Study Comparing Ceralasertib and Durvalumab with Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Previous Treatments

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What is this study about?

This clinical trial is focused on studying treatments for advanced or metastatic non-small cell lung cancer, a type of lung cancer that has spread beyond the lungs. The study is comparing two different treatment options for patients whose cancer has progressed after previous treatments. One option is a combination of two medications: ceralasertib and durvalumab. Ceralasertib, also known by its code name AZD6738, is a medication taken orally in the form of a film-coated tablet. Durvalumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The other treatment option being studied is docetaxel, a medication also given as an infusion.

The purpose of this study is to determine if the combination of ceralasertib and durvalumab is more effective than docetaxel in treating patients with this type of lung cancer. Participants in the study will be randomly assigned to receive either the combination therapy or docetaxel. The study will monitor the overall survival of participants, which refers to the length of time patients live after starting the treatment. Other aspects being evaluated include how long the cancer stays under control, the quality of life reported by participants, and the safety and tolerability of the treatments.

The study will take place over a period of time, with participants receiving treatment for up to 24 months. During this time, participants will have regular check-ups and assessments to monitor their health and the progress of their cancer. The study aims to provide valuable information on the effectiveness and safety of these treatments for patients with advanced or metastatic non-small cell lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

A negative pregnancy test is required for women of childbearing potential.

Documentation of advanced or metastatic non-small cell lung cancer (NSCLC) is necessary.

2 randomization

Participants are randomly assigned to one of two treatment groups: ceralasertib plus durvalumab or docetaxel.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment with ceralasertib plus durvalumab

If assigned to this group, ceralasertib is taken orally in the form of film-coated tablets.

Durvalumab is administered intravenously as a solution for infusion.

The treatment schedule and dosage are determined by the study protocol and medical team.

4 treatment with docetaxel

If assigned to this group, docetaxel is administered intravenously as a solution for infusion.

The treatment schedule and dosage are determined by the study protocol and medical team.

5 monitoring and assessments

Regular monitoring of health status and response to treatment is conducted.

Assessments include physical examinations, imaging tests, and laboratory tests.

Participant-reported outcomes such as quality of life and physical functioning are also evaluated.

6 end of treatment

The treatment phase concludes as per the study protocol or if the participant decides to withdraw.

Final assessments are conducted to evaluate the overall response to the treatment.

7 follow-up

Participants enter a follow-up phase to monitor long-term health outcomes.

This phase includes periodic health assessments and may continue for a specified duration after the treatment ends.

Who Can Join the Study?

  • Participant must be at least 18 years old at the time of screening.
  • Women of childbearing potential must have a negative pregnancy test. This means a test to confirm they are not pregnant.
  • Must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is either advanced or has spread to other parts of the body.
  • Must not have certain genetic changes in their cancer, specifically EGFR and ALK wild-type status, which means these genes are normal and not mutated.
  • Must have evidence of cancer progression, meaning the cancer has grown or spread, after the most recent treatment.
  • Eligible for second- or third-line therapy, meaning they have already tried one or two other treatments. They must have received a specific type of treatment called anti-PD-(L)1 therapy and a treatment that includes platinum, either separately or together.
  • Must have a performance status of 0 or 1 on the ECOG/WHO scale, which means they are fully active or have some symptoms but can still do light work.
  • Must have adequate organ function and enough healthy blood cells.
  • Must have a minimum life expectancy of 12 weeks, meaning they are expected to live at least 12 more weeks.
  • Must weigh more than 30 kg (about 66 pounds) and not have severe weight loss due to cancer, known as cancer-associated cachexia.

Who Cannot Join the Study?

