Study Comparing Atezolizumab and Drug Combination with Pembrolizumab and Drug Combination for Patients with Advanced 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 metastatic TTF-1 negative lung adenocarcinoma. The study aims to compare the effectiveness of two different treatment combinations. The first treatment group will receive a combination of atezolizumab, carboplatin, and nab-paclitaxel. The second treatment group will receive pembrolizumab, a type of platinum-based drug, and pemetrexed. These medications are given as solutions through a vein, a method known as intravenous infusion.

The purpose of the study is to compare the survival rates of patients receiving these different treatment combinations. Participants in the study will receive their assigned treatment over a period of up to 12 months. During this time, they will have regular hospital visits for treatment and follow-up examinations to monitor their health and the effects of the treatment.

By participating in this study, researchers hope to gather valuable information that could improve treatment options for patients with this specific type of lung cancer. The study will help determine which combination of medications might offer better outcomes for patients in terms of survival. The results of this study could potentially lead to advancements in the treatment of metastatic TTF-1 negative lung adenocarcinoma.

1 initial visit

Upon joining the study, you will attend an initial visit at the hospital. During this visit, medical staff will review your medical history and perform necessary tests to confirm your eligibility for the trial.

You will receive detailed information about the trial procedures, medications, and potential side effects. It is important to ask any questions you may have at this stage.

2 treatment group assignment

You will be randomly assigned to one of two treatment groups. One group will receive a combination of atezolizumab, carboplatin, and nab-paclitaxel. The other group will receive pembrolizumab, a platinum-based drug, and pemetrexed.

The assignment is random to ensure the study’s scientific validity.

3 treatment administration

You will receive your assigned treatment through an intravenous infusion, which means the medication will be delivered directly into your bloodstream through a vein.

The frequency and duration of the treatment will be explained to you by the medical staff, and it will depend on the specific protocol of the trial.

4 regular monitoring

Throughout the trial, you will have regular hospital visits for monitoring. These visits will include physical examinations, blood tests, and imaging studies to assess your response to the treatment.

It is crucial to attend all scheduled visits to ensure your safety and the collection of accurate data.

5 follow-up visits

After completing the treatment phase, you will continue to have follow-up visits. These visits are designed to monitor your health and any long-term effects of the treatment.

The frequency and duration of follow-up visits will be determined by the study protocol and your healthcare team.

6 end of trial

The trial is expected to conclude by January 1, 2026. At the end of the trial, the results will be analyzed to determine the effectiveness of the treatments.

You will be informed about the overall findings of the study and any implications for your future care.

Who Can Join the Study?

