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NCT07566052 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 356
- Enrollment target
NCT07566052 is a Phase 3 study that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 356 participants.
The verdict
NCT07566052, a Phase 3 study, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 356 participants
- Enrollment target
Study Summary
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, and its safety, compared with docetaxel. The main aims of study 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 people who are given setidegrasib live for longer compared to people who are given docetaxel. People in this study will be adults with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) with the G12D mutation in their KRAS gene. Locally advanced means the
Interventions
- DRUG Docetaxel
- DRUG Setidegrasib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 356 participants |
| Start Date | 2026-04-28 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07566052
The ClinicalTrials.gov registry entry for NCT07566052 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 356 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT07566052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07566052 about?
NCT07566052 is a clinical study titled "A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation". 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 treatmen...
What is the current status of trial NCT07566052?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 356 participants. The study started on 2026-04-28. Estimated completion is 2030-06-30.
What interventions are being tested in trial NCT07566052?
The interventions under investigation include: Docetaxel (DRUG), Setidegrasib (DRUG).
Who is sponsoring clinical trial NCT07566052?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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