Study on the Effectiveness of Paclitaxel, Carboplatin, and Durvalumab for Patients with Extensive Stage 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 Extensive Stage Small Cell Lung Cancer (ES-SCLC). The study is investigating the effectiveness of a combination of treatments, including durvalumab (also known by its code name MEDI4736), paclitaxel, and carboplatin. These medications are given as an infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well this combination of treatments works in patients with ES-SCLC. Participants in the study will receive these medications over a period of time, with durvalumab being administered for up to 48 weeks and the other medications for up to 12 weeks. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study will monitor participants’ health and response to the treatment, including their overall survival and any changes in their quality of life. The goal is to determine if this combination of treatments can improve outcomes for patients with this type of lung cancer. Participants will be closely observed for any side effects or adverse reactions to the medications throughout the study period.

1 initial visit

Upon joining the study, you will attend an initial visit where you will review and sign the informed consent form. This document ensures you understand the study and agree to participate.

During this visit, your eligibility will be confirmed through various assessments, including a review of your medical history and a physical examination.

2 treatment plan discussion

The study team will explain the treatment plan, including the medications you will receive: durvalumab, paclitaxel, and carboplatin. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

You will receive information about the dosage, frequency, and duration of each medication. The treatment schedule will be outlined, and any questions you have will be addressed.

3 treatment administration

You will begin receiving the study medications. Durvalumab is typically administered every three weeks, while paclitaxel and carboplatin are given on a specific schedule as determined by the study protocol.

The duration of the treatment phase will be explained, and you will be monitored closely for any side effects or reactions to the medications.

4 regular follow-up visits

Throughout the study, you will have regular follow-up visits. These visits are important for monitoring your health and the effectiveness of the treatment.

During these visits, you may undergo various tests, such as blood tests and imaging scans, to assess your response to the treatment.

5 end of treatment evaluation

At the end of the treatment period, you will have a final evaluation to determine the overall impact of the study medications on your condition.

This evaluation will include a comprehensive review of your health status and any changes observed during the study.

6 long-term follow-up

After completing the treatment phase, you will enter a long-term follow-up period. This phase is designed to monitor your health over time and gather information on the long-term effects of the treatment.

You will have periodic check-ins with the study team, and any ongoing health concerns will be addressed.

Who Can Join the Study?

Must have signed an informed consent form, agreeing to participate in the study and follow the study procedures.
Men who are sexually active with women who can become pregnant must use effective birth control during treatment and for 6 months after the last dose.
Must have a life expectancy of at least 12 weeks.
Must be covered by national health insurance.
Must have been diagnosed with Small Cell Lung Cancer (SCLC) confirmed by a tissue sample.
Must have Extensive-Stage Disease, meaning the cancer has spread beyond the chest and nearby lymph nodes.
Must have at least one measurable tumor as assessed by a doctor using specific guidelines.
Must be 18 years of age or older.
Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, indicating they are fully active or have some symptoms but do not require bed rest.
Must weigh more than 30 kg (about 66 pounds).
Must have adequate biological functions, including:
- Creatinine clearance (a measure of kidney function) of at least 45 ml/min.
- Hemoglobin (a measure of red blood cells) of at least 9.0 g/dL.
- Neutrophils (a type of white blood cell) of at least 1500/μL.
- Platelets (cells that help with blood clotting) of at least 100,000/μL.
- Bilirubin (a liver function test) of no more than 1.5 times the normal level, except for those with Gilbert syndrome.
- ALT and AST (liver enzymes) of no more than 2.5 times the normal level, or 5 times if there are liver metastases.
Women who cannot become pregnant due to surgery or menopause are eligible. Women who can become pregnant must have a negative pregnancy test before starting treatment and use effective birth control during treatment and for 6 months after the last dose.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Extensive Stage Small Cell Lung Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
Patients who have any other serious medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had another cancer treatment recently that might interfere with the study cannot participate.
Patients who have allergies to the study medications cannot participate.
Patients who have participated in another clinical trial recently cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
HIA Sainte Anne	Toulon	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier De Cholet	Cholet	France
Hopital Tenon	Paris	France
Clinique de l’Europe	Amiens	France
Centre Hospitalier Alpes Leman	74130	France
Centre Hospitalier Pays de Morlaix	Morlaix	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Assistance Publique Hopitaux De Paris	Paris	France
Hopital Europeen Marseille	Marseille	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopitaux Robert Schuman S.A.	Luxembourg	Luxembourg
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Centre Hospitalier Pasteur	Colmar	France
Czvqmu Hkhvbhswltw Uvrnzwtbmvrqj Da Dhhsb	Dijon	France
Cgpaio Hhwafkytjjk dccolcchtdsiwuadh	Abbeville	France
Cg Vfvzigoujpyq Naue Oqrno	Villefranche sur Saône	France
Aqoawkuuft Phyvfyoh Haqpyzwp Dk Mysljhexh	Marseille	France
Bdwtnxkm Ustbyfqzyl Hihwvjng Ccrvhx	Besançon	France
Cklbaw Htpdujrnbyl Rqztregu Unbkumeeoixlb Dk Tctnw	Tours	France
Cximln Hehvkhualcz Roxiuvtc Doyuyhfcrsisjp	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2023
Luxembourg	Not yet recruiting	01.09.2023

Trial locations

Investigated drugs:

Paclitaxel is a type of chemotherapy medication used to treat various types of cancer, including lung cancer. It works by stopping cancer cells from dividing and growing, which can help to slow down or stop the spread of the disease. In this trial, paclitaxel is being used to treat patients with extensive stage small cell lung cancer.

Carboplatin is another chemotherapy drug that is often used in combination with other medications to treat cancer. It works by damaging the DNA of cancer cells, which prevents them from multiplying. This can help to reduce the size of tumors and slow the progression of the disease. In this study, carboplatin is used alongside other treatments to help manage small cell lung cancer.

Durvalumab is an immunotherapy drug that helps the body’s immune system fight cancer. It works by blocking a specific protein that cancer cells use to hide from the immune system. By blocking this protein, durvalumab allows the immune system to better recognize and attack cancer cells. In this clinical trial, durvalumab is being tested to see how well it works in combination with chemotherapy for treating small cell lung cancer.

Investigated diseases:

Small cell lung cancer extensive stage

Extensive Stage Small Cell Lung Cancer – This is a type of lung cancer characterized by small, round cancer cells that multiply quickly and form large tumors. It is called “extensive stage” when the cancer has spread beyond the lung to other parts of the body. The disease progresses rapidly, often involving the liver, bones, and brain. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer spreads, it can cause additional symptoms depending on the organs affected. The progression of the disease can lead to significant changes in a person’s overall health and quality of life.

Trial ID:

2023-504670-38-00

Protocol code:

IFCT-2203 TAXIO

NCT ID:

NCT05856695

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Paclitaxel, Carboplatin, and Durvalumab for Patients with Extensive Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?