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Study on Sotorasib for Patients with Unresectable Stage III Non-Small Cell Lung Cancer with KRAS Mutation

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What is this trial about?

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

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that cannot be removed by surgery. Specifically, it targets a mutation called KRAS p.G12C found in some patients with this cancer. The treatment being tested is a medication called Sotorasib, also known by its code name AMG 510. This medication is taken in the form of film-coated tablets.

The purpose of the study is to evaluate how effective Sotorasib is in treating this specific type of lung cancer. Participants will receive the medication and will be monitored over time to see how their cancer responds. The study will look at how long patients can live without their cancer getting worse, as well as other outcomes like overall survival and the safety of the treatment.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their cancer. These tests may include imaging scans like PET-CT and MRI to ensure the cancer has not spread to other parts of the body. The study aims to provide valuable information on the potential benefits of Sotorasib for patients with this specific lung cancer mutation.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the investigational nature of the trial and will sign a written informed consent.
A baseline PET-CT scan is mandatory to confirm the absence of distant disease and to verify that the disease is not operable.
Step 2
Initial assessments
The patient will undergo a series of initial assessments, including a brain CT or MRI, to ensure eligibility and to establish a baseline for future comparisons.
Histological confirmation of mediastinal adenopathies is required unless the lymph node mass is indistinguishable.
Step 3
Induction treatment
The patient will begin induction treatment with Sotorasib, administered as LUMYKRAS 120 mg film-coated tablets for oral use.
The dosage and frequency of administration will be determined by the study protocol.
Step 4
Post-induction treatment
Following the induction phase, the patient will continue treatment with Sotorasib to evaluate its effectiveness in maintaining disease control.
Progression-free survival at 12 months will be assessed to determine the treatment's efficacy.
Step 5
Ongoing assessments
Throughout the trial, regular assessments will be conducted to monitor the patient's response to treatment and to identify any potential side effects.
These assessments will include imaging studies and laboratory tests as specified in the study protocol.
Step 6
Completion of the trial
The trial is expected to continue until 2028, with the patient's participation lasting as long as the treatment is deemed beneficial and safe.
Upon completion, the patient's overall response rate and survival will be evaluated.

Who can join the trial?

18 criteria

Must be a male or female aged 18 years or older.
Must have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a confirmed diagnosis of unresectable Stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery.
Must have received radiotherapy before joining the trial and recovered from all related side effects, except for hair loss.
Must have a specific genetic mutation called KRAS p.G12C confirmed before joining the trial.
Must have a life expectancy of at least 12 weeks.
Must undergo a PET-CT scan at the start to confirm the absence of cancer spread and that the cancer cannot be removed by surgery.
Must have mediastinal adenopathies (swollen lymph nodes in the chest) confirmed by a tissue test, unless the lymph node mass is indistinguishable.
Must have a brain CT or MRI scan.
Must have at least one measurable lesion, which is a tumor that can be measured in size.
Must have adequate blood and organ function based on specific lab tests done within 14 days before joining the trial.
Must be informed about the study and sign a written consent form agreeing to participate.
Must be willing and able to attend scheduled visits and follow study procedures.
Female patients of childbearing potential must have a negative pregnancy test before joining the trial.
Female patients of childbearing potential must agree to use effective birth control methods during the study and for 7 days after the last dose of the study drug.
Male patients with female partners of childbearing potential must agree to use effective birth control methods during the study and for 7 days after the last dose of the study drug.
Women who are not postmenopausal or surgically sterile must have a negative pregnancy test before joining the trial.
The QTc interval, a measure of heart rhythm, must be within a certain range based on an average of three ECG tests.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital General Universitario De Valencia
Verified
Valencia, Spain
Hospital Universitario De Jaen
Responsive
Jaen, Spain

Trial locations

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Investigated drugs

Sotorasib: This medication is being studied for its effectiveness in treating patients with a specific type of lung cancer known as stage III unresectable non-small cell lung cancer (NSCLC) with a KRAS p.G12C mutation. Sotorasib works by targeting and inhibiting the KRAS p.G12C protein, which is involved in the growth and survival of cancer cells. The trial aims to assess how well Sotorasib can stop the cancer from progressing over a period of 12 months.

Sotorasib

What is already known about the treatment

Sotorasib – Sotorasib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating certain types of lung cancer, specifically unresectable stage III non-small cell lung cancer with a specific genetic mutation known as KRAS p.G12C. The main therapeutic indication for Sotorasib is to target and inhibit the KRAS p.G12C mutation, which is a common driver of cancer cell growth in this type of lung cancer. At the molecular level, Sotorasib works by binding to the KRAS p.G12C protein, thereby blocking its activity and preventing the cancer cells from proliferating. It is classified pharmacologically as a KRAS inhibitor.

Investigated diseases

Unresectable Stage III KRAS p.G12C Non-Small Cell Lung Cancer – This is a type of lung cancer that cannot be removed through surgery and is characterized by a specific genetic mutation known as KRAS p.G12C. It falls under stage III, which means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. The progression of this disease involves the growth and spread of cancer cells within the lungs and potentially to nearby structures. As the disease advances, it may cause symptoms such as persistent cough, chest pain, and difficulty breathing. The focus of treatment is often on managing symptoms and slowing the progression of the disease.