CA209-77T - Nivolumab before & surgery in NSCLC
Research type
Research Study
Full title
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
IRAS ID
266429
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-000262-38
Clinicaltrials.gov Identifier
41078, NIHR Reference Number
Duration of Study in the UK
4 years, 11 months, 9 days
Research summary
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 16 in the UK.
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.REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1184
Date of REC Opinion
20 Aug 2019
REC opinion
Further Information Favourable Opinion