Active not recruitingPHASE3INTERVENTIONAL

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

This is a research study called CodeBreak 200, looking into a new medication named AMG 510, also known as Sotorasib. We're comparing it to a common chemotherapy drug called Docetaxel. The study is for adults with a type of lung cancer known as non-small cell lung cancer (NSCLC) that has become advanced or spread to other parts of the body. Importantly, participants must have a specific genetic change in their cancer, called a KRAS G12C mutation, which will have been identified by a previous test. This study aims to see if the new medicine is a better option for these patients than the current treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

345

Start

04 Jun 2020

Estimated completion

24 Jun 2026

KRAS p, G12c Mutated /Advanced Metastatic NSCLC

What is this study about?

This study is an important research project called CodeBreak 200. It's open to people who have a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced, and has a specific genetic change known as KRAS G12C. This genetic change is found in the cancer cells and can affect how the cancer grows. Doctors involved in this study have already tried other treatments for participants' cancer, but are now looking for more effective options.

The main goal of this study is to compare a new medicine, AMG 510 (which is also being called Sotorasib), with a standard chemotherapy drug named Docetaxel. Docetaxel is a commonly used treatment for this type of lung cancer. By comparing these two treatments, researchers hope to understand if AMG 510 could be a better or safer choice for people with this particular cancer type.

This is a 'Phase 3' study, which means it's one of the final steps in testing a new medicine. Before this, the new medicine would have been tested in smaller groups of people to make sure it was generally safe. Now, with a larger group, researchers can get a much clearer picture of how well it works and any side effects it might have compared to an existing treatment. This research is crucial for developing better treatments for this specific type of lung cancer.

Key takeaways

This study compares a new drug (AMG 510/Sotorasib) with a standard chemotherapy (Docetaxel).
It's for people with advanced non-small cell lung cancer.
Participants must have a specific KRAS G12C gene change in their cancer.
You will receive either the new drug or standard chemotherapy by chance.
Participation involves regular clinic visits, tests, and closely monitored treatment.
It aims to find out if the new drug is a more effective option for this lung cancer type.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. You must have non-small cell lung cancer (NSCLC) that has spread or is advanced, and has already been treated with other medicines. A very important requirement is that your cancer must have a specific genetic change called a KRAS G12C mutation, which will be confirmed by special tests.

There are also some reasons why you might not be able to join. For example, if you have active cancer that has spread to your brain, or if you've had a heart attack in the last six months, you wouldn't be able to participate. Also, if you have problems with your stomach or gut that stop you from taking medicines by mouth, this study might not be right for you. Your study doctor will check all these details carefully with you.

Quick self-check

Are you 18 years old or older?
Do you have advanced or spread non-small cell lung cancer that's already been treated?
Has your cancer been tested and confirmed to have a KRAS G12C genetic change?
Do you currently have active cancer that has spread to your brain (if yes, you might not be eligible)?
Have you had a heart attack in the last 6 months (if yes, you might not be eligible)?
Can you take medicines by mouth without serious stomach or gut problems?

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

What does participation involve?

If you decide to participate in this study, you will be given either the new medicine, AMG 510, or the standard chemotherapy, Docetaxel. You won't get to choose which one you receive; this will be decided by chance, like flipping a coin. You will have regular visits to the clinic for medical checks, scans, and blood tests to see how you are doing and how the medicine is affecting you. These visits will help the study team monitor your health and the progress of your cancer. The exact number and timing of visits will be explained to you by the study team, along with how long you will be taking the medication and how long the follow-up period will be. The total duration of your participation will vary, but generally involves regular treatment cycles and follow-up appointments.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. The new medicine, AMG 510, might work better for your cancer than current treatments. However, like all medicines, both AMG 510 and Docetaxel have potential risks and side effects. These could range from mild to serious, and the study team will fully explain what to expect. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (274)

Pacific Cancer Medical Center Inc
Anaheim, United States
City of Hope National Medical Center
Duarte, United States
Pacific Shores Medical Group Long Beach
Long Beach, United States
University of California Los Angeles
Los Angeles, United States
University of California Los Angeles
Los Angeles, United States
University of California at Davis Medical Center
Sacramento, United States
Ridley Tree Cancer Center
Santa Barbara, United States
University of California San Francisco Mission Hall
Stanford, United States
Harbor University of California Los Angeles Medical Center
Torrance, United States
Rocky Mountain Cancer Centers
Denver, United States
Danbury Hospital
Norwalk, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, United States

+262 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer (NSCLC)?

NSCLC is the most common type of lung cancer. This study focuses on a specific kind that has spread or is advanced.

What is a KRAS G12C mutation?

It's a specific genetic change in the cancer cells that can make the cancer grow. This study is for people whose cancer has this particular change.

What does 'Phase 3' mean for a study?

Phase 3 means the medicine has already been tested for safety in smaller groups and is now being compared to existing treatments in a larger group of patients to see if it's better.

Will I know which medicine I'm getting?

No, you won't get to choose. You'll be assigned either the new medicine or the standard chemotherapy by chance, like drawing lots.

What if I experience side effects?

The study team will closely monitor you for any side effects and provide care and advice. You should always tell them about any new or worsening symptoms.