will be monitored regularly to check for any side effects and to see how well the treatment is working. The study aims to provide valuable information that could help improve treatment options for people with this type of lung cancer.

1 initial treatment phase

The study begins with the administration of medications through an intravenous route. This involves the use of carboplatin, budigalimab, livmoniplimab, cisplatin, pembrolizumab, and pemetrexed. Each medication is provided as a solution for infusion.

The purpose of this phase is to assess the safety and activity of livmoniplimab and budigalimab in combination with chemotherapy. The goal is to determine the recommended dose for the next phase of the study.

2 evaluation of response

During this stage, the effectiveness of the treatment is evaluated. This involves measuring the best overall response, which includes complete or partial response to the treatment.

The primary focus is on progression-free survival, which refers to the length of time during and after the treatment that the patient lives with the disease without it getting worse.

3 dose determination

Based on the results from the initial treatment phase, the optimal dose of livmoniplimab is determined for the next stage of the study.

This involves selecting the recommended Phase 3 dose (RP3D) for livmoniplimab.

4 comparison phase

In this phase, the activity of the recommended dose of livmoniplimab and budigalimab in combination with chemotherapy is compared to pembrolizumab in combination with chemotherapy.

The main objective is to evaluate overall survival, which is the time from the start of the treatment until death from any cause.

5 ongoing assessment

Throughout the study, ongoing assessments are conducted to monitor the patient’s response to the treatment.

These assessments include measuring changes in physical functioning and quality of life, as well as tracking any adverse events.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of metastatic non-squamous non-small cell lung cancer (NSCLC). This means the cancer has spread to other parts of the body and is not of the squamous type.
  • The patient should not have specific genetic changes like EGFR or ALK mutations for which there is a targeted treatment available. These are specific changes in the cancer cells that can be treated with certain drugs.
  • The patient must have completed palliative radiotherapy more than 7 days before starting the study treatment. Palliative radiotherapy is a type of radiation treatment aimed at relieving symptoms rather than curing the disease.
  • The patient must have at least one measurable lesion as per specific criteria used to evaluate tumors. A lesion is an area of abnormal tissue, and measurable means it can be accurately measured to track changes.
  • The patient should have a life expectancy of at least 3 months and their organs should be functioning adequately.
  • The patient must have an ECOG performance status score of 0, 1, or 2. This score is used to assess how well a patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
  • Both male and female patients are eligible to participate.

Who Cannot Join the Study?

  • Patients who have already received treatment for their lung cancer cannot participate.
  • Patients with a different type of lung cancer than the one specified in the study are not eligible.
  • Patients with other serious health conditions that could interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have had another type of cancer in the past, unless it was successfully treated and is not currently active, are not eligible.
  • Patients with known allergies to the study drugs or similar medications cannot participate.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with a history of drug or alcohol abuse that could affect their ability to follow the study procedures are not eligible.
  • Patients with certain infections, such as HIV or hepatitis, are excluded from the study.
  • Patients who have had a major surgery or significant injury within a certain time frame before the study starts cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Centre Hospitalier Intercommunal Creteil Creteil France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Isala Klinieken Stichting Zwolle The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Az Maria Middelares Gent Gent Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Ziekenhuis St Jansdal Harderwijk The Netherlands
Micancer Center S.L.P. Barcelona Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
CHC MontLegia Liege Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Cyyswaksp Ukdzxaoeoqehgf Sewbwnccf Woluwe-Saint-Lambert Belgium
Ityzcbnz Ctdedq Dqrsdhkdezelghbks L'hospitalet De Llobregat Spain
Hpbayoz Jpblwzbb Haine-Saint-Paul Belgium
Admvchwxgd Pwzxarlq Hzlrqmuw Dl Mvaasgbkj Marseille France
Unmbwhexzi Op Aslyaxe Edegem Belgium
Hpdegmyk Vteq dmgsvocl Barcelona Spain
Ifxmbkhh Cbgts Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
31.08.2024
France France
Recruiting
31.08.2024
Spain Spain
Recruiting
31.08.2024
The Netherlands The Netherlands
Recruiting
31.08.2024

Trial locations

Investigated drugs:

Livmoniplimab is an experimental medication being tested for its safety and effectiveness in treating metastatic non-squamous non-small cell lung cancer. It is used in combination with other treatments to see if it can improve patient outcomes.

Budigalimab is another investigational drug used alongside livmoniplimab and chemotherapy. The study aims to determine if this combination can enhance the treatment of lung cancer.

Pembrolizumab is an established medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is combined with chemotherapy to compare its effectiveness against the new combination of livmoniplimab and budigalimab.

Platinum Doublet Chemotherapy is a standard chemotherapy treatment for lung cancer. It involves using two chemotherapy drugs together to increase the effectiveness of the treatment. This therapy is used in combination with the other medications being tested in the trial.

Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the non-squamous cells of the lung and has spread to other parts of the body. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue, which can form tumors. As the disease progresses, these cancerous cells can invade nearby tissues and organs, leading to metastasis. The spread of cancer cells to distant parts of the body can affect the function of vital organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course.

Trial ID:
2023-505773-32-00
Protocol code:
M23-721
NCT ID:
NCT06236438
Trial Phase:
Therapeutic use (Phase IV)

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