About this trial
In this study it looks at how well the study drug, STK-012 works when it is given with other approved lung cancer treatments. The combination of pembrolizumab, pemetrexed, and carboplatin is a standard treatment for your lung cancer.
STK-012 is a modified (changed in laboratory) form of a cytokine (protein) called interleukin-2 (IL-2). This protein is normally made by your immune system (the body’s natural defences) in the body and can help your body to recognise and destroy cancer cells. It’s hoped that STK-012 may help to activate your immune system to attack cancer cells.
The other Standard Treatments given as part of this trial are:
Pembrolizumab (also know as KEYTRUDA®)is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Pembrolizumab has been designed to attach to and block an antigen called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells. This increases the ability of the immune system to kill tumour cells.
Pemetrexed (also known as ALIMTA®) and carboplatin (also known as PARAPLATIN®) are combined chemotherapy treatments. Pemetrexed is a type of drug known as an anti-metabolite. It stops cancer cells making and repairing DNA so they can’t grow and multiply. DNA is the genetic code that is at the centre of all animal cells. It controlls everything the cell does.Carboplatin is a group of drugs know as alkylating agents, which is a type of chemotherapy. Carboplatin works by sticking to one of the cancer cell’s DNA strands. The cancer cell cannot then grow and divide.
Patients who are eligible to participate on this study will be assigned by chance (one chance in three) to one of three treatment groups via a process called randomization. The treatment groups are:
1. Pembrolizumab, pemetrexed, and carboplatin plus STK-012 (2.25mg)
2. Pembrolizumab, pemetrexed, and carboplatin plus STK-012 (1.5mg)
3. Pembrolizumab, pemetrexed, and carboplatin alone
The 2 doses of STK-012 being tested were determined to be safe dose levels in the first part of this study, this is part 2 (or Phase 2). This study will look at the responses patient’s cancer has to the different treatment combinations.
Patients will receieve the treatment for up to 2 years if your doctor believes you are benefiting from the treatment. The Treatments will be given through a vein in your arm (intraveneously) evey 21 days (a cycle) except Carboplatin which will only be given for the first 4 cycles, as is standard. When treatment is finished you will enter into a follow up period of about 4 years.
About 105 patients will take part in this study.
Patient Profile
The patients will have non-squamous (NSQ), non-small cell lung cancer (NSCLC) who have had no previous systemic therapy for advanced or metastatic NSQ NSCLC
Where’s this trial being run?
Beaumont Hospital, St James’s Hospital, University Hospital Galway, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | STK-012 |
|---|---|
| Number: | 26-27 |
| Full Title: | Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers (SYNERGY-101) |
| Principal Investigator: | TBC |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Synthekine |
| Recruitment Started: |
Global: Ireland: |
| Global Recruitment Target: | 105 |
|---|---|
| Ireland Recruitment Target: | 15 |