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Study on Atezolizumab with Platinum-Based Chemotherapy for Patients with Early-Stage Resectable Non-Small Cell Lung Cancer

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What is this trial about?

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

This clinical trial is focused on studying the treatment of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer that can be surgically removed. The study involves the use of a medication called atezolizumab, which is an immunotherapy drug that helps the immune system fight cancer. Atezolizumab will be used in combination with platinum-based chemotherapy, which includes drugs like cisplatin and carboplatin. These chemotherapy drugs contain platinum and are used to kill cancer cells. The study also involves a placebo, which is a substance with no active medication, to compare the effects of atezolizumab.

The purpose of the study is to evaluate how effective and safe the treatment is when given before surgery (neoadjuvant treatment) and followed by additional atezolizumab after surgery (adjuvant treatment). Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which participants will receive the treatment and be monitored for any changes in their condition.

Throughout the study, the main focus will be on how long participants remain free from cancer events, which is known as event-free survival. The study will also look at other outcomes, such as the overall survival of participants and any side effects they may experience. The goal is to determine if the combination of atezolizumab and platinum-based chemotherapy is more effective than chemotherapy alone in treating early-stage resectable NSCLC.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The initial phase involves receiving a combination of medications through an intravenous infusion. This includes atezolizumab or a placebo, along with platinum-based chemotherapy drugs such as cisplatin or carboplatin, and other drugs like pemetrexed or gemcitabine.

    The medications are administered in cycles, with each cycle lasting approximately three weeks. The exact number of cycles will depend on the specific treatment plan.

  2. Step 2

    Surgical intervention

    After completing the initial treatment phase, a surgical procedure is planned to remove the lung cancer. The surgery aims to achieve a complete removal of the tumor with curative intent.

    Eligibility for surgery is determined based on adequate pulmonary, cardiac, hematologic, and end-organ function.

  3. Step 3

    Adjuvant treatment phase

    Following surgery, an additional treatment phase with atezolizumab is conducted. This phase is designed to help prevent the cancer from returning.

    The adjuvant treatment is administered through intravenous infusion at specified intervals, continuing for a duration determined by the treatment plan.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor recovery and assess the effectiveness of the treatment.

    These appointments may include imaging tests, blood tests, and assessments of health-related quality of life.

Who can join the trial?

6 criteria

  • Must be **18 years or older**.
  • Must be able to receive a **platinum-based chemotherapy** treatment. This is a type of cancer treatment that uses drugs containing the metal platinum.
  • Must have a confirmed diagnosis of **Stage II, IIIA, or certain IIIB (T3N2 only) non-small cell lung cancer (NSCLC)**. This means the cancer is in an early stage where it can be surgically removed. The cancer can be of two types: squamous or non-squamous.
  • The cancer must appear as a **solid or subsolid mass** on a CT scan, which is a detailed imaging test. It should not appear as a **purely ground-glass opacity (GGO)**, which is a hazy area seen on the scan.
  • Must be eligible for **R0 resection**, which means surgery can be done with the goal of completely removing the cancer.
  • Must have **adequate lung, heart, blood, and organ function** to safely undergo surgery aimed at curing the cancer. This is determined by tests that check how well the lungs are working, known as **Pulmonary function tests (PFTs)**.

Who cannot join the trial?

10 criteria

  • 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 already received treatment for their lung cancer are not eligible.
  • Patients with serious heart problems cannot join the study.
  • Patients with active infections, such as HIV or hepatitis, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with autoimmune diseases, where the immune system attacks the body, are not eligible.
  • Patients who have had an organ transplant cannot join the study.
  • Patients taking certain medications that affect the immune system are excluded.
  • Patients with a history of severe allergic reactions to the study drugs cannot participate.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate are not eligible.
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Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It is given to patients before surgery to shrink the tumor and after surgery to help prevent the cancer from coming back. It works by blocking a protein that stops the immune system from attacking cancer cells.

  • Platinum-Based Chemotherapy

    refers to a group of chemotherapy drugs that contain the metal platinum. These drugs are used to kill cancer cells or stop them from growing. In this trial, they are combined with atezolizumab to treat lung cancer before surgery.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating early-stage resectable non-small cell lung cancer (NSCLC). It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for atezolizumab is as a neoadjuvant treatment in combination with platinum-based chemotherapy for certain stages of NSCLC. At the molecular level, atezolizumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

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 cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The disease can spread to other parts of the body, including the bones, brain, and liver. Early-stage resectable NSCLC refers to tumors that can be surgically removed, offering a potential for cure if detected early.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504209-35-00Protocol codeGO40241Estimated enrolment452 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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