Efficacy of Cobolimab, Dostarlimab, and Docetaxel in Advanced Non-Small Cell Lung Cancer Post Anti-PD(L)1 Therapy and Chemotherapy

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What is this study about?

This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study involves three different treatment combinations. The first combination includes cobolimab, dostarlimab, and docetaxel. The second combination includes dostarlimab and docetaxel. The third treatment is docetaxel alone. Dostarlimab is also known by its code names WBP-285 and TSR-042, and cobolimab is referred to as GSK4069889A.

The purpose of the study is to compare the effectiveness of these treatment combinations in patients with advanced NSCLC who have previously been treated with other therapies. Participants will be randomly assigned to one of the three treatment groups. The treatments will be given as an infusion, which means they are administered directly into the bloodstream through a vein. The study will monitor the participants over a period to assess how well the treatments work and to observe any side effects.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with advanced Non-Small Cell Lung Cancer.

Who Can Join the Study?

You must be at least 18 years old (or 19 years old if you are in Korea) and be able to understand the study steps and sign a written agreement to participate.
You must have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), which means the cancer has spread or is at an advanced stage, and it must be specifically the squamous or nonsquamous type of cell.
You must have received no more than two previous treatments for your advanced cancer. These treatments must only consist of one type of platinum-based chemotherapy (a type of cancer medicine containing platinum, such as cisplatin or carboplatin) and one type of anti-PD-1 or anti-PD-L1 antibody (an immunotherapy drug that helps the immune system fight cancer).
You cannot have previously used targeted therapies, such as angiogenesis inhibitors (medicines that stop the growth of new blood vessels that feed tumors).
Your cancer must be measurable, meaning a doctor can clearly see and track at least one tumor lesion (an area of abnormal tissue or a tumor) using medical imaging like scans.
There must be evidence from medical imaging, such as a scan, that your cancer has progressed (grown or spread) after you received your previous platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 antibody therapy.
You must agree to provide a tumor tissue specimen (a sample of the cancer cells) that was collected after your cancer was diagnosed as being advanced or spread. If old samples are not available, you will need to have a biopsy (a procedure to remove a small piece of tissue for testing) before joining the study.

Who Cannot Join the Study?

