Study Comparing Ivonescimab and Chemotherapy with Pembrolizumab and Chemotherapy for Patients with Metastatic Squamous Non-small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Metastatic Squamous Non-small Cell Lung Cancer, 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 ivonescimab (also known by the code name AK112 / SMT112) with chemotherapy drugs such as carboplatin and paclitaxel or nab-paclitaxel. The other group will receive pembrolizumab (also known as Keytruda) combined with the same chemotherapy drugs. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to compare the overall survival of patients receiving these different treatment combinations. Participants will be randomly assigned to one of the two groups. The study will involve regular visits to the clinic for treatment and monitoring. Treatments will be given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 24 months, during which participants will receive their assigned treatments and undergo regular health assessments to monitor their response to the treatment and any side effects.

Throughout the study, participants will be closely monitored for their health and well-being. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations for patients with Metastatic Squamous Non-small Cell Lung Cancer. Participants will also be assessed for any immune response to the treatments, such as the development of antibodies against ivonescimab. The results of this study could help improve treatment options for this type of lung cancer in the future.

1 initial visit

Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

You will be asked to sign a written informed consent form to confirm your voluntary participation.

2 screening tests

You will undergo a series of screening tests to ensure you meet the eligibility criteria. These tests will assess your organ function, including blood tests for hematology, kidney, and liver function.

A pregnancy test will be conducted for female patients of childbearing potential.

3 randomization

If eligible, you will be randomly assigned to one of two treatment groups. This means you will either receive ivonescimab combined with chemotherapy or pembrolizumab combined with chemotherapy.

4 treatment administration

You will receive your assigned treatment through an intravenous infusion. This involves receiving medication directly into your bloodstream through a vein.

The medications used include paclitaxel, paclitaxel albumin-bound, carboplatin, ivonescimab, and pembrolizumab. The specific combination and dosage will depend on your assigned group.

5 regular follow-up visits

You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and imaging studies to assess the progress of your condition.

The frequency and duration of these visits will be determined by the study protocol.

6 end of treatment

Once the treatment phase is complete, you will have a final visit to evaluate your overall health and the outcomes of the treatment.

You may be asked to continue attending follow-up visits for a specified period to monitor long-term effects.

Who Can Join the Study?

Must be at least 18 years old.
Must have a confirmed diagnosis of Metastatic Squamous Non-small Cell Lung Cancer (Stage IV).
Must have a Tumor Proportion Score (TPS) with PD-L1 expression or provide tissue for measurement of PD-L1 expression. PD-L1 is a protein that can affect the immune system’s ability to fight cancer.
Must have at least one measurable tumor that is not in the brain.
Must not have received any prior systemic treatment for metastatic Non-small Cell Lung Cancer (NSCLC). Previous treatments are allowed if they were completed at least 12 months before the cancer spread.
Must have an ECOG performance status score of 0 or 1. This score measures how well you can perform daily activities.
Must have an expected life expectancy of at least 3 months.
Must have adequate organ function, including:
- Blood: Sufficient levels of neutrophils, platelets, and hemoglobin.
- Kidneys: Sufficient creatinine clearance or estimated glomerular filtration rate (eGFR).
- Liver: Acceptable levels of bilirubin, AST, and ALT.
- Blood clotting: Normal prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT).
Female patients of childbearing age must have a negative pregnancy test before starting the study and agree to use effective contraception during the study and for 120 days after the last dose.
Male patients must agree to use effective contraception during the study and for 120 days after the last dose, and until 6 months after the last dose of carboplatin.
Must voluntarily sign a written informed consent form.

Who Cannot Join the Study?

