Study of Durvalumab with Radiation Therapy for Patients with Early Stage Non-Small Cell Lung Cancer and Osimertinib for Those with EGFR Mutation

1 1 1

What is this study about?

This clinical trial is focused on studying treatments for patients with early-stage non-small cell lung cancer (NSCLC), a type of lung cancer that is not small cell in nature. The study involves two main treatments. The first treatment is with a medication called durvalumab, also known by its code name MEDI4736, which is given alongside a type of radiation therapy called stereotactic body radiation therapy (SBRT). The second treatment involves a medication called osimertinib, also known as AZD9291, which is given after radiation therapy to patients whose cancer has a specific change in the EGFR gene, making it more sensitive to this treatment.

The purpose of the study is to evaluate how effective these treatments are in managing early-stage NSCLC. For the durvalumab group, the study will compare the effects of durvalumab combined with SBRT to a placebo combined with SBRT. For the osimertinib group, the study will assess the effects of osimertinib following SBRT in patients with an EGFR mutation. The study will follow participants over a period to observe the progression of the disease and overall survival rates.

Participants in the study will receive either the active treatment or a placebo, depending on the group they are in. The study will involve regular monitoring and assessments to track the progress of the disease and any side effects from the treatments. The study aims to provide valuable information on the effectiveness of these treatments in improving outcomes for patients with early-stage NSCLC.

1 joining the study

Upon joining the study, the patient will provide signed and dated written informed consent before any study-specific procedures, sampling, and analyses begin.

Eligibility criteria include being 18 years or older, having a confirmed diagnosis of Stage I/II non-small cell lung cancer (NSCLC), and planning to receive stereotactic body radiation therapy (SBRT) as definitive treatment.

2 initial assessments

Initial assessments will include staging studies such as a PET-CT scan within 10 weeks of screening.

Pulmonary function testing will be conducted within 16 weeks of randomization for the main cohort.

3 treatment phase for main cohort

Patients in the main cohort will receive durvalumab administered intravenously as a solution for infusion.

The treatment will be combined with standard of care (SoC) SBRT.

4 treatment phase for osimertinib cohort

Patients in the osimertinib cohort will receive osimertinib orally in the form of film-coated tablets.

This treatment follows the completion of SoC SBRT.

5 monitoring and follow-up

Throughout the study, patients will undergo regular monitoring, including laboratory studies, clinical evaluations, and electrocardiograms (ECG).

The study will assess progression-free survival (PFS) and overall survival (OS) as primary and secondary endpoints.

6 end of study

The estimated end date for the study is January 30, 2028.

Patients will continue to be monitored for safety and efficacy outcomes until the study concludes.

Who Can Join the Study?

  • You must provide a signed and dated written consent form before any study-specific procedures, sampling, and analyses.
  • You need to be at least 18 years old.
  • You should have Stage I or II Non-small Cell Lung Cancer (NSCLC) that is documented through a biopsy or cell sample. The cancer should be at a specific stage (T1 to T3N0M0) and planned to be treated with a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT).
  • You should be planned to receive SBRT as the main treatment.
  • Your overall health should be good enough to perform daily activities, as measured by a scale called the World Health Organization (WHO)/ECOG Performance Status, with a score of 0, 1, or 2.
  • You can have either central or peripheral lung lesions.
  • If you have had another type of lung cancer in the past or have multiple lung lesions at the same time, you may still be eligible, with some exceptions.
  • You must have certain tests done during the screening process, including a PET-CT scan within 10 weeks.
  • You need to submit available tumor tissue or cell samples from a procedure called Fine Needle Aspiration (FNA).
  • For the main cohort (durvalumab), you should have a life expectancy of at least 12 weeks.
  • For the main cohort (durvalumab), you should weigh more than 30 kg (about 66 pounds).
  • For the main cohort (durvalumab), your organs and bone marrow should be functioning well enough.
  • For the main cohort (durvalumab), you need to have a Pulmonary Function Test within 16 weeks of being assigned to a treatment group.
  • For the osimertinib cohort, your tumor must have one of the two common EGFR mutations that make it sensitive to a type of treatment called EGFR-TKI. These mutations are known as Ex19del or L858R.
  • For the osimertinib cohort, you should have enough bone marrow reserve or organ function.

Who Cannot Join the Study?

