Study Comparing Repotrectinib and Crizotinib for Patients with Advanced or Metastatic ROS1-positive Non-Small Cell Lung Cancer

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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 specifically looking at cases where the cancer is locally advanced or has spread to other parts of the body, and where patients have a specific genetic feature called ROS1-positive. The trial will compare two treatments: Repotrectinib (TPX-0005) and Crizotinib. Both of these medications are taken orally in the form of hard capsules and are designed to target and inhibit certain proteins that help cancer cells grow.

The purpose of this study is to see how well these treatments work in preventing the cancer from getting worse. Participants in the trial will be randomly assigned to receive either Repotrectinib or Crizotinib. The study will monitor the participants over time to assess the effectiveness of the treatments in controlling the cancer. This will involve regular check-ups and assessments by medical professionals to track the progress of the disease and any side effects from the medications.

Throughout the study, the main focus will be on how long the participants can live without their cancer progressing, which is known as progression-free survival. Other aspects being studied include overall survival, how well the cancer responds to the treatment, and the duration of this response. The trial will also look at the time it takes for the treatment to start working and any potential side effects. The study aims to provide valuable information that could help improve treatment options for people with this type of lung cancer in the future.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either Repotrectinib or Crizotinib. This is to compare the effectiveness of these medications in treating your condition.

2 medication administration

If assigned to Repotrectinib, you will take it orally in the form of hard capsules. The specific dosage and frequency will be provided by the study team.

If assigned to Crizotinib, you will also take it orally in the form of hard capsules. The dosage could be either 250 mg or 200 mg, and the frequency will be specified by the study team.

3 regular check-ups

Throughout the study, regular check-ups will be scheduled to monitor your health and the effectiveness of the treatment. These check-ups will include various tests and assessments as determined by the study protocol.

4 progress evaluation

Your progress will be evaluated based on Progression Free Survival (PFS), which measures the time during and after treatment that you live with the disease without it getting worse.

Other evaluations will include overall survival, response rates, and any side effects experienced during the trial.

5 completion of the study

The study is expected to continue until July 25, 2031. Upon completion, you will have a final assessment to evaluate the overall impact of the treatment.

Who Can Join the Study?

  • The participant must have a confirmed diagnosis of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread beyond the lungs.
  • The participant must have a ROS1 gene rearrangement/fusion. This is a specific change in the genes that can be detected by a test.
  • The participant must have at least one measurable tumor or lesion, which is a growth or area of disease that can be measured by the doctor.
  • The participant must not have been treated before with certain drugs called TKIs that work on ROS1-positive NSCLC.
  • The participant can have had up to one previous treatment for NSCLC.
  • The participant must have an ECOG Performance Status of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities. A lower number means the person is more active.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients who have had another cancer within the last 3 years, except for certain skin cancers or in situ cervical cancer, are excluded.
  • Patients who have received certain treatments for NSCLC, such as chemotherapy or targeted therapy, within a specific time frame before the study starts, are not eligible.
  • Patients with uncontrolled or severe heart conditions, such as heart failure or irregular heartbeats, cannot join the study.
  • Patients with active infections that require treatment with antibiotics or antiviral medications are excluded.
  • Patients with known allergies to the study drugs or similar drugs cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible for the study.
  • Patients who have participated in another clinical trial within a certain period before this study starts are excluded.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Koranyi National Institute For Pulmonology Budapest Hungary
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
General University Hospital Of Patras Patras Greece
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Instytut Genetyki I Immunologii Genim Sp. z o.o. Lublin Poland
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Centre Hospitalier Universitaire Rouen Rouen France
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Virgen del Rocío University Hospital Sevilla Spain
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Marienhaus Klinikum Mainz GmbH Mainz Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Lungenfachklinik Immenhausen Immenhausen Germany
Ueocyxrwenfv Mthzodq Cdiptoe Gcaptlilu Groningen The Netherlands
Tdiejdrsgh Ckcrtx Huxpybzg Thessaloniki Greece
Uixhlrazes Hdrpxmhd Cxwvajz Cologne Germany
Atxyrblwmj Pdmjrfzy Hxkrqsri Du Pcorn Paris France
Alfewdxad Uck Amsterdam The Netherlands
Ifegzb Ilyclqub Fmndhduefmhmw Ohzbogyxfqp Rome Italy
Hsqhcssk Vtos dmknqnre Barcelona Spain
Hyqqyabo Uakgoqtaoxexs dy A Cmhoxa A Coruna Galicia Spain
Uwgiqxmhdf Gtrbsjg Htxzzufu Adjvglg Athens Greece

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
10.11.2023
France France
Not recruiting
10.11.2023
Germany Germany
Not recruiting
10.11.2023
Greece Greece
Not recruiting
10.11.2023
Hungary Hungary
Not recruiting
10.11.2023
Italy Italy
Not recruiting
10.11.2023
Poland Poland
Not recruiting
10.11.2023
Romania Romania
Not recruiting
10.11.2023
Spain Spain
Not recruiting
10.11.2023
The Netherlands The Netherlands
Not recruiting
10.11.2023

Trial locations

Investigated drugs:

Repotrectinib is a medication being studied for its potential to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that is positive for a specific protein called ROS1. This medication works by blocking certain proteins in cancer cells that help them grow and spread. By doing this, repotrectinib may help to slow down or stop the progression of the cancer.

Crizotinib is another medication used in this study, which is already approved for treating certain types of lung cancer. It targets and blocks specific proteins in cancer cells, similar to repotrectinib, to help prevent the cancer from growing and spreading. In this trial, crizotinib is being compared to repotrectinib to see which one is more effective in treating patients with ROS1 positive non-small cell lung cancer.

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. As it advances, it may invade nearby tissues and organs, potentially spreading to lymph nodes and other areas. The progression can lead to symptoms like persistent cough, chest pain, and difficulty breathing. Over time, the disease can affect the overall health and function of the respiratory system.

Trial ID:
2023-505604-32-00
Protocol code:
CA127-1030
Trial Phase:
Therapeutic confirmatory (Phase III)

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