Pancoast's tumour Trials in Disease

Study of Chemotherapy and Nivolumab Before and After Surgery for Patients with Non-Small Cell Lung Cancer in the Upper Lung Area

This clinical trial is testing a treatment approach that combines chemotherapy with an immunotherapy drug called nivolumab (also known by its code name BMS936558) for patients with a Pancoast tumour. The treatment is given both before and after surgery with the goal of completely removing the cancer without any remaining cancer cells.

Main inclusion criteria:

• You must have non-small cell lung cancer with a Pancoast tumour that can be surgically removed
• You should not have received any previous treatment for this cancer
• You must be between 18 and 75 years old
• Your general health status (ECOG performance status) should be between 0 and 2, meaning you are fully active or have some limitations but can still care for yourself
• You must have adequate lung function, with breathing capacity (FEV1) at least 1.2 liters or more than 40% of the predicted value
• Blood tests must show acceptable levels of blood cells, kidney function, and liver function
• A PET/CT scan and possibly a brain scan must confirm the tumour location and check that the cancer has not spread to distant parts of the body
• Women who can become pregnant must have a negative pregnancy test and all sexually active participants must use effective birth control during the study and for 12 months after treatment

Main exclusion criteria:

• The tumour cannot be surgically removed
• You have other serious health conditions that could interfere with the study
• You are pregnant or breastfeeding
• You have had another type of cancer in the past, unless it was successfully treated and has not returned
• You are currently participating in another clinical trial
• You have an allergy to any of the study medications
• You have an active infection requiring treatment
• You have a history of severe heart problems or autoimmune diseases (conditions where the immune system attacks the body)
• You have received a live vaccine within 30 days before starting the study

Focus and goal of the trial:

The study evaluates how effective the combination of chemotherapy and nivolumab is when given before surgery (neoadjuvant treatment) at reducing tumour size and achieving complete removal during surgery. After surgery, depending on the results, participants may receive additional treatment (adjuvant treatment) to eliminate any remaining cancer cells and prevent the cancer from returning. Throughout the study, researchers will closely monitor how patients respond to treatment, track any side effects, and measure how long patients live without the cancer returning over a 24-month period.

Investigational drugs:

The trial uses nivolumab, an immunotherapy medication that helps the body's immune system recognize and attack cancer cells more effectively. Nivolumab is a type of drug called a monoclonal antibody that works by blocking the PD-1 protein on immune cells, which activates the immune system to fight cancer. It is given as an intravenous infusion (through a vein) in combination with standard chemotherapy drugs. The chemotherapy works to kill or slow the growth of cancer cells, particularly before surgery to shrink the tumour and increase the chances of successful removal.