CA209-9TN - Nivolumab as Adjuvant Therapy in NSCLC
Research type
Research Study
Full title
A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention with Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants with ctDNA-detected Minimal Residual Disease after Surgical Resection
IRAS ID
254638
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-003719-23
Clinicaltrials.gov Identifier
40045, NIHR Reference Number
Duration of Study in the UK
4 years, 10 months, 21 days
Research summary
Non-small cell lung cancer (NSCLC) remains the leading cause of cancer-related deaths.
Currently, surveillance for disease recurrence after curative therapy is done via serial radiographic imaging. But this can only detect macroscopic recurrence. The majority of deaths are due to the development of metastases, presumably present as micro-metastases at surgical resection.
Therefore, a test that detects minimal residual disease (MRD) before the disease becomes macroscopic is an unmet medical need. This can be done by testing for circulating tumour DNA (ctDNA) in a patient’s blood.
The main purpose of the study is to see if nivolumab added to the standard of care (SOC) will extend survival without disease recurrence in patients where MRD (ctDNA) is detected.
Nivolumab is a type of immunotherapy which stimulate the body’s own immune system to attack cancer cells. It is now approved in the US and Europe to treat advanced NSCLC in patients who have already had platinum-based chemotherapy.
In earlier trials in NSCLC patients nivolumab added to chemotherapy did not present additional toxicity and the combined treatment presents potential benefits on their combined mode of actions.
In this trial, patients will undergo pre-screening tests to check that it is safe for them to take part in the trial. MRD will be measured after surgery and only the patients with positive MRD will be screened into the study (approximately 20%). The suitable patients will be randomly allocated to receive either nivolumab plus SOC (Chemotherapy or Observation) or SOC alone.
Patients will undergo the following procedures during the study: surgery (standard of care), CT/MRI scans, physical exams, blood sampling for routine safety testing and study specific testing and tumor tissue biopsy.
60 patients are to be treated in the study with approximately 21 to be treated in the UK. The study is sponsored by Bristol-Myers Squibb.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0032
Date of REC Opinion
18 Mar 2019
REC opinion
Further Information Favourable Opinion