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Study on the Effectiveness of Atezolizumab, Carboplatin, and Nab-Paclitaxel in Patients with 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), 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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Thoraxklinik Heidelberg gGmbH Heidelberg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
22.02.2021

Trial locations

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.

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.

Trial ID:
2024-516590-75-00
Protocol code:
IReP
Trial Phase:
Therapeutic exploratory (Phase II)

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