You cannot participate if you previously took an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug (treatments that help the immune system fight cancer) and had to stop using them permanently because of an adverse event (a side effect or medical problem caused by the treatment).
You cannot participate if you had major surgery within 3 weeks before the first dose of the study treatment, or if you have not fully recovered from complications (unintended medical problems) or side effects from a previous surgery. Note that having a port catheter (a small tube placed under the skin to give medicine) surgically implanted does not prevent you from joining.
You cannot participate if you have brain metastases (cancer that has spread to the brain) or leptomeningeal metastases (cancer that has spread to the protective membranes covering the brain and spinal cord) that are new or growing. However, if your brain cancer is stable and you have been neurologically stable (your brain functions normally without sudden changes) for 4 weeks and are off corticosteroids (steroid medicines used to reduce swelling), you may be eligible.
You cannot participate if you test positive for Hepatitis B surface antigen (a sign of Hepatitis B infection) or if you test positive for Hepatitis C antibodies unless a follow-up RNA test (a test that looks for the actual virus in the blood) confirms you do not have an active infection.
You cannot participate if you have an active infection that requires systemic therapy (medicine that travels through the whole body, such as antibiotics) within 1 week of the first study dose.
You cannot participate if you have HIV (a virus that attacks the body’s immune system).
You cannot participate if you have another type of cancer, except for certain skin, bladder, or cervical cancers that were treated and show no signs of returning, or if a previous cancer was cured and has been gone for at least 5 years.
You cannot participate if you have previously been treated with anti-TIM-3, anti-CTLA-4, or docetaxel (a type of chemotherapy medicine).
You cannot participate if your cancer has specific driver mutations, which are genetic changes like EGFR, ALK, or ROS-1 that cause the cancer to grow. If your tumor has not been tested for these, you cannot join.
You cannot participate if your cancer showed disease progression (meaning the cancer grew or got worse) within 8 weeks after starting previous anti-PD-1 or anti-PD-L1 treatments.
You cannot participate if you received more than 30 Gy (a measurement of the amount of radiation) of radiation therapy to the lungs within the last 6 months.
You cannot participate if you had palliative radiotherapy (radiation intended to relieve pain or symptoms rather than cure the cancer) within 7 days of the first study dose.
You cannot participate if you have certain hepatic characteristics (signs of liver issues), such as high levels of ALT, AST, alkaline phosphatase, or bilirubin (substances measured in blood tests to check liver health), or if you have active liver or bile duct disease.
You cannot participate if your corrected QT interval (QTc) is too long. The QTc is a measurement of the time it takes for your heart muscle to recharge between beats, adjusted for your heart rate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Centre Hospitalier Intercommunal Creteil	Creteil	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Centre Antoine Lacassagne	Nice	France
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Oncolab S.R.L.	Craiova	Romania
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Medisch Spectrum Twente	Enschede	The Netherlands
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Ziekenhuis St Jansdal	Harderwijk	The Netherlands
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Henry Dunant Hospital Center	Athens	Greece
Ars Medical Sp. z o.o.	Pila	Poland
General University Hospital Of Larissa	Larissa	Greece
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Alexandra Hospital	Athens	Greece
Hospital Clinic De Barcelona	Barcelona	Spain
Karolinska University Hospital	Solna	Sweden
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Universita’ Politecnica Delle Marche	Ancona	Italy
Jessa Ziekenhuis	Hasselt	Belgium
Oncomed S.R.L.	Timisoara	Romania
General University Hospital Of Patras	Patras	Greece
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Centre Hospitalier Universitaire De Rennes	Rennes	France
Pohjois-Savon hyvinvointialue	Kuopio	Finland
Radiology Therapeutic Center S.R.L.	Otopeni	Romania
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Area De Salud De Burgos Y Soria	Burgos	Spain
Region Halland	Varberg	Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uyhtqnqboldn Mgqbwby Czmgmbo Gxiwjvqlk	Groningen	The Netherlands
Sbkmnrlm Pwhfiginj Sck z oyqr	Gdynia	Poland
Ossimtnbgeofxemzmjshbcmqqz	Aalst	Belgium
Llmrc Ggcwces Hlotaqnq Oi Avpqot	Athens	Greece
Andpboi Okrduboydps Uozsadxkjdkdy Srdwny	Siena	Italy
Chiegh Hqhnxwlfdss Rzsphjgm Uvexhggmmiwrm Dc Tyuic	Tours	France
Avppsh Mjqjetj Cynxei Sywu	Thessaloniki	Greece
Kyzqascs dtn Usmyltrtsfya Mujhkouo Arv	Munich	Germany
Ivfshcdf Cheseb Dwvfrehkyuhwhpehb	L'hospitalet De Llobregat	Spain
Fvvbvmloc Phhq Lp Ivkdajzvhrbne Bvxtgwvqv Dak Huyioyie Uubecqcpmkmyz Ln Pzz	Madrid	Spain
Hvnkmbms Vrar duawoobv	Barcelona	Spain
Ibumiaci Pfrimlnmxvgcqdo Ccsyvv Cajtcq	Marseille	France
Hynwushx Uupidozpcifqf dt A Cadbha	A Coruna Galicia	Spain
Ucespikmyd Gaqcdtg Hcjkrjlg Aotubql	Athens	Greece

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.02.2021
Finland	Not recruiting	01.02.2021
France	Not recruiting	01.02.2021
Germany	Not recruiting	01.02.2021
Greece	Not recruiting	01.02.2021
Italy	Not recruiting	01.02.2021
Poland	Not recruiting	01.02.2021
Romania	Not recruiting	01.02.2021
Spain	Not recruiting	01.02.2021
Sweden	Not recruiting	01.02.2021
The Netherlands	Not recruiting	01.02.2021

Trial locations

Investigated drugs:

Dostarlimab is a type of immunotherapy that helps the body’s own immune system recognize and attack cancer cells.

Cobolimab is an experimental therapy being tested to see if it can work alongside other treatments to improve the body’s immune response against cancer.

Docetaxel is a type of chemotherapy drug used to stop the growth of cancer cells.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung cancer – This is a type of cancer that begins in the cells of the lung. It is the most common form of lung cancer and involves cells that are not small or round. The disease typically starts in the lining of the airways and can spread to nearby lymph nodes or other parts of the body. As it progresses, the abnormal cells grow and multiply uncontrollably within the lung tissue.

Trial ID:

2023-507475-21-00

Protocol code:

213410

NCT ID:

NCT04655976

Trial Phase:

Therapeutic use (Phase IV)

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Efficacy of Cobolimab, Dostarlimab, and Docetaxel in Advanced Non-Small Cell Lung Cancer Post Anti-PD(L)1 Therapy and Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?