Study to Compare Datopotamab Deruxtecan with Rilvegostomig or Alone Against Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with High PD-L1 Levels

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What is this study about?

This clinical trial is focused on studying treatments for a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC). This specific form of lung cancer is characterized by high levels of a protein called PD-L1. The study will explore the effectiveness and safety of a new treatment combination involving two medications: Datopotamab deruxtecan (also known as Dato-DXd) and Rilvegostomig (also known as AZD2936). Additionally, the study will compare these treatments to another medication called Pembrolizumab, which is already used in treating this type of cancer.

The purpose of the study is to determine if the combination of Dato-DXd and Rilvegostomig, or Rilvegostomig alone, is more effective than Pembrolizumab in treating patients with advanced NSCLC. Participants in the study will receive one of these treatments, and some may receive a placebo. The study will monitor the progress of the disease and the overall health of the participants over time. The treatments will be administered through an intravenous infusion, which means they will be given directly into a vein.

Throughout the study, participants will have regular check-ups to assess their response to the treatment and to monitor any side effects. The study aims to provide valuable information on how these treatments can help manage NSCLC and improve the quality of life for those affected by this condition. The trial is expected to continue for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments being studied.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of non-squamous non-small cell lung cancer (NSCLC) with high PD-L1 expression.

A tumor sample is required to determine PD-L1 and TROP2 status, along with other biomarkers.

2 treatment assignment

Participants are randomly assigned to one of the treatment groups: either datopotamab deruxtecan with rilvegostomig, rilvegostomig alone, or pembrolizumab alone.

The assignment is open-label, meaning both the participant and the research team know which treatment is being administered.

3 treatment administration

For those receiving datopotamab deruxtecan and rilvegostomig, both medications are administered intravenously as a solution for infusion.

Participants receiving pembrolizumab also receive it intravenously as a solution for infusion.

The frequency and duration of administration are determined by the study protocol and the participant’s response to treatment.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the participant’s overall health.

Assessments include imaging tests to evaluate tumor response and blood tests to monitor organ function and bone marrow reserve.

5 follow-up

Participants continue to be monitored for progression-free survival (PFS) and overall survival (OS).

Additional assessments include the evaluation of lung cancer symptoms, quality of life, and any side effects experienced during the trial.

Who Can Join the Study?

  • The patient must have a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), which has been confirmed through specific tests.
  • The cancer must be at an advanced stage, specifically Stage IIIB, IIIC, or Stage IV, meaning it has spread and cannot be treated with surgery or combined treatments like chemotherapy and radiation.
  • The patient should not have certain genetic changes in their cancer, such as EGFR mutations or changes in ALK and ROS1 genes, which are known to have specific treatments available.
  • The patient must provide a sample of their tumor to check for specific markers, including PD-L1 and TROP2, which are proteins that can be found on cancer cells.
  • The patient’s tumor must show a high level of PD-L1 expression, which is a measure of how much of this protein is present, using a specific test called the VENTANA PD-L1 (SP263) Assay.
  • There must be at least one area of cancer that has not been treated with radiation and can be measured for changes during the study.
  • The patient should have a good general health status, as measured by the ECOG performance status, which should be 0 or 1. This means the patient is fully active or has some symptoms but can still carry out light work.
  • The patient must have enough healthy blood cells and properly working organs, as confirmed by tests done within 7 days before starting the study treatment.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not the specific type being studied.
  • Patients who have certain genetic changes in their cancer that can be targeted by specific treatments.
  • Patients who have received certain treatments for their cancer in the past that might affect the study results.
  • Patients with serious health conditions that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with active infections that require treatment.
  • Patients with certain heart conditions that could be worsened by the study treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Koranyi National Institute For Pulmonology Budapest Hungary
Hospital Jerez de la Frontera Jerez De La Frontera Spain
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Klinikum Nuernberg Nürnberg Germany
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Institut Jules Bordet Anderlecht Belgium
Onkodok GmbH Guetersloh Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital Del Mar Barcelona Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Institut Fuer Versorgungsforschung In Der Onkologie GbR Koblenz Germany
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Universitaetsklinikum Krems Krems An Der Donau Austria
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Katholisches Marienkrankenhaus gGmbH Hamburg Germany
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
Matrai Gyogyintezet Gyongyos Hungary
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
IRCCS Ospedale Policlinico San Martino Genoa Italy
Kaiserswerther Diakonie Duesseldorf Germany
Kepler Universitaetsklinikum GmbH Linz Austria
Jessa Ziekenhuis Hasselt Belgium
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
CHC MontLegia Liege Belgium
Salut Sant Joan De Reus Reus Spain
Muenchen Klinik gGmbH Munich Germany
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
CHU Helora La Louviere Belgium
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Gemeinschaftspraxis Für Hämatologie And Onkologie Langen Germany
Hämato-Onkologie Hamburg Hamburg Germany
Presidio Ospedaliero Humanitas Gavazzeni Bergamo Italy
Nnretjgm Iboszonmx Ok Tfrxrjckcece Aax Lnws Dmmzztny Warsaw Poland
Mep fxix Hadqxoxqaugg utf Otrariiex Kkxjf Ac Sukejtxjtdd Gssg Cologne Germany
Vwzdhvui Ngluizrv fbjf Gslyvdrqbc Ghte Berlin Germany
Bcatycbxbjy Vpfjlphsx Ohcvfyisachg Kecskemet Hungary
Gzwioonbciorupvmj Vcjadjktb Pqhd Axwfcv Eplbssbz Oehorj Kttifc Gyor Hungary
Nvbabeij Ieooaitf Onbmjgplr Igu Mtqxi Skshigllofmtjspkntfbyfonenyx Ikwhozpl Btdfeatn Cracow Poland
Ktybmlub Esbwaprgbrnyzunubnqblieo Hohyzqaeyumpyxsgl Essen Germany
Hygpyumq Dl Lu Seoco Cqmq I Sfzn Psn Barcelona Spain
Wahxwpcmsz Sbshcqg Idj Sfbpyve Pat W Pnnqbfypw Przemysl Poland
Jkswfanylx Gork Juuakquoygzbmfadyapxmn Bonn Germany

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
07.03.2025
Belgium Belgium
Recruiting
07.03.2025
Germany Germany
Recruiting
07.03.2025
Hungary Hungary
Recruiting
07.03.2025
Italy Italy
Recruiting
07.03.2025
Poland Poland
Recruiting
07.03.2025
Spain Spain
Recruiting
07.03.2025

Trial locations

Datopotamab Deruxtecan (Dato-DXd) is an investigational drug being studied for its potential to treat certain types of lung cancer. It is designed to target and deliver chemotherapy directly to cancer cells, which may help to reduce the growth of tumors.

Rilvegostomig (AZD2936) is another investigational medication in this trial. It is being tested both on its own and in combination with Dato-DXd to see if it can improve outcomes for patients with specific types of lung cancer.

Pembrolizumab is an approved medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being used as a comparison to evaluate the effectiveness of the new investigational treatments.

Investigated diseases:

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, which can form tumors. NSCLC is often diagnosed at an advanced stage, where it may have spread beyond the lungs. The disease progresses as cancer cells invade nearby tissues and potentially metastasize to other parts of the body. In cases with high PD-L1 expression, the cancer cells may evade the immune system more effectively. This type of NSCLC does not have specific genetic mutations that can be targeted with certain therapies.

Trial ID:
2023-505077-32-00
Protocol code:
D7632C00001
NCT ID:
NCT06357533
Trial Phase:
Therapeutic confirmatory (Phase III)

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