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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
University Hospital Jena KöR	Jena	Germany
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Haematologie-Onkologie im Zentrum MVZ GmbH	Augsburg	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Del Mar	Barcelona	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Vitaz	Sint-Niklaas	Belgium
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Mnt Healthcare Europe S.R.L.	Pantelimon	Romania
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Spitalul Clinic Coltea	Bucharest	Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Jessa Ziekenhuis	Hasselt	Belgium
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
CHC MontLegia	Liege	Belgium
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH	Hemer	Germany
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Provita Centrum Medyczne Sp. z o.o.	Tomaszow Mazowiecki	Poland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cmgrdoq Pmajekhz Szdpbe	Sibiu	Romania
Cmulnh Lyjc Bkkfhs	Lyon	France
Ijdjlm Icplcgtm Fudqcxjgfzdpm Oxasmgajmbi	Rome	Italy
Hakqogxn Ubqmlyobqefgx Mokmjaw Ds Vlsuyxurwd	Santander	Spain
Ablnrmv Omexcpchhco S Gkqtzvjy Apxvstizcb	Rome	Italy
Rdp Onidjbkd Giht	Oldenburg In Holstein	Germany
Uvocjjrcie Hpbvokla Coeekwq	Cologne	Germany
Ikogbdyf Rcwesojpb Ppp Lw Sfhggs Dxn Tlnkft Dawg Ahlkfem Ivzc Szmoyw	Meldola	Italy
Gqrmar Umrwawwdyc Ffaihsabo	Frankfurt	Germany
Udflnyiebqzdogxocffgt Wghazoeiy Apx	Wuerzburg	Germany
Atrnqzu Ulbta Spsvvgmxm Ljxrxn Dk Bmekkob	Bologna	Italy
Uoxwtnoxkqjdnh Cnpsoih Kgevbnvtc	Gdansk	Poland
Htguzifn Do Lb Sgeyd Cipt I Sncv Pbc	Barcelona	Spain
Hpotcaon Uquolgdctxweu dz A Cxbwrl	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.05.2025
France	Recruiting	15.05.2025
Germany	Recruiting	15.05.2025
Italy	Recruiting	15.05.2025
Poland	Recruiting	15.05.2025
Romania	Not yet recruiting	15.05.2025
Spain	Recruiting	15.05.2025

Trial locations

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.

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 ID:

2024-514465-18-00

Protocol code:

M24-536

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of ABBV-400 and Budigalimab for Adults with Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?