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Study of roginolisib, dostarlimab and docetaxel combination for patients with advanced non-small cell lung cancer who did not respond to previous immunotherapy and chemotherapy

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What is this trial about?

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

This study focuses on treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have not responded well to previous treatments. The research evaluates a combination therapy using three medications: roginolisib (also known as IOA-244), dostarlimab (JEMPERLI), and docetaxel. These medications will be tested in different combinations to find the most effective treatment approach for patients whose cancer has continued to progress despite earlier treatments.

The purpose of this research is to determine if these medications can work together safely and effectively to treat advanced lung cancer. Roginolisib is given as a tablet that patients take by mouth, while dostarlimab and docetaxel are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

During the study, participants will receive different combinations of these medications. Some patients will receive roginolisib with dostarlimab, while others will receive all three medications together. The study will monitor how patients respond to the treatment and track any side effects that may occur. Regular medical check-ups and blood tests will be performed to ensure patient safety throughout the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the trial will be confirmed through medical tests and examinations

    You must be at least 18 years old and have confirmed advanced non-squamous non-small cell lung cancer (NSCLC)

    Your physical condition will be evaluated using the ECOG performance scale, which must be 0 or 1

    Pregnancy test will be performed if applicable

  2. Step 2

    Treatment assignment

    You will be assigned to receive a combination of medications:

    Dostarlimab (Jemperli) through intravenous infusion

    Roginolisib (IOA-244) in tablet form taken by mouth

    Some patients may also receive Docetaxel through intravenous infusion

  3. Step 3

    Treatment period

    Your treatment will continue until day 42 for initial assessment

    Regular medical examinations and blood tests will be performed

    Your tumor response will be measured using imaging scans

    Blood samples will be taken to measure medication levels in your body

  4. Step 4

    Safety monitoring

    Any side effects will be monitored and recorded

    Regular laboratory tests will check your blood counts and organ function

    Physical examinations will be performed throughout the study

    If applicable, pregnancy tests will be conducted regularly

  5. Step 5

    Follow-up period

    Your health will continue to be monitored after treatment completion

    Follow-up visits will assess your long-term response to treatment

    The study will continue until April 2028

Who can join the trial?

15 criteria

  • Age 18 years or older at the time of signing the consent form
  • Must be able to provide signed informed consent and follow study requirements
  • Have an ECOG performance status of 0 to 1 (meaning able to perform daily activities with minimal assistance)
  • Confirmed diagnosis of advanced non-squamous non-small cell lung cancer (stage IIIb/IV or recurring)
  • Have measurable tumors according to RECIST criteria (standard way to measure tumor changes)
  • Show evidence that disease has progressed despite previous treatment with:
    • Anti-PD(L)1 therapy (a type of immunotherapy) and platinum chemotherapy, or
    • Standard immunotherapy without chemotherapy
    • For women who can become pregnant:
      • Must have negative pregnancy test during screening
      • Agree to regular pregnancy testing throughout the study
      • Use effective birth control during study and for 4 months after
      • Must not donate eggs during this period
      • For men participating in the study:
        • Must use barrier contraception (condom plus spermicide)
        • Cannot donate sperm during study and for 3 months after
        • If partner can become pregnant, must ensure partner uses effective birth control
        • Must use barrier protection if partner is pregnant or breastfeeding

Who cannot join the trial?

15 criteria

  • Prior treatment with docetaxel (a chemotherapy drug) for advanced lung cancer
  • History of autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions including uncontrolled high blood pressure or recent heart attack
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
  • Significant liver problems or abnormal liver function tests
  • Pregnant or breastfeeding women
  • Known allergic reactions to any of the study medications
  • Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers)
  • Major surgery within 4 weeks before starting the study
  • Serious lung conditions besides cancer, such as interstitial lung disease (scarring of lung tissue)
  • HIV, hepatitis B, or hepatitis C infection
  • Unable to swallow oral medications
  • Life expectancy less than 3 months
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Investigated drugs

  • Roginolisib

    is a new investigational medication that targets specific pathways involved in cancer growth. It is being studied as a treatment for advanced non-small cell lung cancer in patients who have not responded well to previous treatments.

  • Dostarlimab

    is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking certain proteins that cancer cells use to hide from the immune system.

  • Docetaxel

    is a chemotherapy medication that works by stopping cancer cells from growing and dividing. It has been used for many years to treat various types of cancer, including lung cancer. In this trial, some patients may receive this medication while others may not.

What is already known about the treatment

  • Roginolisib

    An investigational medication being studied in clinical trials for advanced non-squamous non-small cell lung cancer (NSCLC). This drug is administered in combination with dostarlimab and potentially with docetaxel for patients who have progressed after standard immunotherapy and chemotherapy treatments. It works by targeting specific cellular pathways involved in cancer growth, with a particular focus on affecting regulatory T cells (Tregs) in the blood.

  • Dostarlimab

    An immunotherapy medication administered intravenously that belongs to the class of PD-1 inhibitors. It works by helping the immune system recognize and attack cancer cells by blocking certain proteins that prevent T cells from identifying cancer cells. This medication is being studied in combination with roginolisib for treating advanced non-squamous NSCLC in patients who have previously received standard treatments.

  • Docetaxel

    A chemotherapy medication administered intravenously that belongs to the taxane family of drugs. It works by disrupting the cell division process in cancer cells, preventing them from multiplying and spreading. In this clinical trial, it is being evaluated as an optional combination treatment with roginolisib and dostarlimab for advanced non-squamous NSCLC patients.

Investigated diseases

Non-small cell lung cancer (NSCLC) - A type of lung cancer that begins in the cells of the lungs and gradually forms tumors. It develops when cells in the lungs begin to grow uncontrollably, specifically in the non-squamous tissue. The disease typically progresses slowly compared to other types of lung cancer. In advanced stages, the cancer cells spread beyond their original location to other parts of the body. Non-squamous NSCLC refers to specific cell types, including adenocarcinoma and large cell carcinoma. This condition affects the lungs' ability to function normally, potentially impacting breathing and oxygen exchange.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517741-14-00Protocol codeIOA-244-202Estimated enrolment51 patientsSponsoriOnctura SA

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).