Study Comparing Selpercatinib with a 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 Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. The study aims to compare the effectiveness of a new treatment called Selpercatinib with a combination of existing treatments. These existing treatments include Platinum-Based therapies such as Carboplatin or Cisplatin, Pemetrexed, and Pembrolizumab. The purpose of the study is to see how well Selpercatinib works compared to these other treatments in patients with this specific type of lung cancer.

Participants in the study will receive either Selpercatinib or a combination of the other treatments. The study will monitor the progress of the disease and how the treatments affect it. The treatments will be given through different methods, such as infusion, which is a way of delivering medicine directly into the bloodstream, or oral use, which involves taking medicine by mouth. The study will take place over a period of time, and participants will be closely observed to understand the effects of the treatments.

The study is designed to provide valuable information about the potential benefits of Selpercatinib for patients with RET Fusion-Positive Non-Small Cell Lung Cancer. By comparing it with existing treatments, researchers hope to find the most effective way to manage this type of cancer. The results of this study could lead to improved treatment options for patients in the future.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes verifying the presence of advanced or metastatic non-small cell lung cancer (NSCLC) with a specific genetic feature called RET fusion.

Participants must have sufficient tumor tissue available for confirmatory testing and be in fair to good health without other serious medical conditions.

2 treatment group assignment

Participants are randomly assigned to one of two treatment groups. One group receives selpercatinib, and the other group receives a combination of platinum-based therapy (either carboplatin or cisplatin), pemetrexed, and possibly pembrolizumab.

3 selpercatinib administration

For those in the selpercatinib group, the medication is taken orally. The specific dosage and frequency are determined by the study protocol and the participant’s health status.

4 platinum-based therapy administration

Participants in the platinum-based therapy group receive carboplatin or cisplatin through infusion. The dosage and frequency are based on the study protocol.

5 pemetrexed administration

Pemetrexed is administered via infusion to participants in the platinum-based therapy group. The schedule is determined by the study protocol.

6 pembrolizumab administration

If assigned, pembrolizumab is given through infusion. The decision to include pembrolizumab is based on the study protocol.

7 monitoring and follow-up

Throughout the trial, participants undergo regular monitoring to assess the effectiveness of the treatment and any side effects. This includes medical examinations and imaging tests.

The trial aims to compare the progression-free survival (PFS) of participants receiving selpercatinib with those receiving the combination therapy.

8 trial completion

The trial is expected to conclude by June 18, 2026. Participants will be informed of the results and any further steps after the trial ends.

Who Can Join the Study?

  • Participants must have advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation therapy. Advanced or metastatic means the cancer has spread to other parts of the body.
  • Participants must have a RET gene fusion and enough tumor tissue available for confirmatory testing. A RET gene fusion is a specific change in the cancer cells that can be tested.
  • Participants must be in fair to good health and not have another serious medical condition.
  • Participants must not have had prior chemotherapy for metastatic lung cancer. Chemotherapy given after surgery (adjuvant) or before surgery (neoadjuvant) is allowed.
  • Participants must not have disease that has spread to the brain and is causing symptoms.
  • Participants must be able to swallow capsules.
  • Participants must be willing to use highly effective contraception during the study.

Who Cannot Join the Study?

  • Patients who do not have advanced or metastatic RET fusion-positive non-small cell lung cancer. This means the cancer must have spread to other parts of the body and have a specific genetic change called RET fusion.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hospital Son Llatzer Palma Spain
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Jeroen Bosch Ziekenhuis Stichting S-Hertogenbosch The Netherlands
Vrije Universiteit Brussel Jette Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Servei De Salut De Les Illes Balears Palma Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Vitaz Sint-Niklaas Belgium
Hospital Universitario De Jaen Jaen Spain
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Ihqzozll Rfjbjfeq Dl Cytiep Do Mmpelxazxrh Montpellier France
Asqljuwlp Upd Amsterdam The Netherlands
Ewkuawb Uuememlbmqpt Mktqvks Clobyws Rdswgdcvm (aclvlge Mnf Rotterdam The Netherlands
Aukuyc Mxybbfp Cbiwhi Sghk Thessaloniki Greece
Aumzrbh Uywie Stouecgdz Leyzfp Dv Bwnooue Bologna Italy
Hgctmrqg Dc Ld Szbjo Clsz I Sggb Pbw Barcelona Spain
Cfmokx Lspl Bnwoqg Lyon France
Iiudes Iidilemp Fkagbyopqavzi Opzrnhuptiw Rome Italy
Ieuvqtmu Cuedjr Dktyhibxhqjkpafce L'hospitalet De Llobregat Spain
Exyscat Mechelen Belgium

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
17.02.2020
France France
Not recruiting
17.02.2020
Germany Germany
Not recruiting
17.02.2020
Greece Greece
Not recruiting
17.02.2020
Italy Italy
Not recruiting
17.02.2020
Spain Spain
Not recruiting
17.02.2020
The Netherlands The Netherlands
Not recruiting
17.02.2020

Trial locations

Selpercatinib is a medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change known as RET fusion. It works by targeting and blocking the activity of proteins that help cancer cells grow.

Carboplatin is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.

Cisplatin is another chemotherapy medication similar to carboplatin. It is used to treat different cancers by interfering with the DNA in cancer cells, stopping them from multiplying.

Pemetrexed is a chemotherapy drug that is often used in combination with other medications to treat lung cancer. It works by blocking the cancer cells’ ability to use folate, a vitamin that is necessary for their growth.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used to treat various types of cancer, including lung cancer, by blocking a protein that prevents the immune system from attacking cancer cells.

Investigated Diseases:

Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as RET fusion. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. The disease is considered advanced or metastatic when it has spread beyond the lungs to other parts of the body. RET fusion-positive indicates that the cancer cells have a rearrangement in the RET gene, which can drive cancer growth. This genetic change can make the cancer more aggressive and influence how it progresses. The progression of this disease can vary, but it often involves the growth and spread of cancerous cells to distant organs.

Trial ID:
2023-506783-14-00
Protocol code:
J2G-MC-JZJC
Trial Phase:
Therapeutic confirmatory (Phase III)

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