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Active not recruitingPHASE3INTERVENTIONAL

Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]

This study, called IMpower010, is looking at a new treatment called Atezolizumab for people with a type of lung cancer called non-small cell lung cancer (NSCLC). This is specifically for patients who have had surgery to remove their cancer and have also received chemotherapy. The study wants to find out if Atezolizumab can help stop the cancer from coming back (called disease-free survival) and if it helps people live longer (overall survival) compared to just getting regular supportive care. Participants will be randomly assigned to either receive Atezolizumab for about a year, or continue with standard supportive care after their chemotherapy. This is a large, international study to gather important information about this new treatment.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
1,280
Start
31 Oct 2015
Estimated completion
31 Aug 2027

What is this study about?

This study is called IMpower010, and it's looking into a new treatment called Atezolizumab for a common type of lung cancer. This particular study focuses on people who have been diagnosed with non-small cell lung cancer (NSCLC) that's caught at an earlier stage (specifically Stage IB to IIIA). For these patients, the usual treatment involves having surgery to remove the cancer, followed by chemotherapy. This study wants to see if adding Atezolizumab after this standard treatment can make a difference.

The main goal is to find out if Atezolizumab can help prevent the cancer from coming back after surgery and chemotherapy, and if it can help people live longer. Participants will be randomly put into one of two groups. One group will receive Atezolizumab for about 16 treatment cycles (which works out to about a year), while the other group will receive what's called 'best supportive care'. Best supportive care means getting the usual medical care to manage symptoms and improve your comfort, but without the additional Atezolizumab treatment.

Learning whether Atezolizumab is effective in this early stage of lung cancer could potentially offer a new treatment option for patients. The study will carefully monitor all participants for any side effects and will compare the health outcomes between the two groups. This helps doctors understand if Atezolizumab is a safe and beneficial addition to current treatments for this type of lung cancer.

Key takeaways

  • Compares Atezolizumab to standard supportive care after lung cancer surgery and chemotherapy.
  • Aims to see if Atezolizumab prevents cancer recurrence and improves survival.
  • For early to mid-stage non-small cell lung cancer (NSCLC) patients.
  • Participants are randomly assigned to one of two groups.
  • Involves regular clinic visits and monitoring throughout the study.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have a specific type of lung cancer called non-small cell lung cancer (NSCLC) that's been diagnosed at an earlier stage (IB to IIIA). You must have had your cancer completely removed by surgery between 4 and 12 weeks before joining, and you should have recovered well from the operation.

It's also important that your general health is good, meaning your body is working well enough to be part of the study, and that you are otherwise fit and active with an ECOG performance status of 0 or 1. If you've had a detailed look at the lymph nodes in your chest during or after surgery, that's also a key part of the requirements.

You also must be suitable to receive a type of chemotherapy that contains cisplatin, and importantly, women who could become pregnant need to make sure they are using effective birth control.

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 or older?
  2. Do you have non-small cell lung cancer, stage IB to IIIA?
  3. Have you had surgery to completely remove your lung cancer 4-12 weeks ago, and are you recovering well?
  4. Are you suitable to receive chemotherapy containing cisplatin?
  5. Is your general health good enough for a clinical trial?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll first complete up to four cycles of standard chemotherapy that includes cisplatin. After that, you'll be randomly assigned to one of two groups. One group will receive the study drug, Atezolizumab, given as an infusion, every three weeks for a total of 16 cycles (about one year). The other group will receive "best supportive care," which means you'll get regular medical care to manage your health and symptoms, but without the study drug.

Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how you're responding to treatment. The total duration of your participation in the treatment phase of the study will vary depending on your assigned group, but follow-up to track your health outcomes will continue for a longer period. More details about the exact number of visits, tests, and follow-up schedule would be provided by the study team.

Potential risks and benefits

Taking part in a new treatment study like this could offer potential benefits, such as receiving a new immunotherapy medicine that might help prevent your cancer from returning or improve your long-term health. However, there are also potential risks involved, including side effects from Atezolizumab, which can vary from person to person. The research team will carefully monitor your health throughout the study and provide care for any side effects. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (154)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Highlands Oncology Group
    Verified postcode
    Fayetteville, United States
  • California Cancer Associates for Research & Excellence, Inc.
    Verified postcode
    Encinitas, United States
  • Compassionate Cancer Care Medical Group, Inc
    Verified postcode
    Fountain Valley, United States
  • University of California Los Angeles
    Verified postcode
    Los Angeles, United States
  • Kaiser Permanente
    Verified postcode
    Vallejo, United States
  • Kaiser Permanente - Walnut Creek
    Verified postcode
    Walnut Creek, United States
  • Eastern Connecticut Hematology and Oncology Associates
    Verified postcode
    Norwich, United States
  • Lynn Cancer Institute - West
    Verified postcode
    Boca Raton, United States
  • University of Miami School of Medicine - Sylvester at Deerfield
    Verified postcode
    Deerfield Beach, United States
  • SCRI Florida Cancer Specialists North
    Verified postcode
    St. Petersburg, United States
  • Lewis Hall Singletary Oncology Center
    Verified postcode
    Thomasville, United States
  • University of Illinois at Chicago
    Verified postcode
    Chicago, United States

Common questions

What is Atezolizumab?

Atezolizumab is a type of immunotherapy drug that helps your immune system fight cancer.

What does 'best supportive care' mean?

It means you'll receive the usual medical care to manage your symptoms and well-being, but without the new study drug.

Why is it important for my cancer to be at certain stages?

This study is specifically designed to investigate the effectiveness of Atezolizumab in early-stage lung cancer after surgery and chemotherapy.

Will I know if I'm getting Atezolizumab or supportive care?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.

How long will I be involved in the study?

If you receive Atezolizumab, it will be for approximately one year. However, follow-up to track your health will continue for longer.

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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