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Study of setidegrasib (ASP3082) and docetaxel in patients with KRAS G12D‑mutated advanced/metastatic NSCLC after platinum chemo and checkpoint inhibitor

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Non-small Cell Lung Cancer with KRAS G12D mutation is a type of lung cancer that has spread or cannot be removed with surgery. Patients in this study have already received chemotherapy that contains platinum and a type of immune therapy called checkpoint inhibitor. The trial compares two medicines given through an IV drip: the experimental drug setidegrasib (code name ASP3082) and the standard chemotherapy drug docetaxel. Both are provided as a concentrate mixed with fluid and infused into a vein.

The purpose of the study is to compare how long patients live without their cancer getting worse and overall survival between the two treatments. Participants are randomly assigned to receive one of the two medicines, receive the infusion every few weeks, and have regular check‑ups that may include scans and questionnaires about symptoms and quality of life. The study follows patients until the cancer progresses, side effects become too severe, or the patient chooses to stop, and it records the time until death from any cause. Terms such as KRAS G12D refer to a specific genetic change in the cancer cells, while Non-small Cell Lung Cancer is the common name for this type of lung cancer; IV infusion means the medicine is delivered through a needle placed in a vein. Progression‑free survival means the period during which the disease does not get worse, and overall survival means the total time a person lives after starting the study.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    After agreeing to join the study, you will be assigned by the study staff to receive either setidegrasib (the test medication) or docetaxel (the comparator). The assignment is random, so you will not know in advance which medication you will receive.

  2. Step 2

    Baseline Assessments

    Before the first dose, you will undergo a series of examinations that include blood tests, electrocardiogram (ECG), vital‑sign measurements, and imaging scans of the chest. These tests create a reference point to compare future results.

    Your performance status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well you are able to carry out daily activities.

  3. Step 3

    First Treatment Administration

    If you are assigned to setidegrasib, you will receive a single intravenous (IV) infusion of 600 mg. The medication is prepared as a concentrate that is diluted before the infusion.

    If you are assigned to docetaxel, you will receive an IV infusion of 75 mg per square meter of body‑surface area. The drug is supplied as a solution for infusion.

  4. Step 4

    Regular Treatment Cycles

    You will continue to receive the same medication by IV infusion at the same dose for each treatment cycle. The exact interval between cycles (for example, every three weeks) will be determined by the study protocol and your treating physician.

    Each infusion is administered in a clinical setting where health‑care professionals monitor you for any immediate reactions.

  5. Step 5

    Monitoring and Evaluations

    At scheduled visits, you will have repeat blood tests, ECGs, and vital‑sign checks to assess safety.

    Imaging studies will be performed periodically to evaluate tumor size according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. These scans help determine whether the disease is stable, shrinking, or progressing.

    You will complete questionnaires that ask about symptoms such as coughing, shortness of breath, chest pain, and overall quality of life. These questionnaires are part of the secondary objectives of the trial.

  6. Step 6

    Treatment Discontinuation

    Treatment will stop if the disease shows progression on imaging, if you experience unacceptable side effects, or if you choose to withdraw from the study.

    The study team will discuss the reason for stopping treatment and will arrange any necessary follow‑up care.

  7. Step 7

    Post‑treatment Follow‑up

    After stopping the study medication, you will continue to be followed for survival outcomes. The study will record the date of any death from any cause, which contributes to the measurement of overall survival.

    Periodic check‑ups may be scheduled to collect long‑term safety information and to assess any lasting effects of the treatment.

Who can join the trial?

8 criteria

  • You must be 18 years old or older when you sign the consent form.
  • You must have non‑small cell lung cancer that cannot be removed by surgery or has spread to other parts of the body, and tests must show a specific genetic change called KRAS G12D mutation. The test result must be available before you are assigned to a treatment group. The test can be done on a tissue sample or on a blood sample (called plasma ctDNA).
  • Your cancer must have gotten worse or come back after you received chemotherapy that contains a platinum drug (such as cisplatin or carboplatin) together with an immune‑system drug that blocks PD‑1 or PD‑L1. You must have had this combination treatment in the advanced or metastatic setting, and the disease must have progressed after it.
  • Apart from the allowed medicines, you cannot be receiving other cancer treatments. The only other treatments that are allowed are anti‑VEGF therapy (for example, bevacizumab) if it was given together with the platinum chemotherapy and/or the PD‑1/PD‑L1 drug, and anti‑CTLA‑4 antibodies (for example, ipilimumab or tremelimumab) if they were given together with the PD‑1/PD‑L1 drug (with or without platinum chemotherapy).
  • If you previously had chemotherapy or radiation before surgery (called neoadjuvant or adjuvant therapy) and your cancer came back within 6 months, that previous treatment will count as a line of therapy for eligibility.
  • If you are a woman, you must not be pregnant. If you could become pregnant, you must have a negative pregnancy test and agree to use birth control from the start of the study until at least 6 months after the last dose of setidegrasib (or 2 months after the last dose of docetaxel). You also must not be breastfeeding or planning to donate eggs during the study and for the same time after the last dose.
  • You must agree to give a sample of your tumor tissue and a blood sample (plasma) before the study starts.
  • Your overall health and ability to carry out daily activities must be good, measured by an ECOG performance status of 0 (fully active) or 1 (restricted in physically strenuous activity but able to do light work). This assessment must be done within 7 days before you are randomly assigned to a treatment group.

