All studies
Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

This important study is looking at a new way to treat certain types of early-stage non-small cell lung cancer. It involves using a drug called pembrolizumab alongside standard chemotherapy, both before and after surgery. The aim is to find out if this combination can help people live longer without their cancer coming back, and improve their overall survival. Participants will either receive pembrolizumab with chemotherapy before surgery and then pembrolizumab after surgery, or they will receive a placebo (a dummy drug) with chemotherapy before surgery and then a placebo after surgery. This is a "Phase 3" study, meaning it's a large trial to see if the new treatment is better than the current standard. Researchers will be carefully monitoring participants to understand the treatment's safety and how well it works.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
797
Start
24 Apr 2018
Estimated completion
29 Jun 2026

Results

Results from this study

Posted September 2024

Results have been published for this study.

Primary outcome
Event Free Survival (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).
Full results on the registry

What is this study about?

This study is designed to explore a new treatment strategy for a type of lung cancer called non-small cell lung cancer (NSCLC) that can be removed by surgery. Specifically, it's for people with Stage II, Stage IIIA, and certain Stage IIIB cancers. Currently, surgery is often combined with chemotherapy to treat these cancers. This study is investigating whether adding a drug called pembrolizumab to this treatment plan can make it even more effective.

Pembrolizumab is an immunotherapy drug. Immunotherapy works by helping your body's own immune system find and fight cancer cells. In this study, some people will receive pembrolizumab alongside their chemotherapy *before* surgery (this is called "neoadjuvant therapy"), and then continue to receive pembrolizumab *after* surgery (this is called "adjuvant therapy"). Others will receive chemotherapy with a placebo (a dummy drug) before surgery, and then a placebo after surgery.

The main goals of this study are to see if this combination of pembrolizumab and chemotherapy can help people live longer without their cancer returning (this is called "event-free survival") and to improve their overall lifespan. Researchers will also be closely monitoring any side effects to understand how safe the treatment is. This is a "Phase 3" study, which means it's one of the final steps to determine if this new treatment approach is better than what's currently available for this type of lung cancer.

Key takeaways

  • This study is for certain early-stage non-small cell lung cancer that can be operated on.
  • It tests a new combination of immunotherapy (pembrolizumab) and chemotherapy before and after surgery.
  • The main goals are to see if this treatment helps people live longer and prevents cancer from returning.
  • You would receive either the new combination or standard chemotherapy with a dummy drug (placebo).
  • Participation involves regular hospital visits, tests, and follow-up for several years.
  • This is a 'Phase 3' study, meaning it's a large trial aiming to prove a new treatment works better.

Who may be eligible?

To join this study, you would need to have non-small cell lung cancer that can be removed by surgery, specifically stages II, IIIA, or a certain type of IIIB cancer. It's important that your cancer hasn't been treated before. The medical team will also need a sample of your tumour tissue to check specific markers. You should also be generally well and able to carry out most normal daily activities, as assessed by your doctor.

There are some reasons why you might not be able to join. For example, if your lung cancer is in a very specific location, or if it's a rare type of lung cancer. You also wouldn't be able to join if you have a history of serious lung inflammation that needed strong medication like steroids, or certain serious infections. If you've had an organ transplant or have an active autoimmune disease requiring ongoing treatment, you also wouldn't be able to participate. You also can't have a known severe allergy to pembrolizumab or any of the chemotherapy drugs used in the study.

If you are a woman who could become pregnant, or a man, you must agree to use effective birth control throughout the study and for some time after the last treatment. Women also cannot be pregnant or breastfeeding. These measures are in place because the study drugs could potentially harm an unborn baby.

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. Do you have non-small cell lung cancer (NSCLC) that your doctor says can be removed by surgery?
  2. Has your NSCLC not been treated with drugs before?
  3. Are you generally well enough to go about your daily activities?
  4. Do you not have a history of serious lung inflammation or certain other serious health issues?
  5. Are you able to provide a sample of your tumour tissue?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first receive treatment before your surgery. This will involve a combination of either pembrolizumab or a placebo, given alongside standard chemotherapy. After that phase, you will have your surgery. Following surgery, you will continue to receive either pembrolizumab or a placebo. The chemotherapy drugs used are cisplatin, gemcitabine, or pemetrexed – your doctor will discuss which is right for you.

Throughout the study, you will have regular visits to the hospital for doctors' appointments, blood tests, scans, and to receive your medication. These visits will help the medical team monitor your health, check how well the treatment is working, and look for any side effects. After your treatment phases are complete, you will have long-term follow-up appointments to track your health and how your cancer is doing over time. The total duration of the treatment and follow-up will be explained by the study team, but it's important to remember that such studies often involve several years of monitoring.

Potential risks and benefits

Participating in this study might offer potential benefits, such as possibly improving your chances of living longer without your cancer returning, and potentially improving your overall survival, compared to standard treatment. However, there are no guarantees, and it's also possible that the treatment won't work for you. As with any medical treatment, there are potential risks and side effects associated with pembrolizumab and chemotherapy. These can include allergic reactions or other side effects specific to these medications, which your doctor will discuss in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (227)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner MD Anderson Cancer Center ( Site 0028)
    Verified postcode
    Gilbert, United States
  • Western Regional Medical Center, Inc. ( Site 0050)
    Verified postcode
    Goodyear, United States
  • University of Arizona Cancer Center - Dignity Health ( Site 0062)
    Verified postcode
    Phoenix, United States
  • University of Arizona Cancer Center ( Site 0012)
    Verified postcode
    Tucson, United States
  • Pacific Cancer Medical Center, Inc. ( Site 0004)
    Verified postcode
    Anaheim, United States
  • Providence Saint Joseph Medical Center ( Site 0061)
    Verified postcode
    Burbank, United States
  • Pacific Cancer Care ( Site 0035)
    Verified postcode
    Monterey, United States
  • John Wayne Cancer Institute ( Site 0049)
    Verified postcode
    Santa Monica, United States
  • St Joseph Heritage Healthcare ( Site 0040)
    Verified postcode
    Santa Rosa, United States
  • Stanford University, Stanford Cancer Center ( Site 0046)
    Verified postcode
    Stanford, United States
  • Hartford Hospital ( Site 0069)
    Verified postcode
    Hartford, United States
  • Helen F. Graham Cancer Center & Research Institute ( Site 0015)
    Verified postcode
    Newark, United States

Common questions

What is pembrolizumab and how does it work?

Pembrolizumab is a type of immunotherapy. It helps your body's immune system to recognise and fight cancer cells more effectively.

What does 'neoadjuvant' and 'adjuvant' mean?

'Neoadjuvant' means treatment given before surgery to shrink the tumour. 'Adjuvant' means treatment given after surgery to help prevent the cancer from coming back.

Will I know if I'm getting pembrolizumab or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving pembrolizumab or the placebo. This helps ensure the results are fair and unbiased.

What stage of lung cancer is this study for?

This study is for people with resectable (meaning it can be removed by surgery) Stage II, Stage IIIA, and a specific type of Stage IIIB non-small cell lung cancer.

How long will I be in the study?

The treatment part of the study involves several months, followed by long-term follow-up visits, which can continue for several years to monitor your health.

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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