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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Virgen del Rocío University Hospital	Sevilla	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Izpzczps Cbwgnv Dmaeptremahprpxjf	L'hospitalet De Llobregat	Spain
Unjpqbvhgh Oz Akjfoev	Edegem	Belgium
Iubhsuol Reopdtdug Pne Li Sxpisn Doz Tptrmz Dsvf Aynqoyl Idot Snmdbh	Meldola	Italy
Aehlcoc Omrctqxdyra Ujravytbrszgn Szidwc	Siena	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	19.03.2025
Italy	Not recruiting	19.03.2025
Spain	Not recruiting	19.03.2025

Trial locations

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.

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 ID:

2024-517741-14-00

Protocol code:

IOA-244-202

Trial Phase:

Human Pharmacology (Phase I) – Other

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?