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Study identifier: NCT07566052 Synced from ClinicalTrials.gov · July 29, 2026
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A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation

Condition: Non-small Cell Lung Cancer (NSCLC)  ·  Sponsor: Astellas Pharma Global Development, Inc.

PhasePhase 3
Planned participants356
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells. If the cancer gets worse, the next main treatment is usually a medicine called docetaxel. This treatment doesn't stop most people's cancer from getting worse for very long. Other treatments are needed to improve outcomes in people with NSCLC. Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with NSCLC have a faulty KRAS gene in their tumor. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. Setidegrasib (ASP3082) is thought to remove some of the abnormal proteins made from the faulty KRAS gene. Before setidegrasib can become available as a treatment, studies need to be done. This study is for people with NSCLC with a faulty KRAS gene in their tumor. In this study, some people will be given setidegrasib and some people will be given docetaxel. The main aims are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel, and if they live for longer. Other aims are to check tumor response, symptoms, how the body processes setidegrasib,…

This description comes directly from the study's public registry record.

Talk to the study team

Astellas Pharma Global Development, Inc.  ·  800-888-7704  ·  astellas.registration@astellas.com

Always discuss trial participation with your own doctor first.

Locations (5)

Oncura Health d.b.a.Los Angeles Cancer NetworkGlendale, California, United StatesRecruiting
Astera Cancer CareEdison, New Jersey, United StatesRecruiting
Virginia Cancer SpecialistsArlington, Virginia, United StatesRecruiting
Hokkaido University HospitalSapporo, Hokkaido, JapanRecruiting
Miyagi Cancer CenterNatori-shi, Miyagi, JapanRecruiting

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Source record: clinicaltrials.gov/study/NCT07566052