  • Patients who have not received second- or third-line therapy for their lung cancer.
  • Patients with lung cancer that has specific genetic changes that can be targeted by other treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Medisprof S.R.L. Cluj Napoca Romania
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Centre Jean Perrin Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
Koranyi National Institute For Pulmonology Budapest Hungary
Centre Hospitalier Intercommunal Creteil Creteil France
Hospital Clinico San Carlos Madrid Spain
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Cracow Poland
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
University Hospital Limerick Limerick Ireland
Grand Hopital De Charleroi Charleroi Belgium
Oncolab S.R.L. Craiova Romania
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Centre De Cancerologue Du Grand Montpellier Montpellier France
Radiotherapy Center Cluj S.R.L. Floresti Romania
Hopital De Libramont Libramont-Chevigny Belgium
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
Pelican Impex S.R.L. Oradea Romania
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
HIA Sainte Anne Toulon France
Med Polonia Sp. z o.o. Poznan Poland
Universita’ Campus Bio-medico Di Roma Rome Italy
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Vincentius-Diakonissen-Kliniken gAG Karlsruhe Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Hospital Universitario Virgen De Valme Sevilla Spain
Oncomed S.R.L. Timisoara Romania
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hopitaux Prives De Metz Vantoux France
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Centre Hospitalier De Saint-Quentin Saint Quentin France
St Vincent’s University Hospital Dublin Ireland
Gelre Hospitals Zutphen The Netherlands
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Beaumont Hospital Dublin Ireland
Centro Oncologico De Galicia A Coruna Galicia Spain
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Swyxzled Ksxsyosnkwg Brfhxfnyw Fzki Dyr Goitesralr Miojj Moers Germany
Ghvj Mbyncdg Svpbyq Bucharest Romania
Asrzuxv Odidbhbtgwu Ufqsfbgibhnnn Pkesx Parma Italy
Cttmru Lmdt Btjysy Lyon France
Iyepgd Iroyrcac Favyicxaqbmwh Ortiutygsce Rome Italy
Inthwewj Cfqdmv Dmrhgoibbgsrcnehm L'hospitalet De Llobregat Spain
Pdfk Tsbvz Hhmtbtzw Upbtniqagqqu Sabadell Spain
Itxwmaox Rzsmsehgz Prh Lx Slszzv Dpq Tpgrvl Dgwu Aeslvty Ilpi Slozlx Meldola Italy
Sjs Elhotksxb Htlfvuxp Tjazbtr Tilburg The Netherlands
Ufbtpagkxngewo Csllkes Kbndlprmp Gdansk Poland
Hqpyjjtq De Lk Sdgvh Cxzf I Shlc Pvo Barcelona Spain
Cfxd Ualidokvrt Hizfrbao Cork Ireland
Coyjid Haiikhhcsvh Rznfotha Djzkespulbkzfi Angers France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.08.2022
France France
Not recruiting
11.08.2022
Germany Germany
Not recruiting
11.08.2022
Hungary Hungary
Not recruiting
11.08.2022
Ireland Ireland
Not recruiting
11.08.2022
Italy Italy
Not recruiting
11.08.2022
Poland Poland
Not recruiting
11.08.2022
Romania Romania
Not recruiting
11.08.2022
Spain Spain
Not recruiting
11.08.2022
The Netherlands The Netherlands
Not recruiting
11.08.2022

Trial locations

Ceralasertib is a medication being studied for its potential to help treat advanced non-small cell lung cancer. It is being tested in combination with another drug to see if it can improve outcomes for patients whose cancer has progressed after previous treatments.

Durvalumab is an immunotherapy drug that helps the body’s immune system attack cancer cells. It is being used in combination with ceralasertib to see if this combination can be more effective in treating advanced non-small cell lung cancer.

Docetaxel is a chemotherapy drug that is commonly used to treat various types of cancer, including lung cancer. In this study, it is being used as a comparison to evaluate the effectiveness of the ceralasertib and durvalumab combination.

Advanced or Metastatic Non-Small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its spread beyond the lungs to other parts of the body. It is the most common form of lung cancer, accounting for a significant majority of cases. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. In its advanced or metastatic stage, the cancer has spread to distant parts of the body, such as the bones, brain, or liver. This progression can lead to a variety of symptoms, including persistent cough, chest pain, and difficulty breathing. The disease’s advancement is often marked by the cancer’s resistance to initial treatments, necessitating further therapeutic strategies.

Trial ID:
2023-509429-37-00
Protocol code:
D533BC00001
NCT ID:
NCT05450692
Trial Phase:
Therapeutic confirmatory (Phase III)

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