Study Comparing Ociperlimab and Tislelizumab with Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for non-small cell lung cancer, a type of lung cancer that is locally advanced, cannot be surgically removed, or has spread to other parts of the body. The study involves three different treatments: Ociperlimab, an anti-TIGIT antibody, used in combination with Tislelizumab, and a comparison with Pembrolizumab, which is followed by a placebo. The purpose of the study is to compare the overall survival of patients receiving these treatments.

Participants in the study will be randomly assigned to one of two groups. One group will receive Ociperlimab in combination with Tislelizumab, while the other group will receive Pembrolizumab followed by a placebo. The treatments are given as infusions, which means they are administered directly into the bloodstream through a vein. The study will monitor the participants over a period of time to assess the effectiveness of the treatments in improving survival rates.

The trial aims to provide valuable information on how these treatments can help patients with non-small cell lung cancer. By comparing the different treatment options, researchers hope to find the most effective approach for managing this type of cancer. The study will also look at the quality of life of participants and any side effects they may experience during the trial.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups: Arm A or Arm B. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

2 treatment administration – arm a

If assigned to Arm A, you will receive a combination of ociperlimab and tislelizumab. Both medications are administered as an infusion, which means they are given directly into your bloodstream through a vein.

The specific dosage and frequency of these infusions will be determined by the study protocol and your healthcare provider.

3 treatment administration – arm b

If assigned to Arm B, you will receive pembrolizumab followed by a placebo. Pembrolizumab is also administered as an infusion.

The placebo is a substance with no active medication, used to compare the effects of pembrolizumab. The dosage and frequency will be specified by the study protocol.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your health and the effects of the treatment.

These assessments may include physical exams, blood tests, imaging studies, and questionnaires about your quality of life.

5 end of treatment

The treatment phase will continue until the study’s end date or until it is determined that you should stop treatment for any reason, such as side effects or disease progression.

Your healthcare provider will discuss the next steps with you at the end of the treatment phase.

6 follow-up

After completing the treatment phase, follow-up visits will be scheduled to monitor your health and gather additional information about the long-term effects of the treatment.

These visits are an important part of the study to ensure your well-being and to collect data for the study’s objectives.

Who Can Join the Study?

  • Must be able to provide written consent and agree to follow the study requirements and schedule.
  • Must be at least 18 years old or the legal age of consent in the study location.
  • Must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced or has come back and cannot be treated with surgery or radiation to cure it.
  • Must not have had any previous treatment for NSCLC that has spread to other parts of the body.
  • Must agree to provide a sample of tumor tissue for testing.
  • The tumor must show a protein called PD-L1 in at least 50% of the cancer cells.
  • Must have at least one tumor that can be measured according to specific guidelines.
  • Must have a good level of daily functioning, as measured by a scale called ECOG Performance Status, with a score of 0 or 1.
  • Must have normal organ function based on specific blood tests, including:
    • Enough white blood cells, platelets, and hemoglobin without needing a blood transfusion or growth factor support in the last 14 days.
    • Normal kidney function, measured by serum creatinine levels or a calculation of kidney filtration rate.
    • Normal levels of bilirubin, a substance made by the liver, unless the patient has a condition called Gilbert’s syndrome.
    • Normal levels of liver enzymes called AST and ALT, unless there is cancer in the liver.
  • Women who can have children must use a reliable form of birth control during the study and for at least 120 days after the last dose of the study drug. They must also have a negative pregnancy test before starting the study.
  • Men who are not sterile must use a reliable form of birth control during the study and for at least 120 days after the last dose of the study drug. A sterile male is someone who has been proven to be unable to father children.

Who Cannot Join the Study?

