Study on Ceralasertib, Oleclumab, and Monalizumab for Advanced Non-Small Cell Lung Cancer Patients Resistant to PD-1 Inhibitors

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What is this study about?

This clinical trial is focused on studying treatments for advanced non-small cell lung cancer, a type of lung cancer that is common and can be challenging to treat, especially when it becomes resistant to certain therapies. The study is exploring the effectiveness of different treatment strategies, including combinations of medications. One of the main treatments being tested is a combination with a PD-L1 inhibitor called Durvalumab, which is a type of medication that helps the immune system fight cancer. This is compared to Docetaxel, a standard chemotherapy drug used for treating this type of cancer.

The trial involves several experimental medications, including Ceralasertib (also known as AZD6738), which is taken as a tablet and works by inhibiting a protein involved in cancer cell repair. Another medication being tested is Oleclumab (also known as MEDI9447), which is given through an infusion and is designed to target specific proteins on cancer cells. Additionally, Monalizumab (also known as IPH2201) is being studied, which is another infusion-based treatment that helps the immune system recognize and attack cancer cells. The purpose of the study is to assess the anti-tumor activity of these experimental strategies in patients who have not responded to previous treatments.

Participants in the study will receive one of these treatments or a placebo, and their progress will be monitored over a period of time to see how well the cancer is controlled. The study aims to determine the effectiveness of these treatments in controlling the disease and improving patient outcomes. The trial is designed to provide valuable information on new potential treatment options for patients with advanced non-small cell lung cancer who have developed resistance to existing therapies.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Eligibility criteria include a confirmed diagnosis of advanced non-small cell lung cancer, age over 18, and specific health conditions such as adequate organ function.

2 treatment assignment

Participants are assigned to one of the treatment groups. The study aims to compare the effectiveness of different treatment strategies involving a combination of medications.

3 medication administration

Participants receive medications according to their assigned group. The medications include ceralasertib, oleclumab, monalizumab, durvalumab, docetaxel, and savolitinib.

Ceralasertib and savolitinib are administered orally as film-coated tablets.

Oleclumab, monalizumab, and durvalumab are given through intravenous infusion.

Docetaxel is administered intravenously.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes physical examinations, imaging tests, and laboratory tests.

The primary goal is to determine the 12-week disease control rate, while secondary goals include measuring the proportion of patients with complete or partial response and progression-free survival.

5 completion of study

The study is expected to conclude by October 2025. Participants will have a final assessment to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

Must be able and willing to sign a document called an informed consent form, which means you agree to follow the study’s rules and procedures.
For women, must either be post-menopausal or have a negative pregnancy test if pre-menopausal. Post-menopausal means not having a period for 12 months without another medical reason.
Women must not be breastfeeding.
Women and men who can have children must agree to use very effective birth control methods during the study and for 6 months after the last study drug. This includes methods like hormonal injections, certain devices placed in the uterus, or surgical procedures like vasectomy or hysterectomy. Using condoms or not having sex at all are also options.
Must be over 18 years old.
Must have a confirmed diagnosis of advanced or returning non-small cell lung cancer (NSCLC). This includes both squamous and non-squamous types, but not a mix with small cell lung cancer.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well you can carry out daily activities.
Must weigh more than 35 kg (about 77 pounds).
Must show signs of cancer progression after using certain cancer drugs (PD-1 or PD-L1 inhibitors) for more than 6 weeks but less than 18 weeks. No other treatments should have been given between the last immunotherapy and joining this study.
If you have certain genetic changes in your cancer (like EGFR, ALK, or ROS1), you should have already tried specific treatments for those changes.
If you have cancer that has spread to the brain (central nervous system metastases), it must have been treated, and you should not have any symptoms. You should not be receiving treatment like surgery, radiation, or steroids for it, and it should be at least 14 days since the last treatment.
Must have proper functioning of organs and bone marrow, which includes having enough red blood cells, white blood cells, and platelets, as well as normal liver and thyroid function.

Who Cannot Join the Study?

Patients who have a different type of cancer than non-small cell lung cancer cannot participate. This type of cancer affects the lungs and is not the same as other lung cancers.
Patients who have not previously been treated with PD-1/PD-L1 monotherapy are excluded. This is a type of treatment that helps the immune system fight cancer.
Patients who are not in the age range specified for the study cannot join. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or have certain health conditions, are not eligible.
Both male and female patients are eligible, but those who do not meet other criteria will be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Cwxiji Lmsq Bpfmlp	Lyon	France
Asrvoljvjd Pxrxeaxr Hjobwipc Dg Mqliipzyg	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.10.2019

Trial locations

Investigated drugs:

Durvalumab is an immune therapy used in this trial. It works by blocking a protein called PD-L1, which can help the immune system recognize and attack cancer cells more effectively. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced non-small cell lung cancer who have not responded to previous treatments.

Docetaxel is a type of chemotherapy used in this trial. It works by interfering with the growth and division of cancer cells, which can help slow down or stop the progression of the disease. This medication is being used as a standard treatment to compare the effectiveness of the new immune therapy strategies being tested in the study.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body if not managed. The disease progresses through stages, beginning with localized tumors and potentially advancing to more widespread involvement of the lungs and other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the cancer advances, it may lead to more severe respiratory issues and general health decline. Early detection and monitoring are crucial for managing its progression.

Trial ID:

2024-515532-72-00

Protocol code:

PIONeeR TRIAL

NCT ID:

NCT03833440

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ceralasertib, Oleclumab, and Monalizumab for Advanced Non-Small Cell Lung Cancer Patients Resistant to PD-1 Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?