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Study Comparing Pralsetinib and Standard Drug Combination for Patients with Advanced RET Fusion-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) that has a specific genetic change called RET fusion. The study is comparing a new treatment called Pralsetinib with standard treatments that include various chemotherapy drugs. These standard treatments may involve medications such as Pemetrexed, Carboplatin, Cisplatin, Gemcitabine, Paclitaxel, and Pembrolizumab. The purpose of the study is to see if Pralsetinib can help patients live longer without their cancer getting worse compared to the usual treatments.

Participants in the study will be randomly assigned to receive either Pralsetinib or one of the standard chemotherapy treatments. The study will monitor the participants over time to see how their cancer responds to the treatment. This includes checking if the cancer shrinks, stays the same, or grows. The study will also look at how long participants live and any side effects they experience. The treatment period can vary, with some treatments lasting up to 104 weeks.

The study is open-label, meaning both the participants and the researchers know which treatment is being given. Participants will receive their treatment through different methods, such as IV infusion or taking capsules orally, depending on the medication. The study aims to provide valuable information on the effectiveness and safety of Pralsetinib compared to the standard care options for patients with this specific type of lung cancer.

1 joining the study

Upon joining the study, the participant is confirmed to have advanced non-small cell lung cancer (NSCLC) that is either stage IIIB or stage IV and has not been treated with systemic anticancer therapy for metastatic disease.

The participant must have a documented RET fusion, which is a specific genetic alteration, confirmed by a certified laboratory.

2 randomization

The participant is randomly assigned to one of two groups: one receiving the investigational drug pralsetinib or the other receiving a standard treatment regimen containing platinum-based drugs.

3 treatment administration

Participants in the pralsetinib group take the medication orally. The dosage and frequency are determined by the study protocol.

Participants in the standard treatment group receive medications such as pemetrexed, carboplatin, cisplatin, paclitaxel, paclitaxel albumin-bound, pembrolizumab, or gemcitabine through intravenous infusion or injection, depending on the specific drug.

4 monitoring and assessments

Participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects. This includes imaging tests to evaluate tumor response and regular health check-ups.

The primary goal is to measure progression-free survival, which is the time during and after treatment that the participant lives with the disease without it getting worse.

5 completion of treatment

The treatment continues until the disease progresses, unacceptable side effects occur, or the participant decides to withdraw from the study.

The study is estimated to conclude by May 31, 2025.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body. This includes both squamous and non-squamous types of NSCLC.
  • The patient must have a RET fusion, which is a specific genetic change in the cancer. This must be confirmed by a certified laboratory using tissue or blood samples.
  • The patient must have cancer that can be measured by doctors using a standard method called RECIST 1.1. If the cancer was treated with radiation before, it must have grown again to be considered measurable.
  • The patient must have an ECOG Performance Status of 0-1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must test negative for HIV at the start of the study. If they are HIV positive, they must be stable on treatment, have a certain level of immune cells (CD4 count ≥ 200/µL), and have no detectable virus in their blood.
  • The patient must not have received any previous treatment for cancer that has spread. They can have had treatment before if it was not for the spread of cancer and if it was completed at least 6 months before the cancer came back.
  • Both male and female patients can participate in the study.

Who Cannot Join the Study?

  • Patients who do not have RET fusion-positive cancer. This means the cancer cells have a specific change in their genes.
  • Patients whose cancer is not metastatic. This means the cancer has not spread to other parts of the body.
  • Patients who do not have Non-Small Cell Lung Cancer. This is a type of lung cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication or similar drugs.
  • Patients who are not willing or able to provide informed consent, which means agreeing to participate after understanding the study details.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Hopital Tenon Paris France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Asklepios Klinik Gauting GmbH Gauting Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH Schweinfurt Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Hospital Clinic De Barcelona Barcelona Spain
Hopital Ambroise Pare Boulogne-Billancourt France
Consorcio Hospital General Universitario De Valencia Castello De La Plana Spain
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Ipsyyv Isgskzqy Fnmndsxukehrc Obnjruynlxf Rome Italy
Uaeibkcxymuv Mdhafks Cwrdnhp Gviipuznv Groningen The Netherlands
Apqwvuj Olmfyklrrnv S Ghdldqsh Aqhmqrmvav Rome Italy
Ntxfuehq Iijfzmwy Ouccojedv Ifs Mfmjq Sqzawjljfqgniwdkaqptiitodmlz Ixbgcsmk Bvgaqxxy Cracow Poland
Ungknxsoiw Ow Atoxkui Edegem Belgium
Ivxixjxv Cvqgkn Deqirdhqzyhuzwekn L'hospitalet De Llobregat Spain
Hhmfgljc Umuvwghxclfao Hlclcfai Tyeln y Pfpguw Iatlckig Crzomb dimmhjdgqoviddmxv (mgcg Badalona Spain
Iwtdcuvg Pliaqsrunkyqxph Cuotma Ckmkmz Marseille France
Hiboabff Uzpfducecyneoh Snmqslnbff &ahuspk Hxnsesj dw Hlenaxzlnsh STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
22.10.2020
France France
Not recruiting
22.10.2020
Germany Germany
Not recruiting
22.10.2020
Ireland Ireland
Not recruiting
22.10.2020
Italy Italy
Not recruiting
22.10.2020
Norway Norway
Not recruiting
22.10.2020
Poland Poland
Not recruiting
22.10.2020
Portugal Portugal
Not recruiting
22.10.2020
Spain Spain
Not recruiting
22.10.2020
The Netherlands The Netherlands
Not recruiting
22.10.2020

Trial locations

Investigated drugs:

Pralsetinib is a medication being studied for its effectiveness in treating a specific type of lung cancer known as RET fusion-positive metastatic non-small cell lung cancer (NSCLC). This medication is being compared to standard treatments to see if it can help patients live longer without their cancer getting worse.

Standard of Care refers to the usual treatment options that doctors typically use for this type of lung cancer. In this study, it includes various anticancer treatments that contain platinum, which is a common component in chemotherapy regimens. The goal is to determine if pralsetinib offers any advantages over these standard treatments.

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 characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. The disease often progresses slowly compared to small cell lung cancer, and symptoms may include persistent cough, chest pain, and shortness of breath. In some cases, the cancer can spread to other parts of the body, a process known as metastasis. RET fusion-positive refers to a specific genetic alteration found in some cases of this cancer, which can influence the behavior and treatment response of the disease.

Trial ID:
2023-505035-12-00
Protocol code:
BO42864
Trial Phase:
Therapeutic confirmatory (Phase III)

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