Comparing Setidegrasib (ASP3082) and Docetaxel for Non-small Cell Lung Cancer with KRAS G12D Mutation

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT07566052

This study is testing a new drug, Setidegrasib, against the standard treatment, Docetaxel, for people with non-small cell lung cancer (NSCLC) that has a specific gene mutation called KRAS G12D. The goal is to see if Setidegrasib can help patients live longer without their cancer getting worse.

Patient Parameters

Parameter	Options

Program Overview

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. It is usually treated first with chemotherapy and another treatment that targets specific proteins on cancer cells. If the cancer worsens, the next treatment is often a drug called Docetaxel, but it doesn't work for long in most cases. This study is exploring a new drug, Setidegrasib, which may help by removing abnormal proteins caused by a faulty KRAS gene, specifically the G12D mutation. The study will compare how long patients live without their cancer worsening when treated with Setidegrasib versus Docetaxel. It will also look at tumor response, symptoms, and how the body processes Setidegrasib.

Description

In this study, adults with advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body, and who have a specific KRAS G12D mutation, will participate. Participants will be randomly assigned to receive either Setidegrasib or Docetaxel. The treatment is given through an infusion into a vein. The study will continue until the cancer worsens, the treatment is not tolerated, other cancer treatments start, or the participant or doctor decides to stop. Participants on Docetaxel may switch to Setidegrasib if their cancer worsens. Regular safety checks and tumor scans will be conducted. After the cancer worsens, follow-up calls will be made every 12 weeks to check on participants.

Eligibility Criteria

Inclusion Criteria

Have advanced non-small cell lung cancer (NSCLC) with a KRAS G12D mutation.
Have had no more than two previous treatments for cancer.
Must have progressed after platinum-based chemotherapy combined with anti-PD-1/PD-L1 therapy.
Women must not be pregnant and agree to use contraception during and after treatment.
Must provide a tumor and blood sample before starting the study.
Have a performance status that allows for daily activities with some restrictions.

Exclusion Criteria

Have untreated or symptomatic brain metastases.
Have a different type of lung cancer mixed with NSCLC.
Have cancer that has spread to the brain's covering tissue (leptomeningeal disease).
Have had another active cancer in the past two years, except for certain skin or localized cancers.
Have active hepatitis B or C infections.
Have HIV but not on stable treatment.
Have severe nerve damage (neuropathy).
Have uncontrolled fluid buildup in the body requiring frequent drainage.
Have received radiation therapy within 14 days before starting the study.
Have a known mutation that can be treated with available targeted therapies.
Have previously been treated with Docetaxel or a KRAS-targeting drug.
Require medications that strongly affect liver enzymes.

Locations

FACILITY	ZIP	CITY	STATE
Oncura Health d.b.a.Los Angeles Cancer Network	91204	Glendale	California
Virginia Cancer Specialists	22201	Arlington	Virginia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.