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Comparing Sotorasib and Pembrolizumab with chemotherapy for patients with advanced non-small cell lung cancer and a KRAS G12C mutation

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on individuals with Nonsquamous Non-Small Cell Lung Cancer, a type of lung cancer, specifically those at stage IV or advanced stage IIIB/C. The research is for patients whose tumors do not show high levels of PD-L1, a protein used to help the immune system find cancer, and instead have a specific genetic change known as a KRAS p.G12C mutation. The purpose of the study is to compare the effectiveness of two different treatment approaches used as a first-line therapy.

One group will receive sotorasib combined with a platinum doublet, which refers to a combination of two drugs like carboplatin and pemetrexed. The other group will receive pembrolizumab along with the same platinum doublet. Other medications, such as folic acid, hydroxocobalamin, dexamethasone, and antiemetics, may be used to support the treatment and manage side effects. During the study, the time until the cancer grows or worsens and the total length of time patients live are monitored.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomization</b>

    At the start of the study, a process called randomization occurs. this determines which treatment group is assigned to you.

    You will be assigned to receive either sotorasib combined with chemotherapy or pembrolizumab combined with chemotherapy.

  2. Step 2

    <b>treatment phase</b>

    If assigned to the sotorasib group, you will take sotorasib by mouth (orally). this is the study medication.

    If assigned to the pembrolizumab group, you will receive pembrolizumab through an intravenous infusion (a medicine delivered directly into a vein).

    In both groups, chemotherapy is administered as part of the treatment. this includes pemetrexed and carboplatin, which are given through an intravenous infusion.

    Additional background medications may be provided, such as folic acid (taken orally), hydroxocobalamin (given as an intramuscular injection into a muscle), dexamethasone (taken orally), and antiemetics (medicines used to prevent nausea, taken orally).

  3. Step 3

    <b>monitoring and evaluation</b>

    The progress of the disease is monitored to determine progression-free survival. this is the length of time from randomization until the cancer gets worse or death occurs.

    The effectiveness of the treatment is also measured by looking for an objective response. this means checking if there is a complete response (all signs of cancer disappear) or a partial response (the amount of cancer in the body decreases).

    If a response is seen, a confirmatory scan is performed 4 weeks after the initial response to confirm the results.

    overall survival is also tracked, which is the total length of time from randomization until death from any cause.

Who can join the trial?

7 criteria

  • You must be a man or a woman who is 18 years of age or older.
  • You must have a confirmed diagnosis of nonsquamous non-small cell lung cancer, which is a specific type of lung cancer that does not start in the mucus-producing cells.
  • Your cancer must be at Stage IV or advanced Stage IIIB/C, meaning the cancer is at an advanced stage and has spread or is growing significantly.
  • Tests must show you have a specific genetic change called a KRAS p.G12C mutation, which is a change in the protein that helps cancer cells grow.
  • Tests must show that your cancer is negative for PD-L1, which means a specific protein used by cancer cells to hide from the immune system is not present in large amounts.
  • You must not have previously received systemic anticancer therapy, which refers to medicines like chemotherapy that travel through the entire body, to treat cancer that has spread or cannot be cured.
  • You must have an ECOG score of 1 or less, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.

Who cannot join the trial?

6 criteria

  • You cannot participate if your lung cancer is a mixed histology type, which means the cancer cells are a mix of different types, or if it contains small-cell or large-cell neuroendocrine cells (specific types of fast-growing cancer cells), or if it is mostly squamous cell (a specific type of cancer cell found in the lining of organs).
  • You are excluded if your tumor has molecular alterations, which are specific changes or mutations in the cancer's DNA, that can already be treated with a targeted therapy (a medicine designed to attack a specific part of a cancer cell) that is approved in your area.
  • You cannot join if you have brain metastases, which means the cancer has spread to the brain, and it is causing symptoms (physical signs of illness) whether it has been treated or not.
  • You are excluded if you have gastrointestinal (GI) tract disease, which is any illness affecting your digestive system (such as the stomach or intestines), that makes it impossible for you to swallow or take medicine by mouth.
  • You cannot participate if you have had a myocardial infarction, commonly known as a heart attack, within the last 6 months, or if you have unstable arrhythmias (irregular heartbeats that are not controlled) or unstable angina (chest pain caused by reduced blood flow to the heart that is changing or worsening).
  • You are excluded if you have previously received treatment using a KRAS G12C inhibitor, which is a specific type of drug designed to block a particular mutation in the cancer.
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Investigated drugs

  • Sotorasib

    is the main experimental treatment being tested in this study. It is a pill taken by mouth and is being studied to see how well it works when combined with chemotherapy to treat certain types of advanced lung cancer.

  • Pembrolizumab

    is a medication used as a comparison in this study. It is given through an IV (into a vein) and is part of a treatment plan used to compare against the experimental therapy to see which is more effective for patients with this specific type of lung cancer.

What is already known about the treatment

  • Pemetrexed

    This medication is an antineoplastic agent administered through an intravenous injection. It is currently used in standard medical practice to treat various types of cancer, including certain lung cancers. The drug works by blocking specific enzymes that cancer cells need to produce DNA and grow. It is pharmacologically classified as an antifolate chemotherapy medication.

  • Carboplatin

    This substance is a chemotherapy drug given to patients via intravenous infusion. It is widely established in medical literature for treating several types of solid tumors. The medication works by attaching to and damaging the DNA within cancer cells, which prevents them from dividing and multiplying. It belongs to a pharmacological class known as platinum-based antineoplastic agents.

  • Sotorasib

    This medication is taken orally as a pill and is currently used to treat specific advanced lung cancers. It is a targeted therapy that works by specifically binding to and turning off a mutated protein called KRAS G12C, which otherwise signals cancer cells to grow uncontrollably. This drug is pharmacologically classified as a KRAS inhibitor.

  • Calcium folinate

    This substance is administered orally to support patients undergoing certain cancer treatments. It is commonly used in medicine to help reduce the side effects caused by other chemotherapy drugs. The medication works by providing a source of folate that helps healthy cells recover from the damage caused by treatment. It is pharmacologically classified as a vitamin supplement or leucovorin.

  • Hydroxocobalamin

    This medication is given through an intramuscular injection and is used as a form of Vitamin B12. It is medically used to treat vitamin deficiencies or to counteract certain types of poisoning. At a molecular level, it helps support essential metabolic processes and nerve function within the body. It is pharmacologically classified as a vitamin supplement.

  • Pembrolizumab

    This medication is administered through an intravenous infusion and is an established treatment for many types of cancer. It works by blocking a specific protein on immune cells that prevents them from attacking cancer cells, thereby helping the body's own immune system fight the disease. It is pharmacologically classified as an immune checkpoint inhibitor.

Investigated diseases

Non-small cell lung cancer - This is a type of lung cancer that starts in the cells lining the inside of the lungs. It is the most common form of lung cancer and can involve different types of cells. The disease progresses as abnormal cells grow and multiply uncontrollably within the lung tissue. Over time, these cells may spread to nearby tissues or other parts of the body. In advanced stages, the cancer can involve several regions or distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501863-41-00Protocol code20190341Estimated enrolment721 patientsSponsorAmgen Inc.

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