  • Patients with other types of cancer besides the specific lung cancer being studied cannot participate.
  • Patients who have had previous treatments that might interfere with the study drugs are not eligible.
  • Patients with serious heart conditions or other major health issues that could affect their safety during the trial are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with known allergies to the study drugs or similar medications are excluded.
  • Patients who are participating in another clinical trial at the same time are not allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De La Reunion St Denis France
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
Isala Klinieken Stichting Zwolle The Netherlands
Asklepios Klinik Gauting GmbH Gauting Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital General Universitario Morales Meseguer Murcia Spain
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Hospital Universitario De Jaen Jaen Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Ziekenhuis St Jansdal Harderwijk The Netherlands
Azienda Ospedaliera Papardo Messina Italy
Med Polonia Sp. z o.o. Poznan Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospital Universitario Virgen De Valme Sevilla Spain
Centre Hospitalier De La Cote Basque Bayonne France
Hospital Universitario Lucus Augusti Lugo Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Muenchen Klinik gGmbH Munich Germany
Unite De Recherche Clinique HIA Begin Saint-Mande France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Servei De Salut De Les Illes Balears Palma Spain
Immobiliere De Nancy Nancy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
CHU De Martinique Fort De France France
Hospital Universitario Virgen De La Victoria Malaga Spain
Agaplesion Diakonieklinikum Rotenburg gGmbH Rotenburg Germany
Centre Hospitalier Universitaire de la Réunion – Site Sud Saint Pierre France
Itlnksdp Rpuwjztx Dw Celkmy Dz Moonrupjhwt Montpellier France
Wutdtmzlyds Wcjdipxeghfvtzuiajgc Cipxbey Owacdzgyn I Tojdgycfpznzh Ip Mgytbgostxj W Lzyzf Lodz Poland
Srdyqvmc Pmhpppjbg Stu z oiua Gdynia Poland
Otinsj Slvynbobmbhgqfafxge Ug (jsambfbefzgdiwetdjpb Schwetzingen Germany
Inngwrle Rwinrxsga Pyi Ls Sebpju Dyq Tupcjc Drkq Apsxkqg Ilai Sdawme Meldola Italy
Crgscb Hgasvzrojab Rgbqkkif Ubogilnuhbvyl Do Tpyww Tours France
Aeraxjb Uppue Silalsemh Ledaxl Db Bknnydx Bologna Italy
Hlqoxedu Da Ln Sdyrg Cvsm I Sxll Pml Barcelona Spain
Ipeughmm Cqellg Dijkswwadyiprbons L'hospitalet De Llobregat Spain
Ftzdmpves Pnuj Ls Ihzjtfdwmwhgp Blgaenluo Doe Hretbtbq Ubvtpumogczsf Lf Pnu Madrid Spain
Cho Cnwxg Rfegeqkkuye Lyon France
Hrtfirwf Vzet dxtazgtp Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
03.08.2021
Germany Germany
Not recruiting
03.08.2021
Italy Italy
Not recruiting
03.08.2021
Poland Poland
Not recruiting
03.08.2021
Spain Spain
Not recruiting
03.08.2021
The Netherlands The Netherlands
Not recruiting
03.08.2021

Trial locations

Ociperlimab is an experimental medication being studied for its potential to help the immune system fight cancer. It is an antibody that targets a specific protein called TIGIT, which can suppress the immune response. By blocking this protein, ociperlimab may enhance the body’s ability to attack cancer cells.

Tislelizumab is a medication that helps the immune system recognize and fight cancer cells. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer. Tislelizumab is used in combination with other treatments to improve the immune response against cancer.

Pembrolizumab is a medication that boosts the immune system’s ability to fight cancer. It targets the PD-1 protein on immune cells, helping them to detect and destroy cancer cells more effectively. Pembrolizumab is used in various types of cancer treatments to improve patient outcomes.

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 characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease is termed “locally advanced” when it has spread to nearby tissues or lymph nodes but not to distant body parts. “Unresectable” means that the cancer cannot be removed completely through surgery. “Metastatic” indicates that the cancer has spread to other parts of the body. The progression of this disease can vary, with some tumors growing slowly and others more rapidly.

Trial ID:
2023-507317-10-00
Protocol code:
BGB-A317-A1217-302
NCT ID:
NCT04746924
Trial Phase:
Therapeutic confirmatory (Phase III)

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