Study of Bemcentinib with Pembrolizumab, Carboplatin, and Pemetrexed for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with STK11 Mutation

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically the advanced or metastatic form that is non-squamous. The study is particularly interested in cases with or without a mutation in the STK11 gene. The treatment being tested involves a combination of medications, including Bemcentinib, which is taken orally in capsule form, and a group of drugs used in chemoimmunotherapy. These include Pembrolizumab, Carboplatin, and Pemetrexed, all of which are administered through an intravenous infusion.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment. Participants will receive the treatment as a first-line option, meaning it is the initial treatment given for their cancer. The study will be conducted in two phases. The first phase will focus on determining the safety and appropriate dosage of the treatment combination. The second phase will assess how well the treatment works in reducing the size of the cancer or controlling its growth, especially in patients with the STK11 mutation.

Throughout the study, participants will be monitored for any side effects and the overall response of their cancer to the treatment. The study aims to provide valuable information on the potential benefits of combining Bemcentinib with standard chemoimmunotherapy drugs for treating advanced NSCLC. The trial is expected to continue until 2025, with the goal of improving treatment options for patients with this type of lung cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Eligibility is based on having advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable mutations or with an STK11 mutation.

2 treatment cycle 1

The first treatment cycle begins with the administration of medications. This includes pemetrexed and carboplatin given through an intravenous (IV) infusion.

Additionally, bemcentinib is taken orally in capsule form at a dose of 100 mg.

3 treatment cycle 2

In the second cycle, the same medications are administered. Pemetrexed and carboplatin are given intravenously.

The oral dose of bemcentinib is adjusted to 75 mg.

4 treatment cycle 3

The third cycle involves the administration of pemetrexed and pembrolizumab intravenously.

The oral dose of bemcentinib is further adjusted to 50 mg.

5 ongoing assessment

Throughout the trial, regular assessments are conducted to monitor the body’s response to the treatment.

These assessments include imaging tests and laboratory evaluations to track the progress of the disease and any side effects.

6 completion of trial

The trial is expected to continue until October 2025, with regular follow-ups to evaluate the effectiveness and safety of the treatment.

The primary goal is to determine the safety and tolerability of the treatment combination, as well as its impact on tumor activity.

Who Can Join the Study?

The person must provide written permission to join the study before any tests or procedures begin. If the person cannot do this, a legally acceptable representative can provide permission.
The person must be at least 18 years old on the day they sign the permission form.
The person must have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be cured with current treatments. This applies to Phase 1b of the study, regardless of PD-L1 status and without specific genetic changes that can be targeted by treatments.
For Phase 2a of the study, the person must have a confirmed diagnosis of advanced or metastatic non-squamous NSCLC with a specific genetic change called the STK11 mutation, and the cancer cannot be cured with current treatments. This also applies regardless of PD-L1 status and without specific genetic changes that can be targeted by treatments.
If the person has received previous treatments like chemotherapy, immunotherapy, or radiotherapy with the aim to cure non-metastatic cancer, they must have had a break of at least 6 months since the last treatment before joining the study.
The person must have a disease that can be measured according to specific guidelines called RECIST 1.1. If the cancer is in an area that was previously treated with radiation, it can still be measured if it has shown signs of getting worse.

Who Cannot Join the Study?

Patients who have not received treatment for their advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with or without a specific genetic change called the STK11 mutation.
Patients with other types of lung cancer that are not non-squamous non-small cell lung cancer.
Patients who have already received treatment for their advanced or metastatic lung cancer.
Patients with lung cancer that has a different genetic change that can be targeted with specific treatments, known as actionable mutations.
Patients who are not in the age range specified for the study.
Patients who are not willing or able to follow the study procedures.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of certain other medical conditions that the study doctors think might affect the study results.

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	Status
Institut Gustave Roussy	Villejuif	France
Koranyi National Institute For Pulmonology	Budapest	Hungary

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
MD Anderson Cancer Center	Madrid	Spain
Henry Dunant Hospital Center	Athens	Greece
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
General University Hospital Of Larissa	Larissa	Greece
Med Polonia Sp. z o.o.	Poznan	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Alexandra Hospital	Athens	Greece
Semmelweis University	Budapest	Hungary
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hopital Beaujon	Clichy	France
L’Hopital Prive Du Confluent	Nantes	France
Iiczss Iqcuclzx Fdjfmfhdhoibh Otowcdecpwk	Rome	Italy
Lkvwi Gdomgux Hsenxktf Oa Aqisri	Athens	Greece
Aaqlqum Uhv Tqdhdzq nvfe okniu	Leghorn	Italy
Agoscfu Ugjed Scyqdawqo Levrkn Dh Bsknhan	Bologna	Italy
Isdpnguf Cswupu Dxmashqrvhjcoobyk	L'hospitalet De Llobregat	Spain
Fsdkcawzl Pzmn Ll Iaxzdmycxpvvs Bkalsszvx Dyg Hqabrtpp Uvbhumydckddp Lb Poa	Madrid	Spain
Hucqfcka Vpnc dlhzesie	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.08.2023
Greece	Not recruiting	01.08.2023
Hungary	Not recruiting	01.08.2023
Italy	Not recruiting	01.08.2023
Poland	Not recruiting	01.08.2023
Spain	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Bemcentinib is a medication being studied for its potential to enhance the effects of other cancer treatments. In this trial, it is combined with other therapies to see if it can improve outcomes for patients with advanced or metastatic non-squamous non-small cell lung cancer. Researchers are looking at how well patients tolerate this medication and its potential to help fight the cancer.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in this trial to see if it can work effectively with other treatments to improve the condition of patients with advanced lung cancer.

Carboplatin is a chemotherapy drug that works by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this study, it is used in combination with other therapies to evaluate its effectiveness in treating advanced lung cancer.

Pemetrexed is another chemotherapy medication that interferes with the growth of cancer cells. It is used in this trial to see if it can help improve the treatment outcomes for patients with advanced non-squamous non-small cell lung cancer when used alongside other therapies.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, leading to the formation of tumors. NSCLC is known for its slow progression compared to other types of lung cancer, but it can spread to other parts of the body if not managed. The disease is often diagnosed at an advanced stage, where it may have already metastasized. In some cases, genetic mutations like STK11 can influence the behavior and progression of the cancer.

Trial ID:

2024-511007-41-00

Protocol code:

BGBC016

NCT ID:

NCT05469178

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Bemcentinib with Pembrolizumab, Carboplatin, and Pemetrexed for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with STK11 Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?