Actively Recruiting
A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Have Progressed After Platinum Chemotherapy and Checkpoint Inhibitor Therapy
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-08
356
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-small cell lung cancer (NSCLC) is the most common lung cancer type, often first treated with chemotherapy combined with targeted treatments. When the cancer worsens, docetaxel is commonly used but usually does not stop progression for long. Many people with NSCLC have a faulty KRAS gene, specifically a G12D mutation, which causes abnormal proteins that researchers aim to block with new treatments. This study compares two treatments for adults with advanced NSCLC having the KRAS G12D mutation. Participants will receive either setidegrasib, a drug thought to remove abnormal proteins from the faulty KRAS gene, or docetaxel. Setidegrasib is given by intravenous infusion on days 1, 8, and 15 of every 21-day cycle, while docetaxel is given by infusion on day 1 of every 21-day cycle. Treatment continues until cancer worsens, side effects are intolerable, other treatments begin, or the participant or doctor decides to stop. Some receiving docetaxel may switch to setidegrasib if their cancer progresses. Participants will have safety checks and tumor scans every 6 weeks for the first year, then every 9 weeks until cancer worsens. After progression, clinic staff will call every 12 weeks to monitor cancer status. Researchers will measure how long cancer stays controlled without worsening and overall survival, as well as tumor response, symptoms, quality of life, drug effects in the body, and safety. The study may last up to several years to gather this information.
CONDITIONS
Brief Title
A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed locally advanced (unresectable) or metastatic NSCLC with documented KRAS G12D mutation
- Positive KRAS G12D mutation result available prior to randomization from tumor tissue or plasma ctDNA
- Progressed or recurred after platinum-based chemotherapy combined with anti-PD-1/PD-L1 antibody
- No more than two prior systemic treatments for locally advanced or metastatic NSCLC
- Female participants must not be pregnant, not breastfeeding, and agree to contraceptive guidance if applicable
- ECOG performance status of 0 or 1 within 7 days before randomization
- Consent to provide baseline tumor tissue and plasma specimens during screening
You will not qualify if you...
- Known untreated or symptomatic central nervous system metastases
- Mixed small-cell lung cancer and NSCLC histology
- Leptomeningeal disease from current cancer
- Another active malignancy requiring treatment within past 2 years, except certain local cured cancers
- Active hepatitis B or C infection
- HIV infection without stable antiretroviral therapy and controlled viral load
- Peripheral neuropathy grade 2 or higher
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Recent therapeutic or palliative radiation within 14 days prior to randomization
- Known actionable mutations with approved targeted therapies available locally
- Prior treatment with docetaxel or KRAS-targeting agents
- Need for drugs that strongly affect CYP3A or CYP2D6 enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive Setidegrasib or Docetaxel via intravenous infusion in repeated 21-day cycles.
Up to 3 visits per 21-day cycle
Duration - Up to 4.2 years
Participants are monitored for overall survival and long-term safety after treatment ends.
Periodic visits over several years
Trial Site Locations
Total: 2 locations
1
Oncura Health d.b.a.Los Angeles Cancer Network
Glendale, California, United States, 91204
Actively Recruiting
2
Virginia Cancer Specialists
Arlington, Virginia, United States, 22201
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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