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Study Comparing Chemotherapy with Nivolumab to Chemotherapy Alone for Patients with 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 treatments for non-small cell lung cancer that can be completely removed by surgery. The study involves comparing two different treatment approaches. One group of participants will receive a combination of chemotherapy and a medication called nivolumab, which is also known by its code name BMS936558. The other group will receive chemotherapy along with a placebo. After surgery, participants will continue to receive either nivolumab or a placebo.

The purpose of this study is to evaluate the effectiveness of these treatments in improving the time participants remain free from cancer-related events. Participants will undergo a series of treatments and follow-ups over a period of time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving nivolumab or the placebo during the trial. This helps ensure the results are unbiased and reliable.

Throughout the study, participants will receive their treatments through intravenous infusions, which means the medication is given directly into a vein. The study aims to provide valuable information on whether adding nivolumab to chemotherapy before and after surgery can improve outcomes for patients with resectable non-small cell lung cancer. The trial will also monitor the safety and any side effects of the treatments to ensure the well-being of the participants.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participants will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

  2. Step 2

    Neoadjuvant treatment

    Participants will receive neoadjuvant chemotherapy, which is treatment given before surgery. This involves receiving medications through an intravenous (IV) line, which means the medication is delivered directly into a vein.

    The medications used in this phase may include carboplatin, paclitaxel, cisplatin, docetaxel, and pemetrexed. The specific combination and dosage will depend on the group assignment.

    In addition to chemotherapy, some participants will receive nivolumab, an immunotherapy drug, while others will receive a placebo, which is a substance with no active medication. This phase lasts for a specified period, typically several weeks, depending on the treatment plan.

  3. Step 3

    Surgical resection

    After completing the neoadjuvant treatment, participants will undergo surgery to remove the lung cancer. This is known as surgical resection. The goal is to remove all visible cancer from the lung.

  4. Step 4

    Adjuvant treatment

    Following surgery, participants will receive adjuvant treatment, which is additional therapy to help prevent cancer from returning. This may include nivolumab or a placebo, depending on the group assignment.

    The adjuvant treatment is administered through an IV line and continues for a specified duration, which will be communicated by the healthcare team.

  5. Step 5

    Follow-up and monitoring

    Participants will have regular follow-up visits with the healthcare team to monitor their health and the effects of the treatment. This includes physical exams, imaging tests, and laboratory tests.

    The follow-up period is designed to track the participant's recovery and any potential side effects from the treatment.

Who can join the trial?

6 criteria

  • Participants must have a type of lung cancer called Stage IIA to IIIB non-small cell lung carcinoma (NSCLC) that can be surgically removed.
  • Participants must not have cancer that has spread to the brain (no brain metastasis).
  • Participants must not have received any previous treatment for NSCLC (treatment-naive).
  • Participants must be able to provide a sample of their tumor through surgery or a biopsy for testing (biomarkers).
  • Participants must have a performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest. This is measured by the Eastern Cooperative Oncology Group (ECOG).
  • Participants of all genders are eligible.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer that is not resectable Stage II-IIIB Non-small cell lung cancer cannot participate. Resectable means that the cancer can be removed by surgery.
  • Patients who have had another cancer in the past, unless it was a type of skin cancer called basal cell carcinoma or squamous cell carcinoma, or a type of cervical cancer called cervical carcinoma in situ, which have been treated successfully.
  • Patients who have had a heart attack or severe heart problems in the last 6 months cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate. Uncontrolled means that the blood pressure is not being managed well with medication or lifestyle changes.
  • Patients with an active infection that requires treatment with antibiotics cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days cannot participate.
  • Patients with a known allergy to the study medication or its ingredients cannot participate.
  • Patients with a history of drug or alcohol abuse within the last 12 months cannot participate.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.
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Investigated drugs

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Nivolumab is being used to see if it can improve the outcomes for patients with a specific type of lung cancer when given before and after surgery.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating resectable Stage II-IIIB non-small cell lung cancer. The main therapeutic use of Nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which can help the immune system to better fight cancer. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the body's natural defenses against cancer.

Investigated diseases

Non-small cell lung cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the epithelial cells lining the lungs and is characterized by the formation of malignant tumors. The disease progresses as the cancer cells grow and spread to nearby tissues and organs, potentially reaching distant parts of the body through the bloodstream or lymphatic system. In its early stages, NSCLC may not cause noticeable symptoms, but as it advances, individuals may experience persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary significantly among individuals, influenced by factors such as the cancer's subtype, stage at diagnosis, and overall health of the patient.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502658-15-00Protocol codeCA209-77TEstimated enrolment750 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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