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Active not recruitingPHASE3INTERVENTIONAL

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

This research study is for people recently diagnosed with Limited-Stage Small Cell Lung Cancer (LS-SCLC). This is a type of lung cancer that hasn't spread beyond the chest. The study aims to find out if new treatments, pembrolizumab and olaparib, can improve outcomes when given alongside standard chemotherapy and radiation. Currently, some people with LS-SCLC have standard chemotherapy and radiation. This study wants to see if adding one or both of these new drugs helps people live longer compared to getting only the standard treatment. The goal is to discover better ways to treat this specific type of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
672
Start
08 Dec 2020
Estimated completion
28 Oct 2027

What is this study about?

This study is about finding better ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC). This is a type of lung cancer that is found only in the lung and nearby areas, and has not yet spread to other parts of the body. Currently, people with this type of cancer often receive a combination of chemotherapy and radiation therapy, which is called chemoradiation therapy (CRT).

Researchers are investigating two new drugs called pembrolizumab and olaparib. Pembrolizumab is a type of immunotherapy that helps your body's own immune system fight cancer. Olaparib helps to stop cancer cells from repairing themselves. The main aim of this study is to see if adding these new drugs to the standard chemoradiation treatment can help people with LS-SCLC live longer than with standard treatment alone.

The study will compare different groups: some participants will receive the standard treatment plus pembrolizumab, some will receive the standard treatment plus both pembrolizumab and olaparib, and others will receive only the standard treatment. By comparing these groups, the researchers hope to understand if these new drug combinations are more effective.

Key takeaways

  • This study is for newly diagnosed Limited-Stage Small Cell Lung Cancer (LS-SCLC).
  • It tests if adding pembrolizumab and olaparib to standard treatment helps people live longer.
  • Participation involves receiving standard treatments, potentially new drugs, and regular check-ups.
  • You must not have had previous treatment for your LS-SCLC.
  • You will be closely monitored for effects of the treatment.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or over who have been newly diagnosed with Limited-Stage Small Cell Lung Cancer. This means your cancer has been confirmed by a doctor and is only in your lung or close by, and has not spread to other parts of your body. You should not have had any previous treatment for this lung cancer, such as chemotherapy or radiation, before joining the study.

To be considered, you'll need to be generally well enough to take part, as measured by a doctor's assessment (your 'performance score'). You should also have healthy organ function and be expected to live for at least six months. Your doctors will also need to be confident that you can safely receive radiation treatment.

You won't be able to join if you have a mixed type of lung cancer (small cell and non-small cell at the same time), if your cancer has already spread, or if you need surgery for your cancer during the study. There are also specific rules about not being pregnant or breastfeeding, and using contraception if needed.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been newly diagnosed with Limited-Stage Small Cell Lung Cancer that hasn't spread?
  3. Have you NOT had any previous treatment for this lung cancer?
  4. Are you generally well and fit enough for treatment, as assessed by your doctor?
  5. Are you not pregnant or breastfeeding, and willing to use contraception if needed?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either standard chemoradiation therapy alone, or standard therapy combined with one or both of the new study drugs (pembrolizumab and olaparib). The drugs will be given in specific doses and ways, for example, olaparib is given twice a day. You will have regular visits to the clinic for treatments, check-ups, and tests like PET/CT scans and MRI scans to monitor your health and how the treatment is working.

Researchers will also collect samples, such as a tumour tissue sample, before treatment begins. You may also receive a specific type of radiation to the brain, called Prophylactic Cranial Irradiation (PCI), if your doctor recommends it. The total length of your participation will depend on the treatment plan and follow-up required for your group, but it will involve ongoing assessments and potentially taking study drugs for a set period, followed by long-term monitoring.

Potential risks and benefits

Taking part in a clinical trial like this could offer the potential benefit of receiving new treatments that are not yet widely available, which might be more effective than standard care for your type of cancer. However, there are also potential risks, as the new drugs may cause side effects that are not yet fully known, or they may not work for everyone. Your study doctors will carefully explain all known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (187)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Ironwood Cancer & Research Centers ( Site 0007)
    Verified postcode
    Chandler, United States
  • Loma Linda University Cancer Center ( Site 0011)
    Verified postcode
    Loma Linda, United States
  • Georgetown University ( Site 0017)
    Verified postcode
    Washington D.C., United States
  • Moffitt Cancer Center ( Site 0137)
    Verified postcode
    Tampa, United States
  • University of Chicago Medical Center ( Site 0136)
    Verified postcode
    Chicago, United States
  • Fort Wayne Medical Oncology and Hematology ( Site 0034)
    Verified postcode
    Fort Wayne, United States
  • University of Kentucky Chandler Medical Center ( Site 0138)
    Verified postcode
    Lexington, United States
  • Overton Brooks VAMC ( Site 0041)
    Verified postcode
    Shreveport, United States
  • Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
    Verified postcode
    Baltimore, United States
  • VA Ann Arbor Healthcare System ( Site 0050)
    Verified postcode
    Ann Arbor, United States
  • St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
    Verified postcode
    Billings, United States
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
    Verified postcode
    Omaha, United States

Common questions

What is Small Cell Lung Cancer?

It's a type of lung cancer that tends to grow and spread quickly. Limited-Stage means it's still contained to the lung and nearby areas.

What are pembrolizumab and olaparib?

Pembrolizumab is a drug that helps your immune system fight cancer. Olaparib is a drug that interferes with cancer cells' ability to repair themselves.

What is 'standard' treatment?

In this study, 'standard' refers to chemotherapy combined with radiation treatment (chemoradiation therapy), which is a common way to treat this cancer.

Will I know which treatment I'm getting?

Because this is a 'blinded' study, neither you nor your study doctor will know if you are receiving the new drugs or a placebo (inactive substance) alongside your standard treatment. This helps ensure the study results are fair.

How long will the study last for me?

The length of your participation will depend on your assigned treatment group and how you respond, including follow-up visits after your main treatment ends.

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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