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Study on Alectinib and Durvalumab for Patients with Locally Advanced, Unresectable Stage III 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 (NSCLC), which is a type of lung cancer that is common and can be challenging to treat when it reaches an advanced stage. The study will explore the effectiveness and safety of different therapies for patients with locally advanced, unresectable Stage III NSCLC. The treatments being tested include Alecensa (also known by its code name RO5424802), which contains the active substance alectinib, and IMFINZI, which contains the active substance durvalumab. Another treatment option being evaluated is entrectinib, which is a type of medication known as a tyrosine kinase inhibitor.

The purpose of the study is to compare these treatments in patients who have specific biomarkers, which are unique characteristics found in their cancer cells. These patients have already received a combination of chemotherapy and radiation therapy, known as chemoradiotherapy, and have not shown any progression of their disease on imaging tests. The study will assess how well these treatments work in preventing the cancer from getting worse, which is referred to as progression-free survival.

Participants in the study will receive one of the treatments, and some may receive a placebo. The study will monitor the patients over a period of time to observe the effects of the treatments on their cancer and overall health. The trial aims to provide valuable information on the best treatment options for patients with this type of lung cancer, helping to improve future care and outcomes for those affected by NSCLC.

1 joining the study

Upon joining the study, participation begins with a comprehensive evaluation to confirm eligibility. This includes a whole-body PET-CT scan performed within 42 days prior to the first dose of chemoradiotherapy.

Eligibility requires a diagnosis of locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) and no disease progression after at least two cycles of platinum-based chemoradiotherapy.

2 treatment assignment

Participants are assigned to treatment groups based on specific biomarkers. Those with ALK fusion positivity are placed in Cohort A1, while those with ROS1 fusion positivity are placed in Cohort A2.

The treatment involves either alectinib or entrectinib for Cohort A2, and durvalumab for comparison.

3 medication administration

For those receiving alectinib, the medication is administered orally in the form of Alecensa 150 mg hard capsules.

Participants receiving durvalumab will have it administered through intravenous infusion, using IMFINZI 50 mg/mL concentrate for solution for infusion.

4 monitoring and assessments

Regular monitoring is conducted to assess progression-free survival (PFS) and other health indicators. This includes imaging studies and clinical evaluations.

Secondary assessments include time to central nervous system progression, distant metastasis-free survival, and overall survival, among others.

5 patient-reported outcomes

Participants will report on physical functioning, role functioning, and symptoms such as cough, chest pain, and shortness of breath at specified intervals.

Quality of life is measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months.

6 adverse events monitoring

The incidence, type, and severity of any adverse events are recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0.

Changes in vital signs, physical findings, and laboratory results are monitored throughout the study.

Who Can Join the Study?

  • The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC).
  • A special scan called a PET-CT must be done on the whole body before and within 42 days of starting a specific cancer treatment.
  • The lung cancer must be at a stage called locally advanced, unresectable Stage III, which means it has spread locally and cannot be removed by surgery. This must be confirmed by examining tissue samples.
  • The patient must not have had any worsening of the disease during or after receiving at least two cycles of a specific type of cancer treatment called platinum-based chemoradiotherapy.
  • The patient must have a specific genetic change called ALK fusion positivity for one group of the study.
  • The patient must have a specific genetic change called ROS1 fusion positivity for another group of the study.
  • The patient must be able to swallow a medication called entrectinib whole, without chewing, crushing, or opening the capsules, for the group with ROS1 fusion positivity.
  • Both male and female patients can participate in the study.
  • The study includes patients who are considered part of a vulnerable population.

Who Cannot Join the Study?

