This phase 1 trial aims to determine the dosage of the anti-cancer drug pembrolizumab (Keytruda, or MK-3475) and whether it is effective at treating small-cell lung cancer (SCLC) when combined with both chemotherapy and radiation therapy. The main outcome of the trial will be the maximum tolerated dose (MTD - the highest dose of a drug that does not cause harmful side effects) of pembrolizumab and progression free survival (PFS - time from beginning of trial until disease progression).
The details
PD-1 is a receptor in the body that reduces the effectiveness of the immune system. PD-1 inhibitors, including pembrolizumab, can block the PD-1 receptor and activate the immune system to attack tumors. Usually, SCLC is treated with a combination of two chemotherapy agents. In addition, chemotherapy combined with radiation therapy can be effective in SCLC.
This trial will investigate whether pembrolizumab is effective when combined with both chemotherapy and radiation therapy or chemotherapy alone. The trial will determine the optimal dose of pembrolizumab as well as its effectiveness in regards to disease progression.
Who are they looking for?
The trial is recruiting 80 participants with either limited or extensive SCLC. Participants must have adequate organ function and agree to use contraception during the course of the trial, and for 4 months after the trial. Women cannot be pregnant or breastfeeding.
Participants who have been treated with an investigational agent, chemotherapy or monoclonal antibody within 2 weeks prior to the trial will be excluded. Participants who have or had an autoimmune disease requiring treatment will be excluded. In addition, participants cannot have had any immunodeficiency or systemic steroid therapy within 7 days prior to the trial or have had a live vaccine within 30 days prior to the trial. Participants must have recovered from any previous drug related side effects and must not have any other known progressing cancer. Participants with substance abuse problems or psychiatric disorders will be excluded. Participants must not have received prior treatment with any other PD-1 inhibitor.
How will it work
The trial will have two parts; A and B.
Part A will include participants with limited SCLC. These participants will be treated with a combination of pemrolizumab, double agent chemotherapy and radiation. All of the anti-cancer drugs are administered by IV (through a vein).
Part B will include participants with extensive SCLC, who will be split into two groups. One group will be treated with a combination of pemrolizumab, double agent chemotherapy and radiation, while the other group will be treated with pemrolizumab and double agent chemotherapy only.
Participants will have follow up physical exams and blood tests every 3 weeks, and a final follow up CT or PET scan 12 weeks after finishing the treatment.
