Study Comparing Entrectinib and Crizotinib for Patients with Advanced Non-Small Cell Lung Cancer with ROS1 Gene Changes, With or Without Brain Metastases

1 1 1 1

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) that has a specific genetic change called the ROS1 gene rearrangement. This study is comparing two treatments: Entrectinib (also known by its code name RO 710-2122) and Crizotinib. Both medications are taken orally in the form of hard capsules. The purpose of the study is to evaluate how effective and safe these treatments are for patients with advanced or metastatic NSCLC, which means the cancer has spread to other parts of the body, including the brain.

Participants in the study will be randomly assigned to receive either Entrectinib or Crizotinib. The study will monitor the participants over a period of time to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long the participants live without the cancer getting worse and how the treatments affect their quality of life. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

The study aims to provide valuable information on which treatment might be more beneficial for patients with this specific type of lung cancer. It will also help understand the impact of these treatments on the brain, as some patients may have cancer that has spread to the central nervous system. The results of this study could lead to better treatment options for people with ROS1-positive NSCLC in the future.

1 joining the study

Upon joining the study, a diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with a specific gene rearrangement is confirmed.

Eligibility is determined based on criteria such as no prior treatment with certain inhibitors or chemotherapy, and a life expectancy of at least 12 weeks.

2 randomization

Participants are randomly assigned to receive either entrectinib or crizotinib.

This process ensures that each participant has an equal chance of receiving either medication.

3 medication administration

Participants take the assigned medication orally in the form of hard capsules.

The specific dosage and frequency are determined by the study protocol and are monitored by the study team.

4 monitoring and assessments

Regular assessments are conducted to monitor the progression of the disease and the participant’s response to the medication.

These assessments include imaging tests and evaluations of overall health and quality of life.

5 evaluation of outcomes

The primary outcome measured is progression-free survival, which is the time until the disease progresses or the participant passes away.

Secondary outcomes include overall response rate, duration of response, and overall survival, among others.

6 completion of the study

The study is estimated to end in December 2027.

Upon completion, the data collected will be analyzed to determine the efficacy and safety of the medications.

Who Can Join the Study?

  • Must have a confirmed diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with a specific change in the ROS1 gene.
  • Must not have received any previous treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy, or other treatments for advanced or recurrent NSCLC.
  • Previous radiotherapy is allowed if it was completed more than 14 days before joining the study.
  • Must have a measurable disease according to specific guidelines called RECIST v1.1, which are used to assess the size of tumors.
  • Can have measurable or non-measurable lesions in the central nervous system (CNS), including a condition called leptomeningeal carcinomatosis, which is cancer spread to the membranes surrounding the brain and spinal cord.
  • Must have a life expectancy of at least 12 weeks.
  • Both males and females are eligible to participate.
  • Participants from vulnerable populations are allowed to join the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
KBC Zagreb Zagreb Croatia
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
Hospital Del Mar Barcelona Spain
San Camillo Forlanini Hospital Rome Italy
University Hospital Bratislava Bratislava Slovakia
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Radiotherapy Center Cluj S.R.L. Floresti Romania
Vychodoslovensky Onkologicky Ustav a.s. Kosice Slovakia
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Spitalul Municipal Ploiesti Ploiesti Romania
Hospital Universitario Ramon Y Cajal Madrid Spain
General University Hospital Of Larissa Larissa Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Institutul Regional De Oncologie Iasi Iasi Romania
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Karolinska University Hospital Solna Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Oncomed S.R.L. Timisoara Romania
Justus-Liebig-Universitaet Giessen Giessen Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Hopitaux Prives De Metz Vantoux France
Centre Hospitalier Universitaire De Rennes Rennes France
Netherlands Cancer Institute Amsterdam The Netherlands
Metropolitan Hospital Athens Greece
Cqjylj Lkxd Bobgvw Lyon France
Uffbgzsefo Mkyeyed Cvhefz Hotfnvetepjziexeb Hamburg Germany
Izvlsl Iyesjwev Fichmzpbpwstz Odalanigjsu Rome Italy
Ivuzvisw Ccbqsm Ddvlfhymdxnxvqvws L'hospitalet De Llobregat Spain
Hxievpon Ujnhskgwmumbw Rerqyujv Da Mlrwki Malaga Spain
Lxrmo Glvlnjm Herfohit Of Adhgpv Athens Greece
Idflixic Bszxlrcz Bordeaux France
Aplxyvracb Ppwflpgq Hrhvzsxm Dc Mfiitmvcg Marseille France
Siqqfllzs Rnoogyn Uygeewxcgl Mmgzljm Centxo Nijmegen The Netherlands
Evwbgnk Usyecrxnrkol Msgdisl Cwiejhm Rttyznmkn (tfjzznr Mmn Rotterdam The Netherlands
Hebhygfp Uggiircrlvlct de A Cvdcsi 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
Croatia Croatia
Not recruiting
15.12.2021
France France
Not recruiting
15.12.2021
Germany Germany
Not recruiting
15.12.2021
Greece Greece
Not recruiting
15.12.2021
Italy Italy
Not recruiting
15.12.2021
Romania Romania
Not recruiting
15.12.2021
Slovakia Slovakia
Not recruiting
15.12.2021
Spain Spain
Not recruiting
15.12.2021
Sweden Sweden
Not recruiting
15.12.2021
The Netherlands The Netherlands
Not recruiting
15.12.2021

Trial locations

Investigated drugs:

Entrectinib is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has a genetic change called ROS1 rearrangement. This medication is being tested to see how well it works in patients whose cancer has spread to the brain.

Crizotinib is another medication used in this study. It is already used to treat certain types of lung cancer, including those with ROS1 rearrangements. In this trial, it is being compared to entrectinib to see which one is more effective for patients with this type of lung cancer, especially when the cancer has also spread to the brain.

Investigated diseases:

Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements – This type of lung cancer is characterized by changes in the ROS1 gene, which can lead to abnormal cell growth. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The disease often begins in the cells lining the lungs and can spread to other parts of the body. Patients with this condition may experience symptoms such as coughing, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing a slow progression while others may have a more rapid course. The presence of ROS1 gene rearrangements can influence the behavior of the cancer and its response to certain treatments.

Trial ID:
2023-507494-18-00
Protocol code:
MO41552
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    1 1 1
    Investigated diseases:
    France Germany Spain
  • 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