Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Chemotherapy vs. Nivolumab for 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), which can be surgically removed. The study is comparing two treatment approaches for patients who have had their lung cancer completely removed. One group of patients will receive standard chemotherapy, while the other group will receive a combination of chemotherapy and a medication called nivolumab, also known by its code names BMS936558 and ABP 206. Nivolumab is a type of immunotherapy, which helps the body's immune system fight cancer.

The purpose of the study is to see how well these treatments work in preventing the cancer from coming back. Patients will be randomly assigned to one of the two treatment groups. The study will monitor patients over time to see if the cancer returns, if any new lung cancer develops, or if there are any other health changes. The study will also look at the overall survival of patients, which means the length of time patients live after starting the study, and will track any side effects or health issues that arise during the treatment.

Participants in the study will receive their assigned treatment for up to 12 months. The treatments will be given through an intravenous infusion, which means the medication is delivered directly into a vein. The study aims to provide valuable information on the effectiveness and safety of adding nivolumab to standard chemotherapy for patients with resectable NSCLC.

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, the patient is required to have a confirmed diagnosis of primary non-small cell lung cancer (NSCLC) that is resectable. The cancer must be completely removed through surgery.

    The patient must be classified in stage IB, II, or IIIA according to specific pathological criteria. A minimum of three weeks must have passed since the surgery before the patient can be randomized into the study.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: one receiving adjuvant chemotherapy alone, and the other receiving a combination of chemotherapy and immunotherapy.

    The primary goal is to evaluate the length of time the patient remains free from cancer recurrence or any new lung cancer.

  3. Step 3

    Treatment phase

    For patients in the chemo-immunotherapy group, the treatment includes the administration of nivolumab, a medication given through an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    The treatment phase begins between the third and tenth week after surgery and continues as per the study's schedule.

  4. Step 4

    Follow-up

    Patients are monitored for disease-free survival, which is the time from randomization until any recurrence of cancer or death from any cause.

    Overall survival is also tracked, defined as the time from randomization to death from any cause.

  5. Step 5

    Safety and tolerability assessment

    The study evaluates the safety and tolerability of the treatments by monitoring any adverse events, including serious adverse events and immune-related adverse events.

    Laboratory tests are conducted to identify any abnormalities, and adverse events are graded according to a standardized scale.

Who can join the trial?

14 criteria

  • Patients must have been diagnosed with a type of lung cancer called non-small cell lung cancer, confirmed by a test called a histological test.
  • Patients should be classified in certain stages of cancer (IB, II, or IIIA) after surgery, based on specific guidelines.
  • The cancer must have been completely removed through surgery, following specific guidelines for removing lymph nodes.
  • The type of surgery can include lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Certain other types of surgery are not eligible unless complete removal of cancer is confirmed.
  • Patients should not have received certain types of chemotherapy before surgery.
  • Patients should not have received or be scheduled to receive radiation therapy before or after surgery.
  • At least 3 weeks should have passed since the surgery, and additional treatment should start between the 3rd and 10th week after surgery.
  • Patients should have a performance status of 0-1 on the ECOG scale, which measures daily living abilities.
  • Patients must be 18 years or older.
  • Patients must have normal blood, liver, and kidney function.
  • Patients must agree to participate in the study and provide consent as required by local regulations.
  • Patients must be available for treatment and follow-up visits.
  • Women who can become pregnant must have a negative pregnancy test before starting the study.
  • All sexually active men and women who can become pregnant must use effective birth control during the study and for a specified time after the study ends.

Who cannot join the trial?

4 criteria

  • Patients with a type of lung cancer that cannot be surgically removed.
  • Patients who have had a recurrence of lung cancer, which means the cancer has come back after treatment.
  • Patients who have developed any new lung cancer, even if it is in the other lung.
  • Patients who have passed away from any cause at any known point in time.
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

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

  • Chemotherapy

    is a treatment that uses drugs to kill cancer cells. In this trial, chemotherapy is used as a standard treatment for patients with non-small cell lung cancer (NSCLC) who have had their tumors completely removed. The goal is to eliminate any remaining cancer cells and reduce the risk of the cancer coming back.

  • Chemo-immunotherapy

    combines chemotherapy with immunotherapy. Immunotherapy helps the body's immune system recognize and attack cancer cells more effectively. In this trial, chemo-immunotherapy is being tested to see if it can improve outcomes for patients with NSCLC compared to chemotherapy alone. The aim is to enhance the body's natural defenses against cancer while also using chemotherapy to target and destroy cancer cells.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating resectable non-small cell lung cancer (NSCLC) as part of a chemo-immunotherapy regimen. The main therapeutic indication for nivolumab is to enhance the immune system's ability to fight cancer cells. At the molecular level, it works by blocking the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy used in cancer treatment.

Investigated diseases

Resectable Non-small Cell Lung Cancer – This is a type of lung cancer that can potentially be removed through surgery. It originates in the tissues of the lung, typically in the cells lining the air passages. The disease progresses as cancer cells grow and form tumors, which can spread to nearby tissues and organs. In its early stages, the cancer may not cause noticeable symptoms, but as it advances, it can lead to coughing, chest pain, and difficulty breathing. The progression of the disease can vary, with some cases remaining localized while others may spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513730-38-00Estimated enrolment210 patientsSponsorFundacion GECP

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

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.