This phase 3 trial will investigate the effectiveness of pembrolizumab (Keytruda) in non-small cell lung cancer (NSCLC).
The main outcomes will be the rates of survival without any signs and symptoms of cancer and overall survival.
The details
NSCLC is usually treated with a combination of surgery to remove tumors and chemotherapy. Pembrolizumab is a new cancer drug. It is an immune-checkpoint inhibitor (ICIs). ICIs block the pathway that cancer cells use to evade the immune system. ICIs have been tested in advanced cancer.
This trial will investigate the effectiveness of pembrolizumab combined with chemotherapy before and after surgery in NSCLC. The main outcomes will be the rates of survival.
Who are they looking for?
This trial will recruit 786 patients with NSCLC. Patients with Stage IIB and IIIA NSCLC are eligible for the trial. Patients cannot have been treated prior to this study. Patients must have adequate organ function and have a sample of tumor tissue available for analysis. Patients must agree to use highly effective methods of contraception or abstain from sexual intercourse.
Patients cannot take part in the trial if they are pregnant or breastfeeding. Patients with allergies to pembrolizumab or chemotherapy drugs cannot take part in the trial. Patients with active infections or a history of HIV, hepatitis B or C cannot take part in the trial. Other exclusion criteria include autoimmune disease, previous ICI treatment, recent vaccination and additional cancers.
How will it work
Patients will be randomly assigned to pembrolizumab or placebo (inactive drug) treatment. All patients will undergo standard chemotherapy followed by surgery to remove the tumor. Participants will also receive 4 cycles of pembrolizumab or placebo before surgery. After surgery patients will receive 13 cycles of PEM or placebo. The treatment phase of the trial will last 20 weeks. Patient follow-up will also be performed up to 5 years after treatment.
