Study Comparing Sacituzumab Govitecan and Docetaxel for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer After Previous Treatments

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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). The study is comparing two treatments for patients with advanced or metastatic NSCLC who have experienced progression after receiving certain previous treatments. The two treatments being compared are Sacituzumab Govitecan and Docetaxel. Sacituzumab Govitecan is a type of medication known as an antibody drug conjugate, which is designed to target and kill cancer cells. Docetaxel is a chemotherapy drug that works by stopping cancer cells from growing and dividing.

The purpose of this study is to compare the overall survival of patients receiving Sacituzumab Govitecan versus those receiving Docetaxel. Patients participating in the study will be randomly assigned to receive one of these two treatments. The study will be conducted over a period of time, with patients receiving their assigned treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor patients to see how long they live after starting the treatment and will also look at other factors such as the progression of the disease and any side effects experienced.

This study is open-label, meaning both the patients and the researchers know which treatment is being administered. It is a global, multicenter study, which means it is being conducted in multiple locations around the world. The study aims to provide valuable information on the effectiveness and safety of Sacituzumab Govitecan compared to Docetaxel in treating advanced or metastatic NSCLC.

1 randomization

Upon joining the study, you will be randomly assigned to receive either sacituzumab govitecan or docetaxel. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

2 treatment administration

If assigned to sacituzumab govitecan, you will receive it as a solution for infusion through a vein (intravenous use). The dosage is 200 mg, and it will be administered on specific days as determined by the study protocol.

If assigned to docetaxel, you will receive it as a concentrate for solution for infusion through a vein (intravenous use). The dosage is 20 mg/1 ml, and it will be administered on specific days as determined by the study protocol.

3 monitoring and assessments

Throughout the study, regular monitoring will occur to assess your health and the effectiveness of the treatment. This includes imaging tests like CT or MRI scans to measure the disease’s response to treatment.

Your health will be evaluated using various criteria, including the Eastern Cooperative Oncology Group (ECOG) performance status, which measures your ability to perform daily activities.

4 follow-up

After completing the treatment phase, follow-up visits will be scheduled to continue monitoring your health and any long-term effects of the treatment.

The study aims to compare overall survival (OS) between the two treatment groups, which is the time from randomization until death from any cause.

Who Can Join the Study?

Patients must have non-small cell lung cancer (NSCLC) that is at Stage 4, which means the cancer has spread to other parts of the body.
Patients must be 18 years of age or older and able to understand and give written consent to participate in the study.
Patients must have a life expectancy of 3 months or more.
Patients must have adequate liver function, which means their liver is working well enough. This is checked by measuring certain substances in the blood, like bilirubin and liver enzymes.
Patients must have a creatinine clearance of at least 30 mL/min. This is a measure of how well the kidneys are working.
Patients must have adequate blood counts without needing blood transfusions or growth factor support within 2 weeks before starting the study drug. This includes having enough red blood cells, white blood cells, and platelets.
Patients must have measurable disease based on imaging tests like CT or MRI scans. This means the cancer can be seen and measured on these scans.
Patients must have an ECOG performance status score of 0 or 1. This is a scale that measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Patients must have progressed after certain treatments. This means their cancer got worse after receiving specific therapies, such as platinum-based chemotherapy combined with anti-PD-1/PD-L1 antibody treatments.
Patients must have results for EGFR, ALK, and PD-L1 tests before joining the study. These are tests that look for specific changes in the cancer cells that might affect treatment options.
Male and female patients who can have children must agree to use specific methods of contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients with a different type of cancer other than non-small cell lung cancer cannot participate. This type of cancer affects the lungs and is not the same as small cell lung cancer.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be eligible. This term refers to groups who might need special protection or care, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Haemato-Onkologie Hamburg – Prof. Laack und Partner	Hamburg	Germany
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Hospital Foch	Suresnes	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Asklepios Klinik Gauting GmbH	Gauting	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Henry Dunant Hospital Center	Athens	Greece
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Champalimaud Clinical Centre	Lisbon	Portugal
Hopital Ambroise Pare	Boulogne-Billancourt	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Medical Center Haaglanden	Leidschendam	The Netherlands
Centre Hospitalier Lyon Sud	Pierre Benite	France
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Institut Sainte Catherine	Avignon	France
Clinique Victor Hugo	Le Mans	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Idqbrcdc Cdgamz Dlzkmqopkmfanjvve	L'hospitalet De Llobregat	Spain
Elmnaey Utzttkqxrioz Mslxdmw Cmukxip Roxmudpjb (apvcipy Mea	Rotterdam	The Netherlands
Axugbn Mcpxrgc Cwrvyo Soeu	Thessaloniki	Greece
Uhhzjxlvnt Oj Aivukra	Edegem	Belgium
Hjuzmkth Unrbngnotaapy dq A Cynhjp	A Coruna Galicia	Spain
Ipmonrgo Cmzca	Paris	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.02.2022
Belgium	Not recruiting	18.02.2022
France	Not recruiting	18.02.2022
Germany	Not recruiting	18.02.2022
Greece	Not recruiting	18.02.2022
Italy	Not recruiting	18.02.2022
Poland	Not recruiting	18.02.2022
Portugal	Not recruiting	18.02.2022
Spain	Not recruiting	18.02.2022
The Netherlands	Not recruiting	18.02.2022

Trial locations

Investigated drugs:

Sacituzumab Govitecan is a medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer. It is designed to target and deliver chemotherapy directly to cancer cells, potentially reducing the growth of tumors and improving patient outcomes.

Docetaxel is a chemotherapy drug commonly used to treat various types of cancer, including lung cancer. It works by interfering with the growth and division of cancer cells, which may help to slow down or stop the progression of the disease.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. The progression can vary significantly depending on the subtype and stage at diagnosis.

Trial ID:

2024-512148-50-00

Protocol code:

GS-US-577-6153

NCT ID:

NCT05089734

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Sacituzumab Govitecan and Docetaxel for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer After Previous Treatments

What is this study about?

Who Can Join the Study?

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