The patient must have provided written informed consent, which means they agree to participate in the study after being informed about it.
The patient must have adequate liver, kidney, and bone marrow function. This includes:
- Hemoglobin (a protein in red blood cells) level of at least 8.0 g/dL.
- Absolute neutrophil count (a type of white blood cell) of at least 1.5 x 10⁹/L.
- Platelets (cells that help with blood clotting) of at least 100 x 10⁹/L.
- Creatinine clearance (a measure of kidney function) of at least 50 mL/min or creatinine level no more than 1.5 times the upper limit of normal.
- Serum bilirubin (a substance made by the liver) no more than 1.5 times the upper limit of normal.
- AST/ALT (liver enzymes) and alkaline phosphatase no more than 2.5 times the upper limit of normal.
- INR/aPTT (blood clotting tests) no more than 1.5 times the upper limit of normal, unless the patient is on blood thinners and the levels are within the therapeutic range.
The patient must be willing and able to follow the study protocol, including attending hospital visits for treatment and follow-up examinations.
Female patients who can have children must use a reliable form of birth control during the study and for 6 months after the last dose. Male patients who are sexually active with women who can have children must also use reliable birth control during the study and for at least 6 months after the last dose. Women who cannot have children and men who are unable to father children do not need to use birth control.
The patient must be 18 years or older at the time of signing the consent form.
The patient must have a confirmed diagnosis of metastatic stage IV non-squamous non-small cell lung cancer (NSCLC).
The patient must have a negative test result for TTF-1 (a protein found in some lung cancer cells).
The patient must have negative test results for EGFR mutations and ALK rearrangements (specific genetic changes in cancer cells). In some cases, treatment may start before these results are available, but if the tests later show positive results, the patient will be withdrawn from the study.
The patient must have a PD-L1 tumor proportion score (TPS) of less than 50% (a measure of a protein that can affect the immune response to cancer).
The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest during the day.
The patient must have measurable lesions according to RECIST v1.1 (a standard way to measure cancer response to treatment).
The patient must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients with a type of lung cancer called metastatic TTF-1 negative lung adenocarcinoma cannot participate. This means the cancer has spread to other parts of the body and lacks a specific protein called TTF-1.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
Both male and female patients can participate, but if a patient does not meet other gender-related criteria, they may be excluded.
Patients who are considered part of a vulnerable population may be excluded. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsmedizin Goettingen	Goettingen	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
HELIOS Klinikum Krefeld GmbH	Krefeld	Germany
Klinikum St Marien Amberg	Amberg	Germany
Dr. Vehling-Kaiser MVZ GmbH	Landshut	Germany
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Ludwig Maximilian University Of Munich	Munich	Germany
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH	Hemer	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Asklepios Klinik Gauting GmbH	Gauting	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Heidelberg University	Mannheim	Germany
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Uxokybjezrmtfvdhxjlpm Etqkl Aei	Essen	Germany
Mxbpnojeyjuzv Vtslvzsiafnpmaowes Tpciyu Gsvg	Bad Homburg	Germany
Ublwokfdyjxetawvsctvl Mfzbyucy Aub	Munster	Germany
Geyrxo Uwmcawrusu Fssnpaqke	Frankfurt	Germany
Kyoljkyd Edijxnwbmkdxymrzgerydzkc Hackauqqzqufnquyy	Essen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.07.2023

Trial locations

Investigated drugs:

Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being used to treat a specific type of lung cancer by boosting the body’s natural defenses to fight the cancer.

Carboplatin is a chemotherapy drug that is used to kill cancer cells. It works by damaging the DNA of the cancer cells, which stops them from growing and dividing. In this trial, it is used to help control the spread of lung cancer.

Nab-Paclitaxel is another chemotherapy medication. It is designed to stop cancer cells from dividing and growing. This medication is used in the trial to help shrink tumors and slow down the progression of lung cancer.

Pembrolizumab is an immunotherapy drug that helps the immune system detect and fight cancer cells. It is used in this trial to treat lung cancer by enhancing the body’s ability to target and destroy cancer cells.

Pemetrexed is a chemotherapy drug that works by interfering with the growth of cancer cells. It is used in this trial to help prevent the cancer from spreading and to reduce the size of tumors.

Platinum refers to a group of chemotherapy drugs that contain platinum, which are used to treat various types of cancer. In this trial, a platinum-based drug is used to help kill cancer cells and control the spread of lung cancer.

Investigated diseases:

Lung adenocarcinoma

Metastatic TTF-1 negative lung adenocarcinoma – This is a type of lung cancer that originates in the glandular cells of the lung and has spread to other parts of the body. It is characterized by the absence of thyroid transcription factor-1 (TTF-1), a protein often found in lung adenocarcinomas. The disease progresses as cancer cells grow uncontrollably and invade surrounding tissues, eventually spreading to distant organs. As the cancer advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The spread of cancer to other parts of the body can lead to additional symptoms depending on the organs affected. The progression of the disease can vary significantly among individuals.

Trial ID:

2023-505054-17-00

Protocol code:

ANTELOPE

NCT ID:

NCT05689671

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Atezolizumab and Drug Combination with Pembrolizumab and Drug Combination for Patients with Advanced Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?