Not recruiting

Study on the Effectiveness of Atezolizumab, Carboplatin, and Nab-Paclitaxel in Patients with Resectable Non-Small Cell Lung Cancer

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically in its resectable stages II, IIIA, and select IIIB. The study aims to evaluate the effectiveness of a treatment combination that includes Atezolizumab, Carboplatin, and nab-Paclitaxel. Atezolizumab is an immunotherapy drug that helps the immune system fight cancer cells, while Carboplatin and nab-Paclitaxel are chemotherapy drugs that work to stop the growth of cancer cells.

The purpose of this study is to assess how patients with NSCLC respond to this combination of treatments before undergoing surgery intended to remove the cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will follow a specific schedule where patients will receive the treatment over a period of time before their planned surgery.

Throughout the study, researchers will monitor the response of the cancer to the treatment by looking at changes in tumor size and other indicators. The study will also track the overall health and survival of the participants for a period after the treatment and surgery. This research aims to provide insights into how well this combination of drugs works in treating NSCLC and to help predict which patients might benefit the most from this approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of three medications: atezolizumab, carboplatin, and paclitaxel albumin-bound.
These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
Step 2
Medication schedule
Atezolizumab is administered at a dose of 1,200 mg. The frequency and duration of this medication are determined by the study protocol.
Carboplatin is provided as a solution for infusion, with the dosage and schedule specified by the study guidelines.
Paclitaxel albumin-bound is given as a dispersion for infusion, with the dosage and frequency outlined in the study plan.
Step 3
Monitoring and assessment
Throughout the treatment, regular monitoring is conducted to assess the response to the medications.
The primary goal is to evaluate the reduction in tumor size and the presence of viable tumor cells.
Step 4
Surgery preparation
After completing the medication regimen, preparation for surgery is undertaken.
The surgery aims to remove the lung cancer with curative intent, following the neoadjuvant treatment.
Step 5
Post-surgery follow-up
Following surgery, a follow-up period of 24 months is planned to monitor overall survival and event-free survival.
This includes regular check-ups and assessments to ensure recovery and evaluate long-term outcomes.

Who can join the trial?

20 criteria

Willing and able to sign a written informed consent form.
Females must have a negative pregnancy test at the start and agree to ongoing testing during the study and after the study ends.
Males must agree to use a condom during sexual contact with a pregnant female or a female who can become pregnant while in the study and for 6 months after stopping treatment.
Must have proper kidney, liver, and bone marrow function.
Absolute neutrophil count (a type of white blood cell) must be greater than 1500 per microliter.
Platelet count must be at least 100,000 per microliter.
Hemoglobin (a protein in red blood cells) must be at least 9 grams per deciliter, even if it is after a blood transfusion.
International normalized ratio (INR), a measure of blood clotting, must be 1.4 or less if not on blood thinners; if on blood thinners, INR can be up to 3.0.
Activated partial thromboplastin time (aPTT), another measure of blood clotting, must be 1.5 times the normal limit or less if not on blood thinners; if on blood thinners, aPTT can be up to 2.5 times the normal limit.
Bilirubin, a substance made by the liver, must be less than 1.5 times the normal limit; for those with Gilbert disease, it can be up to 3 times the normal limit.
ALT and AST, enzymes that show liver function, must be less than 2.5 times the normal limit.
Must be 18 years or older and have signed and dated the informed consent.
Creatinine, a waste product in the blood, must be 1.5 times the normal limit or less, or creatinine clearance (a measure of kidney function) must be more than 60 ml/min if creatinine is above 1.5 times the normal limit; if creatinine is 1.5 times the normal limit or less, creatinine clearance must be more than 30 ml/min.
Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1, indicating the ability to carry out daily activities.
Must have non-squamous non-small cell lung cancer (NSCLC) at certain stages (II, IIIA, or select IIIB) confirmed by a tissue sample.
The cancer must be considered removable with surgery aimed at curing it, as determined by a thoracic surgeon after proper imaging tests.
Must have adequate lung and heart function for the planned lung surgery according to German guidelines.
The disease must be measurable by specific criteria used to evaluate tumors.
Must have enough tissue sample from the primary tumor before starting the treatment.
Females who can become pregnant must agree to use effective birth control with a failure rate of 1% or less, starting 28 days before therapy and continuing during the study and for 120 days after the last dose of study medication.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than lung cancer.
Patients who are not in the age range specified for the study.
Patients who are not able to undergo surgery with the intent to cure the cancer.
Patients who have medical conditions that make it unsafe to receive the study treatments.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have serious infections or other health issues that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Atezolizumab
is an investigational treatment used in this study. It is a type of immunotherapy that helps the body's immune system to fight cancer cells. In this trial, it is given to patients before surgery to see if it can improve the response to treatment in lung cancer.
Carboplatin
is a chemotherapy drug used in this study. It works by stopping the growth of cancer cells. It is used in combination with other medications to enhance the overall effectiveness of the treatment.
Nab-Paclitaxel
is another chemotherapy drug included in this trial. It is a form of paclitaxel that is bound to a protein called albumin, which helps it to be delivered more effectively to the cancer cells. It is used alongside other treatments to help shrink the tumor before surgery.

What is already known about the treatment

Atezolizumab
This medication is administered intravenously and is currently being studied for its effectiveness in treating non-small cell lung cancer (NSCLC). It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells more effectively. Atezolizumab is classified as a monoclonal antibody and is primarily used in cancer immunotherapy.
Carboplatin
Administered intravenously, Carboplatin is a chemotherapy drug used in the treatment of various cancers, including lung cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Carboplatin is classified as a platinum-based chemotherapy agent and is well-established in medical literature for its role in cancer treatment.
Nab-Paclitaxel
This medication is given intravenously and is used in the treatment of several types of cancer, including lung cancer. Nab-Paclitaxel is a formulation of the chemotherapy drug paclitaxel, which works by stabilizing microtubules and inhibiting cell division. It is classified as a taxane and is known for its ability to target cancer cells more effectively with reduced side effects compared to traditional paclitaxel.

Investigated diseases

Lung cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung's ability to provide oxygen to the bloodstream. The disease can spread to other parts of the body through the lymphatic system or bloodstream. Lung cancer is often categorized into two main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being more common. The progression of lung cancer can vary, with some tumors growing slowly and others spreading quickly.