Study of Atezolizumab and Chemotherapy for Patients with Non-Resectable Non-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 non-small cell lung cancer (NSCLC). The study will explore the effects of a treatment that includes a medication called Atezolizumab, which is also known by its code name RO5541267. Atezolizumab is given as a solution through a vein, a method known as intravenous infusion. The treatment plan involves using Atezolizumab along with chemotherapy and a combination of chemotherapy and radiation therapy. After this initial treatment, Atezolizumab will be continued as a maintenance therapy to help manage the cancer.

The purpose of this study is to evaluate how effective this treatment is in preventing the cancer from getting worse over a period of 12 months. Participants in the study will receive the treatment and be monitored to see how their cancer responds. The study will also look at how long patients live without the cancer progressing and assess the overall safety and tolerability of the treatment.

Participants will undergo various assessments throughout the study to track their health and the status of their cancer. These assessments will help researchers understand the treatment’s impact on the cancer and any side effects that may occur. The study aims to provide valuable information on the potential benefits of using Atezolizumab in combination with other therapies for patients with non-small cell lung cancer.

1 induction phase

During this phase, the patient receives a combination of atezolizumab and chemotherapy. Atezolizumab is administered as a solution for infusion through a vein (intravenous use).

The specific dosage and frequency of administration are determined by the healthcare provider based on individual patient needs and response to treatment.

2 chemo-radiotherapy phase

Following the induction phase, the patient undergoes a combination of chemotherapy and radiotherapy. This phase aims to target the cancer cells more effectively by combining these two treatment modalities.

The duration and specific regimen are tailored to the patient’s condition and response to the initial treatment.

3 maintenance therapy

After completing the chemo-radiotherapy phase, the patient continues with maintenance therapy using atezolizumab alone.

This phase is designed to help maintain the response achieved from the previous treatments and to prevent cancer progression.

4 progression-free survival assessment

Throughout the trial, the patient’s progression-free survival (PFS) is monitored. PFS refers to the length of time during and after treatment that the patient lives with the disease without it getting worse.

Assessments are conducted at regular intervals to evaluate the effectiveness of the treatment according to specific criteria.

5 safety and tolerability evaluation

The safety and tolerability of atezolizumab in combination with chemotherapy and as a maintenance treatment are continuously evaluated.

This involves monitoring for any side effects or adverse reactions to ensure the patient’s well-being throughout the trial.

Who Can Join the Study?

Must be a male or female aged between 18 and 80 years old.
Must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities.
Must have non-small cell lung cancer (NSCLC) that is confirmed by tests and is at a stage that cannot be removed by surgery (Stage IIIA-IIIB-IIIC).
Must have a PET-CT and brain CT or MRI scan to confirm there is no cancer spread to distant parts of the body.
Mediastinal involvement (cancer in the area between the lungs) can be considered without a biopsy if the lymph node mass has no clear edges.
Must not have had any previous treatment with cancer drugs or chest radiotherapy for this type of lung cancer.
Must have at least one area of cancer that can be measured by a CT scan, as defined by specific criteria (RECIST v1.1).
Must have adequate blood and organ function, confirmed by lab tests done within 14 days before joining the study.
Must have good lung function, with specific test results: FEV1 (a lung function test) greater than 50% of normal and DLCO (a test for lung gas exchange) greater than 40% of normal.
No more than 35% of the total lung volume should receive more than 20 Gy of radiation, or the maximum diameter should not exceed 7 cm.
Female patients who can have children must agree to use highly effective birth control methods during the study and for 6 months after the last treatment dose.
Male patients with female partners who can have children must agree to use highly effective birth control methods during the study and for 6 months after the last treatment dose. They should not donate sperm during this time.
Oral contraception should be combined with another method of birth control due to possible interactions with study drugs. Male patients must use a condom if their partner can have children.
Women who are not postmenopausal or surgically sterile must have a negative pregnancy test within 8 days before starting the study drug.
All patients must be informed about the experimental nature of the study and sign a written consent form before any study-related procedures.

Who Cannot Join the Study?

Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
Patients who have had another cancer in the past, unless it was a type that is not expected to come back, cannot participate.
Patients who have had a serious heart condition in the past 6 months cannot participate.
Patients with an active infection that requires treatment with antibiotics cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have an allergy to the study drugs cannot participate.
Patients who have received another experimental treatment in the last 4 weeks cannot participate.
Patients with a condition that affects their ability to understand the study or follow instructions cannot participate.
Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.
Patients who have had a major surgery in the past 4 weeks cannot participate.

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 Hm Sanchinarro	Madrid	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Poqy Tyeff Hnaxxaha Uvnodycrtquk	Sabadell	Spain
Hxtczyzh Dc La Scmpg Cfwm I Sxal Pqn	Barcelona	Spain
Igyzhqwv Cchszr Daddrpjsunwrgdwyh	L'hospitalet De Llobregat	Spain
Hykbkaow Ulnajfmjqjeuh dm A Cnrciv	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	10.06.2024

Trial locations

Investigated Drugs:

Atezolizumab

Atezolizumab is an immunotherapy drug used in this trial. It works by helping the immune system recognize and attack cancer cells. In this study, it is given to patients with non-small cell lung cancer that cannot be removed by surgery. Atezolizumab is used in combination with other treatments to improve the chances of controlling the cancer.

Induction Chemotherapy refers to the initial phase of chemotherapy treatment aimed at reducing the size of the tumor. In this trial, it is used alongside Atezolizumab to help shrink the cancer before further treatment.

Chemo-Radiotherapy is a combination of chemotherapy and radiation therapy. This approach is used to enhance the effectiveness of treatment by using chemotherapy to make cancer cells more sensitive to radiation. In this trial, it is part of the treatment plan to control the cancer more effectively.

Atezolizumab Maintenance Therapy is the continued use of Atezolizumab after the initial treatment phases. The goal of maintenance therapy is to keep the cancer under control and prevent it from growing or spreading further.

Investigated Diseases:

Non-small cell lung cancer

Non-small cell lung cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2024-514803-33-00

NCT ID:

NCT04776447

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Atezolizumab and Chemotherapy for Patients with Non-Resectable Non-Small Cell Lung Cancer

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