Brief Summary
This study is designed to test the potential activity/benefit, safety and feasibility of adding a drug commonly used for bone protection (denosumab) to an immunotherapya treatment that uses a person's immune system to fight cancer drug (nivolumab) before surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence in patients with non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (NSCLC) for whom surgery has been recommended.
Intervention/Treatment
- Drug: Nivolumab
- Drug: Denosumab
Inclusion Criteria
- Histological or cytological diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of NSCLC.
- Baseline histological specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) from primary tumor (and locoregional lymph nodea small lump or mass of tissue in your body metastasiswhen the cancer has spread to other parts of the body, also known as mets if clinically suspected) must be available for all patients.
- Primary tumor must be measurable on CT scan (RECIST v.1.1 criteria).
- Stage IA (>2cm) – IIIA confirmed by FDG-PET scan (it is strongly recommended that mediastinal nodal status in patients with N2 nodes is pathologically confirmed). Stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas is according to 8th edition UICC/AJCC 2017.
- Considered to be surgically resectable by thoracic surgeon.
- No prior therapy for NSCLC.
- Age greater than or equal to 18 years.
- ECOG Performance Status 0-1.
- Peripheral neuropathy no worse than gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells I.
- Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive method during the trial and for 3 months after the completion of chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells.
- Adequate organ function including the following:
- Expected FEV1 following surgery greater than or equal to 1.0 L/sec.
- Adequate bone marrowsoft, spongy tissue found in bones that makes blood cells reserve: ANC at least 1.5 x 109/L, plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding at least 100 x 109/L, haemoglobin at least 100 g/L.
- Hepatic: bilirubin at least 1.5 times ULN; ALP, AST and/or ALT at least 3 times ULN.
- Renal: creatinine clearance at least 60 mL/min (calculated). If the creatinine clearance is between 50 and 60 mL/min, then determination of glomerular filtration rate by nuclear medicinea specialised area of radiology that involves the use of radioactive substances in the diagnosis and treatment of disease scan may be carried out and this result used for eligibility.
- Ability to give written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..