Study of Selpercatinib for Patients with Early-Stage RET Fusion-Positive Non-Small Cell Lung Cancer After Local Treatment

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as RET fusion-positive non-small cell lung cancer (NSCLC). The treatment being tested is a medication called selpercatinib, which is a small molecule kinase inhibitor. This medication is taken orally in the form of a hard capsule. The study also involves a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness of selpercatinib in patients who have early-stage RET fusion-positive NSCLC and have already undergone surgery or radiation treatment. Participants in the study will be randomly assigned to receive either selpercatinib or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will be monitored to assess the progression of their condition and any potential side effects of the treatment. The trial aims to provide valuable information on whether selpercatinib can improve outcomes for patients with this specific type of lung cancer. The study is expected to continue for several years to gather comprehensive data on the treatment’s effectiveness and safety.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must have early-stage non-small cell lung cancer (NSCLC) and have recovered from surgery or radiation. Good health is required, and effective birth control must be used during the study.

2 randomization

Participants are randomly assigned to receive either selpercatinib or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

Selpercatinib is taken orally. The exact dosage and frequency are determined by the study protocol and are administered consistently throughout the trial period.

4 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment. This includes tracking the event-free survival (EFS) of participants, which is assessed by investigators.

5 completion of the study

The study is estimated to conclude by August 14, 2032. Participants will be informed of their treatment group and the overall results of the study at the end of the trial.

Who Can Join the Study?

  • Participants must have early-stage non-small cell lung cancer (NSCLC). This is a type of lung cancer that is in its initial stages.
  • Participants must have already had surgery or radiation and have recovered from it.
  • Participants must be in fair to good health, meaning they should generally feel well and not have serious health issues.
  • Participants must be willing to use highly effective birth control during the study to prevent pregnancy.
  • Both males and females can participate in the study.
  • The study includes people who might be considered vulnerable, meaning they may need extra care or protection.

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
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Centre Hospitalier Universitaire Rouen Rouen France
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Assistance Publique Hopitaux De Marseille Marseille France
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
General University Hospital Of Patras Patras Greece
Athens Medical Center S.A. Thessaloniki Greece
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Centre Leon Berard Lyon France
University Of Antwerp Edegem Belgium
Oslo Universitetssykehus HF Oslo Norway
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University General Hospital Of Heraklion Heraklion Greece
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario De Leon Leon Spain
Hospital Universitario Lucus Augusti Lugo Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Hospital Universitario De Canarias La Laguna Spain
Hospital Alvaro Cunqueiro Vigo Spain
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience Paris France
Isala Klinieken Stichting Zwolle The Netherlands
Hospital Universitario Puerta Del Mar Cadiz Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Henry Dunant Hospital Center Athens Greece
Clinique Saint-Pierre Ottignies (CSPO) Ottignies Belgium

Other Sites

Site Name City Country Status
Hospital Son Llatzer Palma Spain
Consorci Sanitari Del Maresme Mataró Spain
Fakultni Nemocnice Bulovka Prague Czechia
Hospital General Universitario De Albacete Albacete Spain
Sikdq Snlj Jcrn Do Rucb Reus Spain
Cankzu Htiixbqossw Ucijghareqnjq Droski Gfxiqgz Smdvlzmlethwnxhmlxqqpnfxkj Namur Belgium
Ktsjycrsepc Nitg Kwottn Fmeqguygxse Vienna Austria
Vfrrkrkcuexf Ksgyimvxcyzfaqdknrkuylyneobchmzk min Feldkirch Austria
Wdppwfauheere Cnokega Pvurgarmbccg I Tqlafjjwsoujfup Ivu Eaxhxga I Jdvvoay Znhvqdsfu Poznan Poland
Jmgyoz Bpdit Zobqchzzce Sjzycepex S-Hertogenbosch The Netherlands
Sfdml Sumifq Oyqtqnkg Hmlckkbs Athens Greece
Mi Abhartgl Ctyejm Catapo Madrid Spain
Zmxntiwucg Sl Jpakmzj Harderwijk The Netherlands
Kzllmblfl Sxsdgvt Suyhoeskfxxzjjp iz Jmaa Pojhk Iq Cracow Poland
Nawhyans Iafzckph Oyeoczuaa ijjdtkhf Sbpwckzizuqkwfnteyfevmvgkj Noxvaohejz Pvzwn i Kmzwzl Pnyihiqxyx Warsaw Poland

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
31.07.2021
Belgium Belgium
Not recruiting
31.07.2021
Czechia Czechia
Not recruiting
31.07.2021
Denmark Denmark
Not recruiting
31.07.2021
France France
Not recruiting
31.07.2021
Germany Germany
Not recruiting
31.07.2021
Greece Greece
Not recruiting
31.07.2021
Italy Italy
Not recruiting
31.07.2021
Norway Norway
Not recruiting
31.07.2021
Poland Poland
Not recruiting
31.07.2021
Romania Romania
Not recruiting
31.07.2021
Spain Spain
Not recruiting
31.07.2021
Sweden Sweden
Not recruiting
31.07.2021
The Netherlands The Netherlands
Not recruiting
31.07.2021

Trial locations

Investigated Drugs:

Selpercatinib is a medication being studied for its potential to help people with a specific type of lung cancer known as RET fusion-positive non-small cell lung cancer (NSCLC). This medication is being tested to see if it can improve the time patients live without their cancer getting worse after they have received their initial treatment. It is used in this study to see if it can prevent the cancer from returning or spreading.

Investigated Diseases:

RET fusion-positive non-small cell lung cancer (NSCLC) – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as RET fusion. It primarily affects the cells lining the lungs and is a subtype of non-small cell lung cancer, which is the most common form of lung cancer. The disease progresses as the cancerous cells grow and divide uncontrollably, potentially spreading to other parts of the body. Symptoms may include persistent cough, chest pain, and difficulty breathing. The presence of RET fusion can influence the behavior of the cancer and its response to certain treatments. Understanding the genetic makeup of the cancer is crucial for determining the most effective treatment approach.

Trial ID:
2023-506784-33-00
Protocol code:
J2G-MC-JZJX
Trial Phase:
Therapeutic confirmatory (Phase III)

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