About this trial
This is a multicentre, phase 3 study in patients with non-small cell lung cancer. This study will look to see if treatment with nivolumab + chemotherapy given before surgery followed by a further year of treatment with nivolumab/placebo treatment after surgery will significantly improve survival rate when compared to chemotherapy alone. 452 patients will take part in this study with 6 in Ireland.
Patients will be randomly assigned to 12 weeks of pre-surgery treatment:
• Arm A: nivolumab + chemotherapy,
• Arm B: placebo + chemotherapy alone.
All patients will be on chemotherapy before surgery so this part of the treatment is open-label (meaning we know what they are taking). However, the investigational drug (nivolumab) will be blinded. This means that neither the patient nor study doctor will know if they are taking the real Nivolumab or a placebo (a dummy treatment which looks like the real thing but contains no active ingredients). Chemotherapy and Nivolumab/placebo are given every 3 weeks through a vein.
After surgery, patients on arms A and B will go onto maintenance treatment for 1 year. Patients will have the following procedures: surgery, at least 1 biopsy (a tissue sample taken during surgery), vital signs (temperature, heart rate and blood pressure), lung function tests, scans, physical exams, ECGs and blood sampling. They will also have to complete questionnaires regularly.
After surgery, patients will receive the drugs for 1 year (Nivolumab/matching placebo every 4 weeks through a vein) or until they withdraw their consent (meaning they no longer want to take part in the study); can no longer tolerate the study treatment or their cancer gets worse. They will have follow-up visits after the end of their treatment. These visits are mainly to check the patient is well and not suffering any ill effects from the treatment.
Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
Where’s this trial being run?
Tallaght University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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For more detailed informationClick Here
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
|Principal Investigator:||Dr Fergal Kelleher|
|Global Recruitment Target:||452|
|Ireland Recruitment Target:||6|