Pembrolizumab After Lung SBRT for Medically Inoperable Early Stage Non-small Cell Lung Cancer
Status:
Withdrawn
Trial end date:
2020-03-21
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see whether patients who have early stage NSCLC bigger than a
certain size might benefit from receiving additional medicinal drug to treat their cancer
after the SBRT Surgeons and radiation doctors have understood for some time that the chances
of cancer showing up in areas outside the chest are higher for patients with tumors bigger
than 3 cm, (about 1 ΒΌ inches). However, it is not routine to offer chemotherapy or drug
treatments after radiation or surgery for lung cancer for patients with early stage lung
cancer. This is because giving extra treatment in the form of chemotherapy has not shown to
help patients live longer. There has been reluctance to offer additional treatments,
especially chemotherapy, to patients with lung cancer who could not have surgery because of
their medical issues. Even if these patients were felt to be at a higher risk of their cancer
coming back, there is hesitation because the treatments can be difficult to tolerate in frail
patients.
Recently, there have been very important advances in the kinds of drug therapy that are used
for lung cancer patients. These kinds of drugs are called immunotherapy since they work with
the body's immune system to fight the cancer. These drugs have been shown to make patients
with advanced, incurable lung cancer, live longer and also to be very safe with very limited
side effects. Because of these favorable characteristics, cancer specialists are interested
in using these drugs for patients with curable cancer and for patients who may be too fragile
for traditional chemotherapy. In this way, patients who get SBRT are already known to be
fragile so cancer doctors are interested in now studying this kind of drug in SBRT patients
to see if it can make patients with large tumors do better. The idea of the study then is
that the patient would receive their standard SBRT and if their tumor is of a certain size
that makes the risk of the cancer showing up outside the chest higher than routine, they
would be considered for getting the immunotherapy drug.
Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by
the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of
head and neck cancer. However, it has not been approved for use in other cancers such as
newly diagnosed early stage NSCLC. It is FDA approved for advanced NSCLC, that is people who
have already had some chemotherapy and their disease has worsened. Pembrolizumab is a
monoclonal antibody that binds to the surface of some cells of the immune system and
activates them against cancer cells. It is not chemotherapy.