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Study on Brigatinib and Durvalumab for Patients with Unresectable Stage III Non-Small Cell Lung Cancer with ALK Gene Change After Chemotherapy and Radiation Therapy

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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), specifically in patients who have a change in the ALK-gene. The study is testing the effects of a medication called brigatinib, also known by its code name AP26113, after patients have completed standard chemotherapy and radiation therapy. Another medication involved in the study is durvalumab, which is given as a solution for infusion. The purpose of the study is to evaluate how well brigatinib works in preventing the cancer from getting worse compared to just observation or treatment with durvalumab.

Participants in the study will be randomly assigned to one of the treatment groups. Some will receive brigatinib, which is taken orally as a film-coated tablet, while others may receive durvalumab or be under observation. The study will monitor the participants over a period to see how the cancer responds to these treatments. The main focus is on how long the cancer stays under control without progressing, which is known as progression-free survival. Other aspects like overall survival, which is the length of time patients live after starting the study, and the safety of the treatments will also be observed.

This trial is designed for patients with unresectable stage III NSCLC, meaning the cancer cannot be removed by surgery. It is important for participants to have completed their initial chemo-radiotherapy without the disease progressing. The study aims to provide valuable information on the effectiveness of brigatinib as a consolidation therapy, which is a treatment given after the initial therapy to strengthen its effect, in comparison to other options like durvalumab or observation.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer (NSCLC) with a change in the ALK-gene.

The patient must have completed chemotherapy and radiation therapy without disease progression.

2 randomization

Randomization occurs within 8 weeks after the last radiation therapy session.

The patient is assigned to one of the study groups: observation, brigatinib treatment, or durvalumab treatment.

3 brigatinib treatment

If assigned to the brigatinib group, the patient receives brigatinib in the form of film-coated tablets.

The medication is taken orally, with the dosage and frequency determined by the study protocol.

4 durvalumab treatment

If assigned to the durvalumab group, the patient receives durvalumab as a concentrate for solution for infusion.

The infusion is administered at intervals specified by the study protocol.

5 observation

If assigned to the observation group, the patient does not receive additional medication but is monitored regularly for disease progression.

6 follow-up and monitoring

Throughout the study, the patient’s health is monitored to assess progression-free survival and other outcomes.

Regular check-ups and tests are conducted to evaluate overall survival, CNS-relapse-free survival, and patterns of disease progression.

7 completion of the study

The study is estimated to end by April 2029.

Upon completion, the patient’s participation in the study concludes, and final assessments are conducted.

Who Can Join the Study?

  • The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that cannot be removed by surgery and is at stage III.
  • The cancer must have a specific change called ALK-fusion, which is confirmed by tests on the tumor.
  • The patient should not have received any treatment for this cancer before.
  • The patient must be able to perform daily activities with little or no help, as measured by a scale called ECOG Performance Status of 0 or 1.
  • The patient must be 18 years old or older.
  • The patient should be suitable for receiving a combination of chemotherapy and radiotherapy, as determined by the doctor.
  • Women who can have children must have a negative pregnancy test.
  • The patient must be able to follow the study rules, according to the doctor’s judgment.
  • The patient must sign a document agreeing to participate in the study.
  • After completing radiotherapy, the patient must be ready for the next step of the study within 8 weeks.
  • The patient must have completed radiotherapy to the chest area.
  • The cancer should not have worsened after the initial treatment.
  • The patient must have normal blood, kidney, and liver function.
  • The patient should not have a lung condition called radiation pneumonitis that is severe.
  • Any side effects from previous treatment should be mild, except for hair loss.
  • The patient should be able to perform daily activities with little or no help, as measured by a scale called ECOG Performance Status of 0 to 2.
  • The patient should not have had major surgery within 4 weeks before starting the study treatment. Minor procedures are allowed.
  • The patient should not be taking certain strong medications that affect the liver within 14 days before starting the study treatment.

Who Cannot Join the Study?

  • Patients who have not completed their chemo-radiotherapy treatment.
  • Patients whose cancer has progressed after completing chemo-radiotherapy.
  • Patients who do not have a specific type of lung cancer called ALK-rearranged non-small cell lung cancer (NSCLC). This means their cancer cells have a change in a gene called ALK.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Universitario Lucus Augusti Lugo Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Universita’ Degli Studi Di Verona Verona Italy
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Hospital Universitario Basurto Bilbao Spain
Centre Hospitalier Universitaire De Caen Normandie Caen France
Ivxtwdir Rsjgsjlnh Pkg Ly Senpbw Dtt Toanyp Dntc Agovold Iwwf Siwutc Meldola Italy
Hulbzwkd Gcmmrab Uxnehacsxcuto Dxz Bcfsmt Alicante Spain
Auhlxstkhd Pwmtzhzf Hwuninox Df Mpeiificn Marseille France
Uxwlqkdvcpmjgz Cnzyvqt Kdozkwobl Gdansk Poland
Hmdjolla De Lr Snbha Ckqk I Soix Ppo Barcelona Spain
Cebcwx Hvzblkflrtk Rxmipvyn Dgdzuxcvmxumxn Angers France
Hzuzfhrp Vntt dreeyfij Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.10.2023
Italy Italy
Not recruiting
01.10.2023
Poland Poland
Not recruiting
01.10.2023
Spain Spain
Not recruiting
01.10.2023

Trial locations

Investigated drugs:

Brigatinib is a medication used in this trial as a consolidation therapy. It is being tested to see if it can help prevent the progression of non-small cell lung cancer (NSCLC) in patients who have a specific genetic change known as ALK-rearrangement. This medication is given to patients who have already completed chemotherapy and radiation therapy to see if it can help keep the cancer from coming back or spreading.

Durvalumab is another medication being studied in this trial. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this trial, it is being compared to observation to see if it can improve outcomes for patients with unresectable stage III NSCLC who have completed chemo-radiotherapy.

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 begins in the tissues of the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. 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:
2022-502467-38-00
Protocol code:
ETOP 21-21 BOUNCE
NCT ID:
NCT05718297
Trial Phase:
Therapeutic exploratory (Phase II)

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