All studies
Active not recruitingPHASE3INTERVENTIONAL

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

The POSEIDON study is looking at new ways to treat advanced non-small cell lung cancer (NSCLC) that has spread. It involves three groups of patients. One group receives standard chemotherapy, which is the usual treatment. Another group gets chemotherapy plus a new drug called durvalumab. The third group receives chemotherapy along with both durvalumab and another drug called tremelimumab. The aim is to see if adding these new drugs, which are a type of immunotherapy, can be more effective than chemotherapy alone in controlling the cancer and improving patients' lives. This study is for patients whose cancer doesn't have certain genetic changes (EGFR or ALK mutations).

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
1,186
Start
01 Jun 2017
Estimated completion
15 Nov 2027

Results

Results from this study

Posted April 2022

Results have been published for this study.

Primary outcome
Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
PFS (per RECIST version 1.1 \[RECIST 1.1\] using Blinded Independent Central Review \[BICR\] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity).
Full results on the registry

What is this study about?

This study, named POSEIDON, is designed to find better treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (this is called metastatic cancer). Researchers are investigating if combining existing chemotherapy with new drugs can improve outcomes for patients.

The study involves three different treatment paths. In one path, patients will receive the standard chemotherapy that doctors currently use for this type of cancer. In the second path, patients will receive this standard chemotherapy plus a drug called durvalumab. Durvalumab is a type of immunotherapy, which means it helps your body's own immune system fight the cancer. In the third path, patients will receive the standard chemotherapy, durvalumab, and an additional drug called tremelimumab, which also works with the immune system.

The main goal of the POSEIDON study is to find out if adding these new immune-boosting drugs makes the treatment more effective than chemotherapy alone. This includes whether it can slow down or shrink the cancer, and if it helps people live longer and feel better. By carefully comparing these different treatments, doctors hope to discover if these new drug combinations offer a significant improvement for patients with this specific kind of lung cancer.

Key takeaways

  • Tests new drug combinations for advanced non-small cell lung cancer.
  • Compares standard chemotherapy with two new immunotherapy drugs.
  • Specifically for patients whose cancer doesn't have certain genetic changes (EGFR/ALK).
  • Participation involves regular treatments, check-ups, and scans.
  • Aims to find out if the new drugs are more effective and improve patient outcomes.
  • You'll be part of one of three groups, chosen by chance.

Who may be eligible?

To be considered for the POSEIDON study, patients generally need to be 18 years or older and have non-small cell lung cancer that has spread. An important requirement is that your cancer cells must not have certain specific gene changes, known as EGFR mutations or ALK fusions, as the study is focusing on cancers without these particular features. You also shouldn't have had any chemotherapy or other standard drug treatments for your advanced lung cancer yet.

There are also some health requirements. Your general health and ability to carry out daily activities, often described as your 'performance status,' should be good (rated 0 or 1). You also shouldn't have previously received certain types of immune-boosting treatments, except for some cancer vaccines.

However, some conditions would mean you can't join the study. For example, if you have certain types of autoimmune diseases (where your immune system attacks your own body), or if you have specific active infections like tuberculosis, hepatitis B, hepatitis C, or HIV. Having brain spots (metastases) or spinal cord compression would also exclude you, unless they are stable and you are no longer taking steroid medication for them.

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. Do you have non-small cell lung cancer that has spread?
  3. Has your doctor confirmed your cancer doesn't have specific EGFR or ALK gene changes?
  4. Have you not had chemotherapy or other drug treatments for your advanced lung cancer yet?
  5. Is your general health good enough to carry out most daily activities?
  6. Do you not have certain immune system conditions or active infections like HIV or hepatitis?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the POSEIDON study, you would be randomly assigned to one of three treatment groups, much like drawing straws, so neither you nor your doctor chooses which group you're in. All groups involve receiving treatment in cycles. You'll have regular hospital visits for your treatments and check-ups. During these visits, the medical team will monitor your health closely, perform physical exams, and take blood tests.

You'll also have scans, like CT scans, at regular intervals to see how your cancer is responding to the treatment. These scans will continue until the treatment is no longer working as well as hoped. Even after you stop the main study treatment, the research team will continue to follow up with you to check on your overall health and well-being for the duration of the study.

The total duration of your participation will vary. The treatment phase, including regular assessments, continues as long as the treatment is beneficial and you are tolerating it. After treatment, you will be followed for survival until the study ends, which could be several years.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments that are not yet widely available, and you would be closely monitored by a team of experts. However, there are also potential risks. The new treatments being tested might cause side effects, which could be unpleasant or, in rare cases, serious. Some treatments might not work as well as expected, or they might not work for you at all. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (175)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Phoenix, United States
  • Research Site
    Verified postcode
    Bakersfield, United States
  • Research Site
    Verified postcode
    Santa Monica, United States
  • Research Site
    Verified postcode
    Fort Myers, United States
  • Research Site
    Verified postcode
    Jacksonville, United States
  • Research Site
    Verified postcode
    St. Petersburg, United States
  • Research Site
    Verified postcode
    West Palm Beach, United States
  • Research Site
    Verified postcode
    Louisville, United States
  • Research Site
    Verified postcode
    Kansas City, United States
  • Research Site
    Verified postcode
    Canton, United States
  • Research Site
    Verified postcode
    Pittsburgh, United States
  • Research Site
    Verified postcode
    Chattanooga, United States

Common questions

What is Non-Small Cell Lung Cancer (NSCLC)?

It's the most common type of lung cancer. This study is for NSCLC that has spread.

What are durvalumab and tremelimumab?

They are types of immunotherapy, which means they help your own immune system fight the cancer.

What does 'randomized' mean in a study?

It means you'll be assigned to a treatment group by chance, like flipping a coin. Neither you nor your doctor can choose the group.

Why can't people with EGFR or ALK gene changes join?

This study is specifically looking at treatments for NSCLC without these particular changes, as those changes already have different targeted treatments.

What does 'Standard of Care (SoC) chemotherapy' mean?

It refers to the best regular chemotherapy treatment currently available for your type of cancer.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.