Who cannot join the trial?

10 criteria

  • Untreated or symptomatic brain (CNS) metastases – cancer that has spread to the brain and has not been treated, or is causing symptoms. Even if there are no symptoms, this condition excludes participation.
  • Known actionable mutation with an approved targeted therapy – having specific gene changes (such as KRAS G12C, EGFR, ALK, ROS1, NTRK, NRG1, BRAF V600E, MET exon 14 skipping, RET, or HER2) for which a special drug already exists.
  • Mixed small‑cell lung cancer and non‑small cell lung cancer (NSCLC) histology – the tumor contains both small‑cell and non‑small cell types under the microscope.
  • Leptomeningeal disease – cancer cells have spread to the thin membranes covering the brain and spinal cord.
  • Another active cancer within the past 2 years – any other cancer that still needs treatment, except for certain skin cancers or early‑stage bladder or cervical/breast cancers that have been cured.
  • Known hepatitis B or hepatitis C infection – testing positive for the viruses that cause liver disease (specific lab results may allow inclusion, but generally this excludes participation).
  • Human immunodeficiency virus (HIV) infection – having HIV that does not meet strict control criteria (no recent opportunistic infection, on antiretroviral therapy for at least 4 weeks, CD4 count ≥ 200 cells/µL, and viral load < 400 copies/mL).
  • Current peripheral neuropathy of grade 2 or higher – moderate to severe nerve damage that causes pain, tingling, or weakness in the hands or feet.
  • Uncontrolled fluid buildup – ongoing pleural effusion (fluid around the lungs), pericardial effusion (fluid around the heart), or ascites (fluid in the abdomen) that requires drainage more often than once a month.
  • Radiation therapy within the last 14 days – having received therapeutic or palliative radiation shortly before the study and not fully recovered from its side effects (except hair loss, which is allowed).
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Investigated drugs

  • Setidegrasib

    is an investigational medicine being tested in this study. It is given through an IV infusion and is designed to treat people with advanced non‑small cell lung cancer that has a specific KRAS G12D mutation. The trial is checking whether setidegrasib can keep the cancer from growing (progression‑free survival) and help patients live longer (overall survival) compared with the standard treatment.

  • Docetaxel

    is a chemotherapy drug that is already used to treat lung cancer. In this study it is given by IV infusion and serves as the standard treatment against which setidegrasib is compared. Researchers are looking at how well docetaxel controls the disease and how long patients survive, to see if the new drug might work better.

What is already known about the treatment

  • Docetaxel

    Docetaxel is given by IV infusion as a clear solution that is injected into a vein over several minutes. It is an approved chemotherapy drug that has been used for many years to treat several cancers, including non‑small cell lung cancer. The medicine works by binding to tiny structures called microtubules inside cells and keeping them from breaking apart, which stops cancer cells from dividing and growing. It belongs to the taxane class of antineoplastic (cancer‑fighting) agents.

  • Setidegrasib

    Setidegrasib is delivered by IV infusion as a concentrate that is mixed with fluid before being given through a vein. It is still an investigational drug and is being studied in clinical trials for patients with KRAS G12D‑mutated lung cancer. The compound blocks the activity of the mutated KRAS protein, preventing the signals that tell cancer cells to grow and survive. It is classified as a targeted small‑molecule inhibitor under development.

Investigated diseases

KRAS G12D‑mutated locally advanced unresectable or metastatic non‑small cell lung cancer - This is a lung cancer that starts in the cells lining the airways and carries a specific KRAS G12D genetic change. It may be too extensive to be removed by surgery (locally advanced unresectable) or it may have spread to other organs (metastatic). The tumor can grow in size and infiltrate nearby structures, and cancer cells may travel to lymph nodes, bone, brain, or other tissues. Common early signs include persistent cough, shortness of breath, and chest discomfort. As the disease progresses, the tumor burden increases and new sites of spread may appear.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524079-22-00Protocol code3082-CL-5301Estimated enrolment356 patientsSponsorAstellas Pharma Global Development Inc.

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