Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced but hasn't spread to other parts of the body, and can't be treated with surgery. Researchers are testing if adding newer drugs, pembrolizumab and olaparib, to standard chemotherapy and radiation therapy works better than current treatments. They want to see if this new combination can help people live longer and prevent the cancer from growing for a longer time. Participants will receive chemotherapy and radiation, followed by maintenance treatment with either pembrolizumab alone, or pembrolizumab with olaparib, and compare these to an existing treatment, durvalumab.
At a glance
What is this study about?
This study, called KEYLYNK-012, is looking for better ways to treat a specific type of lung cancer. It focuses on Non-Small Cell Lung Cancer (NSCLC) that is considered advanced (Stage III), meaning it has grown quite a bit but hasn't spread to distant parts of the body. Importantly, this study is for people whose cancer cannot be completely removed by surgery. Current standard treatment often involves chemotherapy (drugs that kill cancer cells) and radiotherapy (high-energy rays to kill cancer cells), sometimes followed by another drug like durvalumab.
The researchers want to see if adding two newer drugs, pembrolizumab and olaparib, to this standard treatment can make a difference. Pembrolizumab helps your body's immune system fight cancer, while olaparib is a targeted drug that can damage cancer cells. The study aims to find out if these additions can help people live longer and keep their cancer from growing for a longer time compared to the current approaches.
Participants will receive initial treatment with chemotherapy and radiotherapy. After this, they will be randomly assigned to one of three groups: one group will receive pembrolizumab alone, another will receive pembrolizumab together with olaparib (or a dummy pill that looks like olaparib), and a third group will receive durvalumab, which is an existing treatment. By comparing these groups, doctors hope to learn if the new combinations are more effective and safe.
Key takeaways
- This study is for advanced, non-operable Non-Small Cell Lung Cancer (Stage III).
- It tests if new drugs (pembrolizumab, olaparib) improve survival when added to standard treatment.
- Participants receive initial chemotherapy and radiation, then a maintenance drug.
- The study compares new drug combinations to an existing treatment (durvalumab).
- It aims to find better ways to keep cancer from growing and help people live longer.
Who may be eligible?
To join this study, you would need to have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC). Your doctors must have confirmed that your cancer is Stage IIIA, IIIB, or IIIC, meaning it's advanced but hasn't spread widely, and that it can't be fully removed with surgery.
It's important that you haven't received any previous treatment for this Stage III lung cancer, such as chemotherapy or radiation. You would also need to be generally well enough to take part, as assessed by your doctor, and have an opinion that you're likely to live for at least another six months. Your doctors will need to be able to measure your cancer on scans.
If you are a man, you must agree to use contraception to prevent pregnancy and not donate sperm during the study and for a certain time afterward. If you are a woman, you must not be pregnant or breastfeeding, and you must agree to use contraception during the study and for a certain period after your last dose of study medications.
- Do you have Non-Small Cell Lung Cancer (NSCLC)?
- Has your cancer been diagnosed as Stage IIIA, IIIB, or IIIC?
- Has your doctor said surgery isn't an option for your cancer?
- Have you NOT received any previous treatment for your Stage III lung cancer?
- Are you generally feeling well enough for treatment (ECOG 0 or 1)?
- Are you able to use reliable birth control if you are a man or a woman?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
Taking part in this study would involve several steps. First, you'll undergo standard treatment with chemotherapy (drugs given to fight cancer) and radiotherapy (radiation to the chest). After this initial phase, you'll be assigned to one of three treatment groups. Two groups will receive pembrolizumab, either alone or with olaparib (or a placebo, a dummy pill that looks like olaparib). The third group will receive durvalumab.
You'll have regular hospital visits for medical checks, blood tests, and scans to monitor your health and how the treatment is working. You'll take the study medications as prescribed. The total length of your participation will depend on how you respond to the treatment and the specific study protocol, but it will involve ongoing follow-up for a period after your main treatment ends to track your health and cancer status.
Potential risks and benefits
Locations (205)
- University of South Alabama, Mitchell Cancer Institute ( Site 0003)Mobile, United States
- St. Bernards Medical Center ( Site 0089)Jonesboro, United States
- St Joseph Heritage Healthcare-Oncology ( Site 0088)Fullerton, United States
- Long Beach Memorial Medical Center ( Site 0006)Long Beach, United States
- UCLA Hematology/Oncology - Santa Monica ( Site 0013)Los Angeles, United States
- St. Joseph Heritage Healthcare Local Lab ( Site 0011)Santa Rosa, United States
- Torrance Memorial Physician Network / Cancer Center ( Site 0093)Torrance, United States
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)Hollywood, United States
- Miami VA Healthcare System ( Site 0024)Miami, United States
- Mid Florida Hematology and Oncology Center ( Site 0022)Orange City, United States
- Orlando Health, UF Health Cancer Center Inc ( Site 0092)Orlando, United States
- Fort Wayne Medical Oncology and Hematology ( Site 0094)Fort Wayne, United States
+193 more sites — see the official record for the full list.
Common questions
What is Non-Small Cell Lung Cancer (NSCLC)?
It's the most common type of lung cancer, and this study focuses on advanced cases that haven't spread widely and can't be removed by surgery.
What are pembrolizumab and olaparib?
Pembrolizumab helps your body's immune system fight cancer. Olaparib is a targeted drug that helps damage cancer cells. They are being tested to see if they improve current treatments.
Will I know which treatment I'm getting?
For some parts of the study, you won't know if you're getting olaparib or a dummy pill (placebo). This helps researchers fairly compare the effects of the drugs. The durvalumab group will know they are receiving durvalumab.
What is 'Phase 3' of a clinical trial?
Phase 3 means this is a large study comparing the new treatments against existing ones to see if they are better and safe for wider use.
What does 'chemotherapy and radiotherapy' involve?
Chemotherapy uses drugs to kill cancer cells, and radiotherapy uses high-energy rays to target and destroy them. These are standard cancer treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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