This clinical trial is focused on studying the effects of a treatment for elderly patients with advanced Non-Small Cell Lung Cancer (NSCLC). The treatment being tested includes a combination of medications: Atezolizumab, Carboplatin, and Paclitaxel. Atezolizumab is an anti-PDL1 antibody, which is a type of protein designed to help the immune system fight cancer cells. Carboplatin and Paclitaxel are chemotherapy drugs that work by stopping the growth of cancer cells.
The purpose of the study is to determine how effective Atezolizumab is when used alongside Carboplatin and Paclitaxel in improving the overall survival of patients. Participants in the study will receive these medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. The study will compare the survival rates of patients receiving the standard treatment with those receiving the experimental combination of Atezolizumab, Carboplatin, and Paclitaxel.
The study will take place over a period of time, with patients receiving treatment and being monitored for their response to the medication. The goal is to see if the combination of these drugs can help patients live longer and manage their cancer more effectively. The study will also look at other factors such as how long patients live without the cancer getting worse and the overall response to the treatment.
1initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the trial, including the purpose, procedures, and potential risks and benefits. You will be asked to sign a consent form to confirm your understanding and willingness to participate.
A series of tests and assessments will be conducted to confirm your eligibility. These may include blood tests, imaging scans, and a review of your medical history.
2treatment plan discussion
Once eligibility is confirmed, the treatment plan will be discussed. The trial involves the use of three medications: carboplatin, paclitaxel, and atezolizumab. These medications are administered through an infusion, which means they are given directly into your bloodstream through a vein.
The treatment schedule includes monthly administration of carboplatin and weekly administration of paclitaxel. Atezolizumab is also administered as part of the treatment plan.
3treatment phase
During the treatment phase, you will receive the medications according to the schedule discussed. Regular visits to the clinic will be necessary for the infusions and to monitor your health and response to the treatment.
You will be closely monitored for any side effects or changes in your condition. It is important to report any new symptoms or concerns to the medical team promptly.
4follow-up visits
After completing the treatment phase, follow-up visits will be scheduled. These visits are essential to assess your overall health and the effectiveness of the treatment.
Additional tests and assessments may be conducted during these visits to gather information on your progress and any long-term effects of the treatment.
5end of trial
The trial is expected to conclude by September 2026. At the end of the trial, a final assessment will be conducted to evaluate your health status and the outcomes of the treatment.
You will receive information about any further steps or recommendations based on the results of the trial.
Who Can Join the Study?
Must have signed a written informed consent form, which means you agree to participate in the study and understand what it involves.
Must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary lab tests.
Must have a life expectancy of at least 12 weeks.
If you are a male with a female partner who can become pregnant, you must agree to use a highly effective form of birth control during the study and for 6 months after the last treatment. You should not donate sperm during this time.
Must be covered by national health insurance.
If you are a protected adult, you can participate if you can make decisions about your medical treatment.
Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) through specific medical tests.
Must be between 70 to 89 years old.
Must have a performance status of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
Must have cancer that is at stage IIIB, IIIC, or IV, which means it is advanced and cannot be treated with radiation alone.
Must have measurable disease as defined by specific medical criteria, with recent radiological assessment.
Must not have received any prior systemic anticancer therapy for advanced or metastatic disease.
At least 3 weeks must have passed since any major surgery or radiation therapy.
Must have adequate biological functions, which means your body is working well enough to handle the treatment. This includes specific levels of kidney function, blood cells, and liver enzymes.
Who Cannot Join the Study?
Patients who have a different type of cancer other than Non-Small Cell Lung Cancer.
Patients who are not in the age range specified for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition that the study doctors think would make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have had a severe allergic reaction to any of the study drugs or similar drugs in the past.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment.
Patients who have a serious heart condition that is not well controlled.
Patients who have a history of another type of cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread).
Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. Specifically, it blocks a protein called PD-L1, which is found on some cancer cells. By blocking this protein, atezolizumab helps your immune system recognize and attack the cancer cells more effectively. In this trial, atezolizumab is being tested to see if it can improve survival in elderly patients with advanced non-small-cell lung cancer when used alongside other cancer treatments.
Carboplatin is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing. This helps to slow down or stop the spread of cancer in the body. In this trial, carboplatin is used in combination with other treatments to see if it can help improve outcomes for patients with advanced non-small-cell lung cancer.
Paclitaxel is another chemotherapy medication that is used to treat different kinds of cancer, such as lung cancer. It works by interfering with the normal function of microtubules during cell division, which stops cancer cells from dividing and growing. This can help to control the spread of cancer. In this study, paclitaxel is given alongside other treatments to evaluate its effectiveness in improving the survival of elderly patients with advanced non-small-cell lung cancer.
Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. NSCLC often grows and spreads more slowly than small cell lung cancer, which is another major type of lung cancer. Symptoms may include persistent cough, chest pain, and difficulty breathing, which can worsen as the disease advances. The progression of NSCLC can vary significantly among individuals, depending on factors such as the specific subtype and stage at diagnosis.
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