Study on Neoadjuvant KRAS G12C Directed Therapy with Adagrasib, with or without Nivolumab, for Lung Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05472623

Provider View

This clinical trial is testing a new treatment approach using Adagrasib, alone or with Nivolumab, for patients with non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. The study aims to evaluate the safety and effectiveness of these treatments before surgery.

Patient Parameters

Program Overview

This study is exploring the use of Adagrasib, a drug targeting the KRAS G12C mutation, either by itself or combined with the immunotherapy drug Nivolumab, in patients with non-small cell lung cancer (NSCLC) who are eligible for surgery. The goal is to see if these treatments can improve outcomes by reducing the risk of cancer returning after surgery. The trial will assess how safe and effective these treatments are when given before surgery.

Description

About 30% of patients with non-small cell lung cancer (NSCLC) have tumors that can be surgically removed, but many experience cancer returning after surgery. Current treatments before or after surgery have limited success, and new options are needed. This study focuses on patients with a specific mutation in their cancer called KRAS G12C, which is common in NSCLC and linked to smoking. Adagrasib is a new drug that targets this mutation and has shown promise in early studies. The trial will test Adagrasib alone or with Nivolumab, an immunotherapy drug, to see if they can improve outcomes for patients with resectable NSCLC. The study will measure how well the treatments work by looking at the amount of cancer left after surgery and overall survival rates. Researchers hope that combining Adagrasib with Nivolumab will enhance the immune system's ability to fight cancer, leading to better results. This is the first study to test this combination in patients with resectable lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation.
  • Cancer must be at a stage where surgery is an option for potential cure.
  • Have a good performance status, meaning able to carry out daily activities with minimal restrictions.
  • Have adequate organ function based on specific blood tests.
  • Women of childbearing potential must agree to use contraception during the study and for six months after treatment.
  • Must not be pregnant or breastfeeding.
  • Must be willing to provide a tumor sample for testing.
  • Must be able to understand and agree to the study requirements, including signing a consent form.

Exclusion Criteria

  • Cancer that cannot be surgically removed with the intent to cure.
  • Previous treatment for lung cancer, including chemotherapy or targeted therapy for KRAS G12C.
  • Prior radiation to the chest area.
  • Other active cancers requiring treatment, except for certain non-threatening types.
  • Brain metastases at the time of screening.
  • Autoimmune or inflammatory diseases requiring treatment in the past two years (for patients receiving Nivolumab).
  • Use of systemic steroids or immunosuppressive medications recently (for patients receiving Nivolumab).
  • Major surgery within four weeks before starting the study.
  • History of organ transplant or immune system disorders.
  • Uncontrolled HIV or hepatitis B or C infections.
  • Recent heart problems, such as heart attack or unstable heart rhythms.
  • Need for medications that could interfere with the study drugs.
  • Recent stroke or mini-stroke.
  • Conditions affecting the stomach or intestines that could interfere with the study drugs.
  • Pregnant or nursing women.
  • Individuals who are incarcerated or detained.
  • Recent receipt of a live vaccine.

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