Study of Atezolizumab and Tiragolumab Compared to Durvalumab for Patients with Advanced Non-Small Cell Lung Cancer After Chemoradiation

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study is investigating the effectiveness of two treatments: atezolizumab and tiragolumab, compared to another treatment called durvalumab. Atezolizumab is also known by its code name RO5541267, and durvalumab is known as MEDI4736. These treatments are given as solutions through an intravenous (IV) infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well the combination of atezolizumab and tiragolumab works compared to durvalumab in patients with locally advanced, unresectable stage III NSCLC. “Unresectable” means that the cancer cannot be removed with surgery. The study will look at how long patients live without the cancer getting worse, which is known as progression-free survival. This will be assessed by an independent review facility, which is a group of experts who will review the results.

Participants in the study will receive their assigned treatment for up to 52 weeks. The study will monitor the patients’ health and the progression of their cancer during this time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information on the best treatment options for patients with this type of lung cancer.

1 joining the study

Upon joining the study, the patient is confirmed to have non-small cell lung cancer (NSCLC) that is locally advanced and cannot be removed by surgery.

The patient must have completed at least two cycles of platinum-based chemotherapy with radiotherapy, with no disease progression during or after this treatment.

2 randomization

The patient is randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

3 treatment administration

The patient receives treatment through an intravenous (IV) infusion. The specific medications used are either a combination of atezolizumab and tiragolumab or durvalumab alone.

Atezolizumab is administered as Tecentriq 840 mg concentrate for solution for infusion.

Durvalumab is administered as IMFINZI 50 mg/mL concentrate for solution for infusion.

Tiragolumab is administered as a concentrate for solution for infusion.

4 monitoring and follow-up

The patient’s health and response to the treatment are regularly monitored. This includes assessments of disease progression and any side effects experienced.

Progression-free survival (PFS) is evaluated, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

5 end of study participation

The study is estimated to conclude by December 31, 2027. The patient’s participation may end earlier if the disease progresses or if the patient experiences significant side effects.

Who Can Join the Study?

  • The patient must have non-small cell lung cancer (NSCLC), which is a type of lung cancer.
  • The patient should have an Eastern Cooperative Oncology Group Performance Status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must have NSCLC that is locally advanced and cannot be removed by surgery, either of squamous or non-squamous type, confirmed by a tissue sample.
  • A whole-body PET-CT scan must be done for staging the cancer, within 42 days before starting the combined treatment of chemotherapy and radiotherapy.
  • The patient must have completed at least two cycles of platinum-based chemotherapy given at the same time as radiotherapy, finished between 1 to 42 days before joining the study. One cycle lasts 21 or 28 days.
  • The radiotherapy part of the treatment must have been given at a total dose of 60 Gy, with a possible variation of 10% (54 Gy to 66 Gy), using a method called intensity-modulated radiotherapy or a 3D-conforming technique.
  • The patient should not have experienced any worsening of the cancer during or after the combined treatment of chemotherapy and radiotherapy.
  • Both male and female patients can participate.
  • The study includes patients who might be considered vulnerable.

Who Cannot Join the Study?

  • Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who have previously received certain treatments that might interfere with the study drugs are not eligible.
  • Patients with serious heart conditions or uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, such as hepatitis or HIV, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to similar drugs are not eligible.
  • Patients with autoimmune diseases, where the immune system attacks the body, are excluded.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers, cannot join.
  • Patients with brain metastases, which are cancer cells that have spread to the brain, are not eligible unless treated and stable.
  • Patients who are unable to follow the study procedures or attend regular visits are excluded.

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
Institut Gustave Roussy Villejuif France
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Az Maria Middelares Gent Gent Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Azienda Unita Locale Socio Sanitaria N 8 Berica Vicenza Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Grand Hopital De Charleroi Charleroi Belgium
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. Coimbra Portugal
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie Olsztyn Poland
Hopitaux Prives De Metz Vantoux France
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Da Luz S.A. Lisbon Portugal
Meander Medical Center Amersfoort The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Hospital Son Llatzer Palma Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Jessa Ziekenhuis Hasselt Belgium
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital General Universitario De Castellon Castello De La Plana Spain
Medical Center Haaglanden Leidschendam The Netherlands
Muenchen Klinik gGmbH Munich Germany
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
University Of Pecs Pecs Hungary
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Universita Degli Studi Di Brescia Brescia Italy
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Centre De Cancerologue Du Grand Montpellier Montpellier France
Centre Francois Baclesse Caen France
Hospital CUF Porto S.A. Porto Portugal
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Otwock Poland
Ajgqogt Obupyahvgrt Upxfdkbknmgxh Pnzfq Parma Italy
Iwqsil Inxqgrgb Feosinjyqrutu Opgitytnsgy Rome Italy
Dgvuudkdqkpr Cgjdcgr Ouqpokcjd Phattzdboerl I Hmtigdktbpt Wroclaw Poland
Lnrxn Gzssiit Hqxdvdib Oj Ajgilx Athens Greece
Ibbwcfqh Rvxfovzrm Pwz Ln Sqiudf Dqu Tdjxwf Depy Aovrctt Icut Smmlbs Meldola Italy
Aigrzjmlgf Pdrygazu Hwucnsat Dq Mqqvoqzpq Marseille France
Nnfkdisb Iyxyzlha Onimktnzl Ici Myjil Swrkodogjusrlcnndyuzdskcduwx Iorjasgt Bdvwwftv Cracow Poland
Ufzvkoqqdlluor Cqhlawm Kfyntrsyy Gdansk Poland
Ircdqdhq Cyvudu Dhdubaceihxymwffr L'hospitalet De Llobregat Spain
Cznhif Hjziueehxzh Rjqazwkt Dwafwcuwspizvg Angers France
Fjxqbxajf Pfsi Li Inzwxkiiftlvd Bshfmsglt Dzx Hqptfvcs Uapqkpzolerjo Lh Pth Madrid Spain
Jyubydcx Kbkprs Uacojrbttv Linz Austria
Hussacyg Vltp dmxwcrpe Barcelona Spain
Hshevxlw Uxfjhiaqkdpqn dh A Clkfdw A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
12.10.2020
Belgium Belgium
Not recruiting
12.10.2020
France France
Not recruiting
12.10.2020
Germany Germany
Not recruiting
12.10.2020
Greece Greece
Not recruiting
12.10.2020
Hungary Hungary
Not recruiting
12.10.2020
Italy Italy
Not recruiting
12.10.2020
Poland Poland
Not recruiting
12.10.2020
Portugal Portugal
Not recruiting
12.10.2020
Spain Spain
Not recruiting
12.10.2020
The Netherlands The Netherlands
Not recruiting
12.10.2020

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the body to better target and destroy them.

Tiragolumab is another medication being tested in combination with atezolizumab. It is designed to enhance the immune response against cancer cells by targeting a specific protein that can inhibit immune activity, potentially improving the effectiveness of cancer treatment.

Durvalumab is a medication used as a comparison in this study. It also helps the immune system attack cancer cells by blocking a protein that prevents the immune system from working properly. This medication is used to see how well it works compared to the combination of atezolizumab and tiragolumab.

Non-small cell lung cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:
2022-502480-38-00
Protocol code:
GO41854
Trial Phase:
Therapeutic confirmatory (Phase III)

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