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Active not recruitingPHASE3INTERVENTIONAL

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

This research study is investigating a new treatment approach for people with a specific type of advanced lung cancer. It focuses on non-small cell lung cancer that has a particular gene change called a KRAS mutation, and has started to grow again after initial treatment. The study is comparing a new drug, selumetinib, given alongside standard chemotherapy (docetaxel), to see if this combination is more effective and safe than chemotherapy with a dummy drug (placebo). Researchers will also look at how patients feel and experience this treatment. The goal is to find better ways to treat this challenging form of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
510
Start
25 Sep 2013
Estimated completion
31 Dec 2025

What is this study about?

This study is called SELECT-1, and it's looking into a new treatment for a type of lung cancer known as non-small cell lung cancer (NSCLC). Specifically, it's for patients whose cancer is considered advanced (Stage IIIb or IV), meaning it has spread beyond its original location. A key part of this study is that it's only for people whose cancer cells have a particular genetic change called a KRAS mutation. This mutation can make the cancer harder to treat with standard therapies.

The main idea is to see if adding a new drug called selumetinib to a standard chemotherapy drug, docetaxel, works better than giving docetaxel with a dummy drug (placebo). Researchers want to find out if this combination can shrink tumours more effectively, slow down cancer growth, and extend lives. They will also carefully monitor any side effects and how the treatment affects patients' daily lives and well-being.

This kind of study is really important because it could lead to new and more effective treatments for people living with KRAS-positive NSCLC. It's designed to give us clearer answers about whether this new drug combination is a good option for patients who need further treatment after their first cancer therapy hasn't fully worked or has stopped working.

Key takeaways

  • This study is for locally advanced or metastatic non-small cell lung cancer with a KRAS gene mutation.
  • It's for patients who need 'second-line' treatment after their first therapy.
  • It compares a new drug (selumetinib) plus chemotherapy to chemotherapy plus a dummy pill.
  • Participation involves regular hospital visits, treatments, tests, and questionnaires.
  • The study aims to find more effective and safer treatments for this specific type of lung cancer.
  • You can withdraw from the study at any time without affecting your future care.

Who may be eligible?

To join this study, you would need to be 18 years or older and have non-small cell lung cancer that is locally advanced or has spread (Stage IIIb or IV). A crucial requirement is that your cancer must have a specific genetic change called a 'KRAS mutation,' which will be checked by the study organisers. You would also need to have received one previous course of anti-cancer treatment for your advanced lung cancer, and your cancer must have started to grow again or come back after that first treatment.

There are also some reasons why you might not be able to join. For example, if your lung cancer has a mix of small cell and non-small cell types, or if you've already had more than one anti-cancer treatment for your advanced lung cancer. You also can't have started any new anti-cancer treatment within 30 days before the study begins, and you can't be getting other cancer treatments while on the study (other than steroids). If you've previously been treated with a specific type of drug called an MEK inhibitor or a docetaxel-containing chemotherapy, you wouldn't be eligible, though prior treatment with paclitaxel is allowed.

Quick self-check
  • Are you 18 years or older?
  • Do you have locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)?
  • Has your doctor confirmed your cancer has a KRAS genetic mutation?
  • Have you already had one anti-cancer treatment for your advanced lung cancer, and it's stopped working or your cancer has come back?
  • Have you avoided other anti-cancer treatments (besides steroids) for at least 30 days before starting the study?
  • Have you never been treated with an MEK inhibitor or docetaxel-containing chemotherapy before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it's a 'Phase 3' trial, which means it compares a new treatment to a standard one with a dummy pill (placebo). You would be randomly assigned to receive either selumetinib plus docetaxel, or a placebo plus docetaxel – like flipping a coin, so neither you nor your doctor chooses which group you're in. This is also a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving, to keep the results as fair as possible.

You would have regular hospital visits for your IV docetaxel treatment and to take either the selumetinib or placebo pills. During these visits, the study team would perform various checks, including blood tests, scans (like CT scans) to monitor your cancer, and physical exams. You would also be asked to complete questionnaires about how you are feeling and your quality of life. The treatment would continue as long as it's helping and you are tolerating it well. After the treatment phase, there will be follow-up appointments to monitor your health. The total duration of your participation would depend on how your treatment progresses and the follow-up schedule.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. You might benefit from receiving a new treatment that could be more effective than standard care for your specific type of cancer. However, there's no guarantee the new treatment will work for you, and it may have side effects that are not yet fully known, or that are more severe than standard treatments. The study team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care. This decision is entirely yours, and you would not need to explain why if you chose to leave the study.

Locations (197)

  • Research Site
    Aurora, United States
  • Research Site
    Pembroke Pines, United States
  • Research Site
    Atlanta, United States
  • Research Site
    Chicago, United States
  • Research Site
    Metairie, United States
  • Research Site
    Boston, United States
  • Research Site
    Boston, United States
  • Research Site
    Danvers, United States
  • Research Site
    New York, United States
  • Research Site
    New York, United States
  • Research Site
    Durham, United States
  • Research Site
    Hershey, United States

+185 more sites — see the official record for the full list.

Common questions

What is a 'KRAS mutation'?

It's a specific change in a gene within your cancer cells that can affect how the cancer grows and responds to treatment.

What does 'second line treatment' mean?

This means the treatment is given after your first anti-cancer treatment for advanced lung cancer has either stopped working or your cancer has returned.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study drug but contains no active medicine. It helps compare the new drug's effects accurately.

Can I still get other medicines for my cancer during the study?

Generally no, apart from steroid medicines. The study carefully controls other treatments to ensure accurate results.

What is the purpose of regular scans and blood tests?

These tests help the doctors monitor how your cancer is responding to the treatment and to check your general health and safety during the study.

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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