  • Patients who have had a recent heart attack or severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients who have another type of cancer that is not under control.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study drugs.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
  • Patients who have received another investigational drug within the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Grand Hopital De Charleroi Charleroi Belgium
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital Universitario Ramon Y Cajal Madrid Spain
Hospital Universitario Central De Asturias Oviedo Spain
Hospital General Universitario De Alicante Alicante Spain
HIA Sainte Anne Toulon France
Hospital Clinico Universitario De Valencia Valencia Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Karolinska University Hospital Solna Sweden
Klinikum Chemnitz gGmbH Chemnitz Germany
Hopital Ambroise Pare Boulogne-Billancourt France
Ludwig Maximilian University Of Munich Munich Germany
Instytut Genetyki I Immunologii Genim Sp. z o.o. Lublin Poland
Unite De Recherche Clinique HIA Begin Saint-Mande France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre Francois Baclesse Caen France
Cgvbdh Lnkg Bbqahi Lyon France
Iprebjsh Cdzxzp Dneoxthaeaejbesrv L'hospitalet De Llobregat Spain
Cmdorb Hbdqcydmuac Rrhhccmu Djzgikxxfzfjdv Angers France
Dcagwdlnqtsj Cniitxc Ojlrqfmqr Pzqribgfwnom I Hrvznqvpuxs Wroclaw Poland
Hlbmmwcp Uwgqutwnsifvm Rbyesdvm De Mjlwov Malaga Spain
Ppcv Txmtq Hsrdzdcm Uqhcqguusknb Sabadell Spain
Iqnpldyv Rjzwulykh Psp Lh Swufzn Dao Tfozel Ddyc Aopmhhh Irrk Sptqdz Meldola Italy
Aohuajdrlb Pblztwat Hfzonrmg Da Mvciakiox Marseille France
Uxqcubrketsheitowljbi Wnykjpgdt Amz Wuerzburg Germany
Gfotur Hxadtqupbrt Ugbkseeijaxav Pyoyl Pmpflsoqvlm Ew Ntpjotrewzmy Paris France
Fpdlygvex Pcfq Ld Itmaernymgxhx Bpbugokcd Dlk Hpgfuudw Uvtmypwdcnumx Lf Pki Madrid Spain
Hfwgunfq Vuyr dtqzcuqp Barcelona Spain
Hihavnvq Ukxtszskvpgei ds A Cezjxi A Coruna Galicia Spain
Htxkrfaf Uoaspqdafkxczi Simpypfkni &iqzzma Hwgodop dd Haamfinjurs STRASBOURG, Alsace 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
18.01.2024
France France
Not recruiting
18.01.2024
Germany Germany
Not recruiting
18.01.2024
Italy Italy
Not recruiting
18.01.2024
Norway Norway
Not recruiting
18.01.2024
Poland Poland
Not recruiting
18.01.2024
Spain Spain
Not recruiting
18.01.2024
Sweden Sweden
Not recruiting
18.01.2024
The Netherlands The Netherlands
Not recruiting
18.01.2024

Trial locations

Investigated drugs:

Alectinib is a medication used in this trial to treat patients with a specific type of lung cancer. It works by targeting and blocking certain proteins that help cancer cells grow. This medication is being tested to see how well it works in patients whose cancer has not progressed after receiving other treatments like chemotherapy and radiation.

Entrectinib is another medication being studied in this trial. It is designed to target and inhibit certain proteins that are involved in the growth and spread of cancer cells. The trial aims to determine its effectiveness in patients with lung cancer who have specific biomarkers and have already undergone treatments such as chemotherapy and radiation.

Durvalumab is an immunotherapy drug included in this trial. It helps the immune system recognize and attack cancer cells. The study is evaluating how well durvalumab works in comparison to other treatments for patients with advanced lung cancer who have not shown disease progression after previous therapies.

Investigated diseases:

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 the most common type of lung cancer, accounting for about 85% of all cases. The disease typically starts in the cells lining the lungs and can grow and spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The progression of the disease can vary, with some cases remaining localized while others spread to distant organs. The rate of progression and the specific symptoms can differ based on the subtype and stage of the cancer.

Trial ID:
2023-503920-14-00
Protocol code:
BO42777
Trial Phase:
Therapeutic confirmatory (Phase III)

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