Patients with other types of cancer that have spread to other parts of the body cannot participate.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back, cannot participate.
Patients who have had a serious allergic reaction to any of the study drugs cannot participate.
Patients with uncontrolled or serious heart problems cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments for cancer within a specific time frame before the study starts cannot participate.
Patients with a history of certain lung diseases cannot participate.
Patients who have had a major surgery within a specific time frame before the study starts cannot participate.
Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk	Lublin	Poland

Other Sites

Site Name	City	Country
Azienda Sanitaria Territoriale Di Pesaro E Urbino	Pesaro	Italy
Alexandra Hospital	Athens	Greece
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
General University Hospital Of Patras	Patras	Greece
Hospital Universitario Lucus Augusti	Lugo	Spain
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.	Peschiera Del Garda	Italy
Azienda Unita Sanitaria Locale Toscana Nord Ovest	Lucca	Italy
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Med Polonia Sp. z o.o.	Poznan	Poland
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Santa Maria Della Misericordia	Perugia	Italy
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Instytut Msf Sp. z o.o.	Lodz	Poland
Henry Dunant Hospital Center	Athens	Greece
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Beaumont Hospital	Dublin	Ireland
Centre Francois Baclesse	Caen	France
Universitaetsklinikum Giessen und Marburg GmbH	Giessen	Germany
Hxazxzjf Dt Lz Sbqkm Cbdr I Sfyk Pex	Barcelona	Spain
Atmujxakiv Pkyuixxz Hxejckfo Dc Mbfnjbsbs	Marseille	France
Ahrjcvd Oxffjxasepi Unqyzrnfdreut Ssfjtb	Siena	Italy
Ialsog Iftgeref Fipmzmmewygmt Omywocdfpoa	Rome	Italy
Hmknkorx Untjpbyhwatoh Dw Bgozpnj	Badajoz	Spain
Cmdfmnnc Hzkjmjgdogwm Ukonznwiwuuhe Dp Vodp	Vigo	Spain
Harcerdw Umoixyzunubcn Hfwgkjbl Tttca y Paofmj Iewlvevi Cqokso dalbiosldomdcuwva (oprl	Badalona	Spain
Hzfizqsq Vtxp drakoenr	Barcelona	Spain
Irrdyxra Cbivv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	26.01.2024
Germany	Not yet recruiting	26.01.2024
Greece	Not yet recruiting	26.01.2024
Ireland	Not yet recruiting	26.01.2024
Italy	Not yet recruiting	26.01.2024
Poland	Not yet recruiting	26.01.2024
Spain	Not yet recruiting	26.01.2024

Trial locations

Investigated drugs:

Ivonescimab is an experimental medication being tested in this clinical trial. It is being studied to see if it can help treat a type of lung cancer called metastatic squamous non-small cell lung cancer. In this trial, ivonescimab is combined with chemotherapy drugs to see if it can improve the survival of patients compared to another treatment option.

Pembrolizumab is a medication that helps the immune system fight cancer. It is already used to treat various types of cancer, including lung cancer. In this trial, pembrolizumab is combined with chemotherapy to see how well it works compared to the new medication, ivonescimab, when both are used as first-line treatments for metastatic squamous non-small cell lung cancer.

Carboplatin is a chemotherapy drug used to treat different types of cancer, including lung cancer. It works by stopping cancer cells from growing and dividing. In this trial, carboplatin is used in combination with other medications to see if it can help improve the treatment of metastatic squamous non-small cell lung cancer.

Paclitaxel is another chemotherapy drug used to treat various cancers, including lung cancer. It works by interfering with the normal function of microtubules during cell division, which helps stop the growth of cancer cells. In this study, paclitaxel is combined with other treatments to evaluate its effectiveness in treating metastatic squamous non-small cell lung cancer.

Nab-paclitaxel is a form of the chemotherapy drug paclitaxel that is bound to a protein called albumin. This formulation can help deliver the drug more effectively to cancer cells. In this trial, nab-paclitaxel is used alongside other medications to see if it can improve outcomes for patients with metastatic squamous non-small cell lung cancer.

Investigated diseases:

Non-small cell lung cancer metastatic

Metastatic Squamous Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the squamous cells, which are flat cells that line the inside of the airways in the lungs. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The term “metastatic” indicates that the cancer has spread from the lungs to other parts of the body. As the disease progresses, it can invade nearby tissues and organs, leading to a variety of symptoms depending on the areas affected. The cancer cells can travel through the bloodstream or lymphatic system to form new tumors in other organs. This spread can complicate the disease and affect the overall function of the body.

Trial ID:

2023-504989-37-00

Protocol code:

SMT112-3003

NCT ID:

NCT05899608

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ivonescimab and Chemotherapy with Pembrolizumab and Chemotherapy for Patients with Metastatic Squamous Non-small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?