  • Patients who have had surgery to remove their lung cancer cannot participate.
  • Patients with lung cancer that has spread to the lymph nodes are not eligible.
  • Patients with lung cancer that has spread to other parts of the body are excluded.
  • Patients who do not have a specific type of genetic change in their cancer called a sensitizing EGFR mutation cannot join the osimertinib group. This mutation is a change in the DNA that can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach Katowice Poland
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centr Georges Francois Leclerc Dijon France
IRCCS Humanitas Research Hospital Rozzano Italy
Universitaetsmedizin Goettingen Goettingen Germany
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Universitair Ziekenhuis Gent Gent Belgium
Barmherzige Brueder Trier gGmbH Trier Germany
Klinikum Region Hannover GmbH Hanover Germany
Hospital Universitario 12 De Octubre Madrid Spain
Grand Hopital De Charleroi Charleroi Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Ziekenhuis St Jansdal Harderwijk The Netherlands
Henry Dunant Hospital Center Athens Greece
Hospital Clinico Universitario De Valencia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Campus Bio-medico Di Roma Rome Italy
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Saarland University Hospital Homburg Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
St. Luke’s Hospital S.A. Thessaloniki Greece
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Hopital Prive Clairval Marseille France
Centre Hospitalier Lyon Sud Pierre Benite France
L’Hopital Prive Du Confluent Nantes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Metropolitan Hospital Athens Greece
Uhznnpuvbwun Mfupjpy Cjhyrvc Gzmqveihr Groningen The Netherlands
Ioqincvn Cstbyf Dykidmqdrzdebsvjl L'hospitalet De Llobregat Spain
Hwmmhfeq Usbqhrqmgjdly Dm Bnwaaem Badajoz Spain
Wuwrvcuxchx Wquulfokhqfqpjakzhja Cfbodtr Oidwrhqcp I Tybthmqeajpxv Ib Mcrsechlgud W Lnqqc Lodz Poland
Ne Mzs Gmfzl Sgaz Elblag Poland
Ovxdpntfdywwoprzggfuosmkyp Aalst Belgium
Lkser Gfhedbk Hlrbibhj Og Arkowh Athens Greece
Agvndfwmr Uny Amsterdam The Netherlands
Higzqauv Uuovwimniyace Dctwjabl Donostia / San Sebastian Spain
Nysolkoi Ibgjcapa Omujtajqd Imj Mdipg Soyuyktdrwgfsndbeecwyviqhtxs Ipxdonrn Bocokhby Cracow Poland
Upvliucnbirwyn Cgxketm Kewewptoh Gdansk Poland
Hyvbcpkc Df Lu Syljm Cewh I Sspn Pfq Barcelona Spain
Unoqxwiqeh Ol Avitxyt Edegem Belgium
Ffleqzbax Pzwz Ld Iixagteywnrgm Bwiplntta Dmu Hidoglqw Uztppedwmybuu Lw Pwl Madrid Spain
Cry Cadwx Rwihhnmkqcn Lyon 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
25.04.2024
France France
Not recruiting
25.04.2024
Germany Germany
Not recruiting
25.04.2024
Greece Greece
Not recruiting
25.04.2024
Italy Italy
Not recruiting
25.04.2024
Poland Poland
Not recruiting
25.04.2024
Spain Spain
Not recruiting
25.04.2024
The Netherlands The Netherlands
Not recruiting
25.04.2024

Trial locations

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It is being tested in combination with a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) to see if it can improve outcomes for patients with certain types of lung cancer that cannot be removed by surgery.

Osimertinib is another medication being studied in this trial. It is used for patients with a specific genetic mutation in their lung cancer. The trial is testing if taking osimertinib after receiving SBRT can help prevent the cancer from coming back over a period of four years.

Non-small Cell Lung Cancer – Non-small Cell Lung Cancer (NSCLC) 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 tissues of the lung. NSCLC is often diagnosed at an advanced stage because early stages may not present noticeable symptoms. As the disease progresses, it can spread to other parts of the body, including lymph nodes and distant organs. The progression of NSCLC is typically categorized by stages, with Stage I and II indicating localized cancer without lymph node involvement. The presence of specific genetic mutations, such as EGFR mutations, can influence the behavior and progression of the disease.

Trial ID:
2024-512667-31-00
Protocol code:
D9103C00001
NCT ID:
NCT03833154
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Testing the Safety and Effects of TUB-030 in Patients with Advanced Head and Neck Cancer or Non-Small-Cell Lung Cancer

    Recruiting

    1 1
    Investigated drugs:
    France Romania Spain
  • Study of cemiplimab treatment after surgery in patients with stage II-IIIA non-small cell lung cancer who have not received chemotherapy and have PD-L1 expression of 1% or higher

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Estonia France Germany Ireland Italy +1