Study on the Effectiveness and Safety of Alectinib, Entrectinib, and a Drug Combination for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

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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 (NSCLC), a type of lung cancer that has spread beyond the lungs. The study aims to evaluate the effectiveness and safety of several targeted therapies. These therapies include alectinib for patients with specific genetic changes known as ALK+ or RET+, entrectinib for those with ROS1+ mutations, and a combination of atezolizumab, cobimetinib, and vemurafenib for patients with BRAF V600+ mutations. Additionally, the study will assess the combination of atezolizumab, bevacizumab, carboplatin, and pemetrexed for patients with EGFR exon 20+ mutations.

The purpose of the study is to determine how well these treatments work in patients whose cancer has specific genetic mutations detected through a blood test. Participants will receive one of the targeted therapies or a combination of therapies, depending on their specific genetic profile. Some patients may receive a placebo as part of the study. The treatments will be administered either orally or through intravenous infusion, depending on the medication. The study will monitor the participants’ response to the treatment, including any side effects they may experience.

Throughout the study, participants will undergo regular check-ups and tests to track their progress and ensure their safety. The study will last for a period of time, during which the effectiveness of the treatments will be evaluated. The goal is to find the most effective treatment options for patients with advanced or metastatic NSCLC, based on their unique genetic makeup.

1 joining the study

Upon joining the study, a diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) is confirmed.

Eligibility is determined based on specific criteria, including measurable disease and adequate organ function.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and establish a baseline for the study.

This includes various tests and measurements to ensure readiness for the trial.

3 treatment assignment

Based on specific genetic markers, a treatment plan is assigned.

Possible treatments include alectinib, entrectinib, atezolizumab combined with other medications, or vemurafenib.

4 treatment administration

Medications are administered according to the assigned treatment plan.

Oral medications such as alectinib and entrectinib are taken as film-coated tablets or capsules.

Intravenous medications like atezolizumab are given through infusions.

5 ongoing monitoring

Regular monitoring is conducted to assess the effectiveness and safety of the treatment.

This includes tracking any side effects and adjusting the treatment as necessary.

6 follow-up assessments

Periodic assessments are performed to evaluate the response to treatment.

These assessments help determine the overall progress and any necessary changes to the treatment plan.

7 completion of the study

Upon completion of the study, a final assessment is conducted to evaluate the outcomes.

The results contribute to understanding the efficacy and safety of the treatments for NSCLC.

Who Can Join the Study?

Must have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC). This means the cancer is in a late stage and has spread to other parts of the body.
The cancer must be unresectable, meaning it cannot be removed with surgery, and classified as Stage IIIb or Stage IV.
Must have measurable disease. This means the cancer can be measured in size using specific criteria called RECIST, version 1.1.
Must have adequate recovery from the most recent cancer treatment, whether it was a drug treatment or a local treatment like radiation.
Must have adequate organ function, meaning the organs are working well enough to handle the treatment.
Must have a life expectancy of at least 12 weeks, meaning the doctors expect the patient to live for at least 3 more months.
Female patients who can have children and male patients must be willing to use acceptable methods of contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Non-small cell lung cancer (NSCLC).
Patients who are not in the advanced or metastatic stage of NSCLC. This means the cancer has not spread to other parts of the body.
Patients who are not selected based on specific test results from the FoundationOne Liquid Companion Diagnostic (F1LCDx).
Patients who are not within the specified age range for the study.
Patients who are not eligible based on gender, as the study includes both male and female participants.
Patients who belong to a vulnerable population that is not selected for this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Asklepios Klinik Gauting GmbH	Gauting	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
San Camillo Forlanini Hospital	Rome	Italy
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Hopital Beaujon	Clichy	France
Vrije Universiteit Brussel	Jette	Belgium
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy	Otwock	Poland
Ccbhlggzu Uaaipdkykvmssb Swozxhvdc	Woluwe-Saint-Lambert	Belgium
Hadalp Dwm Htube Sailrap Kiktnsix Wrgnetwzy Gcoe	Wiesbaden	Germany
Ioufomqe Cqibhu Doyxmnfmrqmggfcce	L'hospitalet De Llobregat	Spain
Idkbokaw Rqambiezf Pmw Lt Sgumys Deo Tinfpg Djwe Ahoecjr Itbz Swssjc	Meldola	Italy
Noagjvgi Ikevrgvl Olqbcidlz Isi Mkcmg Stuagwritkqnybmgmzffrvjfqbbr Isqmglya Badwiige	Cracow	Poland
Uegowkghijbvmo Cjwauuk Kkrbzsmpm	Gdansk	Poland
Alovvde Oiieoeoafqx Podv Gbqyypfm Xeqsd	Bergamo	Italy
Hfqjoume Uqrlkkfzrfshk Hcrjhmwe Tdhlt y Pespng Iomqpzlr Ctucnh dsmejxojhjqhnroao (aclj	Badalona	Spain
Hxusrcbx Vzlk dvomawbz	Barcelona	Spain
Kckvwjvjx Scagxcf Sqqpjtneurllney iw Jcej Pscti Ij	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.10.2017
France	Not recruiting	30.10.2017
Germany	Not recruiting	30.10.2017
Italy	Not recruiting	30.10.2017
Poland	Not recruiting	30.10.2017
Spain	Not recruiting	30.10.2017

Trial locations

Alectinib is a medication used in this trial for patients with non-small cell lung cancer (NSCLC) who have specific genetic changes known as ALK or RET mutations. It works by targeting and blocking the proteins produced by these mutations, which can help slow down or stop the growth of cancer cells.

Entrectinib is another targeted therapy in the trial, used for patients with NSCLC who have ROS1 mutations. This medication helps to inhibit the activity of the ROS1 protein, which can contribute to the growth and spread of cancer cells.

Atezolizumab is an immunotherapy drug included in the trial. It is used in combination with other medications to help the immune system recognize and attack cancer cells more effectively. In this study, it is combined with other drugs for patients with specific genetic mutations in their cancer.

Cobimetinib is used alongside atezolizumab and vemurafenib for patients with BRAF V600 mutations. It works by blocking certain proteins that promote cancer cell growth, enhancing the effects of the other medications in the combination.

Vemurafenib is part of the combination therapy with atezolizumab and cobimetinib for patients with BRAF V600 mutations. It specifically targets and inhibits the activity of the BRAF protein, which is involved in cell growth and division.

Bevacizumab is used in combination with atezolizumab, carboplatin, and pemetrexed for patients with EGFR exon 20 mutations. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, helping to slow down tumor growth.

Carboplatin is a chemotherapy drug used in the trial as part of a combination therapy. It works by damaging the DNA of cancer cells, which can prevent them from dividing and growing.

Pemetrexed is another chemotherapy medication included in the combination therapy. It interferes with the growth of cancer cells by blocking the formation of DNA and RNA, which are essential for cell division and growth.

Investigated diseases:

Non-small cell lung cancer

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 progress to invade nearby tissues and organs. As it advances, it may spread to lymph nodes and other parts of the body. Symptoms can include a persistent cough, chest pain, and difficulty breathing.

Trial ID:

2023-507500-31-00

Protocol code:

BO29554

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effectiveness and Safety of Alectinib, Entrectinib, and a Drug Combination for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?