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Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced soft-tissue sarcomas, which are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. The study aims to explore the use of a method called next generation sequencing (NGS) to analyze the genetic material of these tumors. This method helps in understanding the genetic changes in the cancer cells, which can guide the selection of the most appropriate treatment for each patient. The trial will involve the collection of blood and tumor samples from participants to perform this genetic analysis.

Participants in the study will receive one of several treatments, which may include medications such as Futibatinib, IMFINZI (also known as DURVALUMAB or MEDI4736), Lynparza (containing OLAPARIB), Mekinist (containing TRAMETINIB), IBRANCE (containing PALBOCICLIB), Daurismo (containing GLASDEGIB), Tabrecta (containing CAPMATINIB), Tafinlar (containing DABRAFENIB), Tasigna (containing NILOTINIB), Tyverb (containing LAPATINIB), and Zykadia (containing CERITINIB). Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The purpose of the study is to determine how feasible it is to use NGS to provide a detailed genetic report that can help doctors make informed treatment decisions. The study will monitor participants over a period to see how well they respond to the treatments and to assess their overall survival and progression-free survival, which refers to the time during and after treatment that a patient lives with the disease without it getting worse. The trial will also evaluate the cost-effectiveness of using NGS in treatment planning. Participants will be followed up to see how their tumors respond to the treatments and to gather data on their quality of life during the study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    A written informed consent is required before any study-specific procedures begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information. This includes a review of medical history and a physical examination.

    Blood and tumor samples are collected for molecular analysis.

  3. Step 3

    Molecular profiling

    High throughput molecular analysis, known as next generation sequencing (NGS), is performed on the collected samples.

    The goal is to identify any genetic alterations that may be present in the tumor.

  4. Step 4

    Treatment assignment

    Based on the results of the molecular profiling, a treatment plan is developed.

    Participants may receive one or more of the following medications: Futibatinib, IMFINZI, Lynparza, Mekinist, IBRANCE, Daurismo, Tabrecta, Tafinlar, Tasigna, Tyverb, Zykadia.

  5. Step 5

    Medication administration

    Medications are administered either orally or intravenously, depending on the specific drug.

    Dosages and frequency vary by medication and are determined by the study protocol.

  6. Step 6

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status and response to treatment.

    Progress is assessed using imaging studies and other diagnostic tests as needed.

  7. Step 7

    End of study participation

    Participation in the study concludes at the end of the treatment period or if the participant chooses to withdraw.

    Final assessments are conducted to evaluate overall health and treatment outcomes.

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Eligible for the first round of treatment that affects the whole body.
  • No other cancer diagnosed or treated in the last two years, except for certain types that are not expected to affect the study results.
  • Must have social security as required by French law.
  • Must voluntarily sign a written consent form before any study procedures begin.
  • Must have a type of cancer called soft-tissue sarcoma, confirmed by a specific network in France.
  • The cancer must be unresectable (cannot be removed by surgery) and either locally advanced or has spread to other parts of the body.
  • No previous treatment that affects the whole body for advanced cancer.
  • Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
  • Must have adequate blood and body functions, including hemoglobin levels above 9 g/dL and albumin levels above 30 g/L.
  • Must have a measurable disease according to specific criteria, with at least one tumor that is larger than 10 mm in one dimension.
  • Must have suitable frozen tumor material from a metastatic lesion or advanced disease that has not been treated, or a lesion that can be biopsied for research.
  • Must have an archived block of tumor sample taken at any time during the disease for research purposes.

Who cannot join the trial?

1 criterion

  • Participants with a type of cancer called unresectable locally advanced and/or metastatic soft-tissue sarcoma cannot join the study. This means the cancer has spread and cannot be removed by surgery.
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Investigated drugs

NGS (Next Generation Sequencing): This is a technology used to analyze the genetic material of participants with advanced soft-tissue sarcomas. The goal is to understand the genetic makeup of the tumors better. By doing this, doctors can identify specific genetic changes that might be driving the cancer. This information can help in making more informed decisions about the best treatment options for each patient.

What is already known about the treatment

Trabectedin – Trabectedin is administered intravenously, typically through an infusion into a vein. It is currently used in the treatment of unresectable locally advanced or metastatic soft-tissue sarcoma, as explored in clinical trials like the MULTISARC study. The medication works by binding to the minor groove of DNA, disrupting the cell cycle and leading to cell death, particularly in cancer cells. It is classified as an alkylating agent, which is a type of chemotherapy drug.

Investigated diseases

Unresectable Locally Advanced and/or Metastatic Soft-Tissue Sarcoma – This is a type of cancer that originates in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. It is considered unresectable when it cannot be surgically removed due to its location or size. The disease may be locally advanced, meaning it has spread extensively within the area of origin, or metastatic, indicating it has spread to other parts of the body. Soft-tissue sarcomas can grow and spread at varying rates, depending on the specific type and location. Symptoms often include a noticeable lump or swelling, which may or may not be painful. As the disease progresses, it can affect the function of nearby organs and tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514873-22-00Protocol codeC16-40Estimated enrolment960 patientsSponsorInstitut National De La Sante Et De La Recherche Medicale

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