Setidegrasib vs Docetaxel for Non-small Cell Lung Cancer

A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer (NSCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
356 (estimated)
Sponsor
Astellas Pharma Global Development, Inc. · Industry
Who this trial is looking for

This trial is looking for people with non-small cell lung cancer and a specific KRAS G12D gene mutation. Participants will receive either setidegrasib or docetaxel to see which one helps their cancer for a longer time.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with non-small cell lung cancer.
  • I have a KRAS G12D mutation in my tumor.
  • I have had cancer that got worse after chemotherapy.
  • I am a woman who is not pregnant or breastfeeding.
  • I have provided a tumor tissue sample for testing.
  • I have an ECOG performance status of 0 or 1.

You may not be able to join if

  • I have untreated brain metastases.
  • I have mixed small-cell lung cancer and non-small cell lung cancer.
  • I have leptomeningeal disease.
  • I have another active cancer within the last 2 years.
  • I have a known hepatitis B or C infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status, based on local or central testing. * The participant's po…
Contacts

Astellas Pharma Global Development, Inc.

800-888-7704

astellas.registration@astellas.com

CONTACT