Study on Inupadenant, Carboplatin, and Pemetrexed for Adults with Metastatic Non-Small Cell Lung Cancer After Immunotherapy

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as nonsquamous non-small cell lung cancer. This is a common form of lung cancer that does not involve the squamous cells, which are flat cells found in the lining of the airways. The study is testing a new treatment that combines a medication called Inupadenant HCl with two other cancer drugs, carboplatin and pemetrexed. Inupadenant HCl is an experimental drug that is being tested to see if it can help improve the effectiveness of the other two medications in treating this type of lung cancer.

The purpose of the study is to evaluate how well this combination of drugs works and how safe it is for patients who have already tried other treatments, such as immunotherapy, but have not seen improvement. The study is divided into two parts. In the first part, researchers will determine the best dose of Inupadenant HCl to use with carboplatin and pemetrexed. In the second part, they will compare the effects of the drug combination to a placebo, which is a substance with no active medication, to see if the combination is more effective.

Participants in the study will take the medications in capsule form by mouth. The study will monitor the participants over a period to observe any side effects and to measure how the cancer responds to the treatment. The goal is to find out if this new combination of drugs can help control the cancer and improve the quality of life for patients with this type of lung cancer.

1 Joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving the medication inupadenant hydrochloride and the other receiving a placebo. Both groups will also receive standard chemotherapy drugs, carboplatin and pemetrexed.

2 Medication administration

The patient will take inupadenant hydrochloride or a placebo orally in the form of a capsule. The specific dosage and frequency will be determined during the study’s initial phase, known as the dose-finding phase.

In addition to the study medication, the patient will receive carboplatin and pemetrexed as part of their treatment regimen. These medications are standard chemotherapy drugs used to treat lung cancer.

3 Monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the safety and effectiveness of the treatment. This includes checking for any side effects or adverse reactions to the medications.

The patient’s response to the treatment will be evaluated using imaging tests to measure the size of the cancer and determine if it is responding to the treatment.

4 Study duration

The study is expected to continue until April 2027. During this time, the patient will continue to receive the assigned treatment and participate in regular assessments as outlined in the study protocol.

Who Can Join the Study?

Must have signed a form that shows you agree to participate in the study, approved by a special ethics committee.
Must be 18 years or older at the time of signing the consent form.
Must have a confirmed diagnosis of nonsquamous non-small cell lung cancer that is either spread to other parts of the body (Stage IV) or is advanced and cannot be removed by surgery (Stage III), and has come back or gotten worse.
Must have a disease that can be measured using specific criteria, with at least one area of the disease that has not been treated with radiation before.
Must have information about PD-L1 expression status available before joining the study. PD-L1 is a protein that can affect the immune system’s response to cancer.
Must be able to provide a sample of the tumor from a previous biopsy done within the last 4 years, or have a tumor that can be safely biopsied again.
Must have had the cancer come back or get worse after receiving a specific type of therapy called anti-PD-1/PD-L1 therapy. This therapy helps the immune system fight cancer. Specific conditions apply based on previous treatments.
Must have adequate organ function, confirmed by recent lab tests. This includes:
- Enough white blood cells and platelets, and a certain level of hemoglobin without recent blood transfusions.
- Good kidney function, measured by a test called glomerular filtration rate.
- Normal liver function, with specific levels of bilirubin and liver enzymes.
- Normal blood clotting ability, unless taking medication that affects clotting.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which means you are fully active or have some symptoms but can still carry out light work.

Who Cannot Join the Study?

Patients with a different type of lung cancer than nonsquamous non-small cell lung cancer cannot participate. This type of cancer is a specific form of lung cancer that does not involve squamous cells, which are flat cells found in the lining of the airways.
Patients who have not been diagnosed with nonsquamous non-small cell lung cancer are excluded.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely receive the study medications, carboplatin and pemetrexed, are excluded. These are chemotherapy drugs used to treat cancer.
Patients who are part of a vulnerable population that the study cannot safely include are excluded. This means people who might be at higher risk of harm from participating in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
SLK-Kliniken Heilbronn GmbH	Heilbronn	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Jessa Ziekenhuis	Hasselt	Belgium
Hospital Universitario Lucus Augusti	Lugo	Spain
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.	Peschiera Del Garda	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
CHU Helora	La Louviere	Belgium
Universita Degli Studi Di Brescia	Brescia	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centro Oncologico De Galicia	A Coruna Galicia	Spain
Direction Centrale Du Service De Sante Des Armees	Toulon	France
Cwiayv Llcn Bawzuf	Lyon	France
Homiwoju Ukfycaciucvpg Mzzwyqi Dd Viznwhcniu	Santander	Spain
Hnevvusq Ufjvehofudzcm Dh Byffucj	Badajoz	Spain
Evepdgm	Mechelen	Belgium
Alrkaun Uvn Trjhhaa nsnk owjos	Leghorn	Italy
Altyreaana Pwklkhdh Hgbhsixk Dl Mhjmxtacg	Marseille	France
Kienntqo Eshxmckhwzwqypkomyjjnzjs Hczrmevpnzzddsdzk	Essen	Germany
Htoduoyk Vpum djlbpmfw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.06.2022
Czechia	Not recruiting	30.06.2022
France	Not recruiting	30.06.2022
Germany	Not recruiting	30.06.2022
Italy	Not recruiting	30.06.2022
Spain	Not recruiting	30.06.2022

Trial locations

Investigated drugs:

Inupadenant Hydrochloride

Inupadenant is an investigational medication being studied for its potential to treat nonsquamous non-small cell lung cancer. In this trial, it is being tested in combination with other cancer treatments to determine its safety, tolerability, and effectiveness. The goal is to find the best dose to use in further studies.

Carboplatin is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, carboplatin is used in combination with other treatments to assess its effectiveness in patients who have not responded to previous immunotherapy.

Pemetrexed is another chemotherapy medication used to treat lung cancer. It targets and disrupts the growth of cancer cells by interfering with their ability to use folic acid, which is necessary for cell division. In this study, pemetrexed is combined with other treatments to evaluate its role in improving patient outcomes.

Investigated diseases:

Non-small cell lung cancer metastatic

Nonsquamous non-small cell lung cancer – This is a type of lung cancer that originates in the tissues of the lung, specifically in cells that are not squamous cells. It is one of the most common types of lung cancer and includes subtypes such as adenocarcinoma and large cell carcinoma. The disease typically progresses by forming tumors in the lungs, which can grow and spread to other parts of the body. As the cancer advances, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression can vary greatly among individuals, with some experiencing slow growth and others facing rapid advancement. Understanding the specific subtype and stage of the cancer is crucial for determining its progression.

Trial ID:

2024-515393-27-00

Protocol code:

A2A-005

NCT ID:

NCT05403385

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Inupadenant, Carboplatin, and Pemetrexed for Adults with Metastatic Non-Small Cell Lung Cancer After Immunotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?