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Study of STK-012 Alone and Combined with Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

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What is this trial about?

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

This study is looking at non-small cell lung cancer, which is a type of cancer that affects the lungs. The study will test a treatment called STK-012, which is an experimental medicine that will be given as an injection under the skin. This medicine will be tested both on its own and in combination with other cancer treatments. The other treatments that may be used in this study include pembrolizumab, which is given through a vein and helps the immune system fight cancer, pemetrexed, which is a chemotherapy medicine also given through a vein, and carboplatin, which is another chemotherapy medicine given through a vein. Some people in the study will receive STK-012 together with chemotherapy, while others will receive only chemotherapy for comparison.

The purpose of this study is to compare how well the combination of STK-012 with chemotherapy works compared to chemotherapy alone in people whose cancer has a specific characteristic related to a marker called PD-L1. The study will look at how many people respond to the treatment, meaning their tumors shrink or disappear. During the study, participants will receive their assigned treatment over a period of time, with regular check-ups to monitor how the cancer is responding and to check for any side effects. The study will also measure how long people live without their cancer getting worse and how long they live overall. Blood tests and other assessments will be done to understand how the experimental medicine works in the body and whether it causes the body to produce antibodies against it.

This study is designed for people who have advanced lung cancer that has spread to other parts of the body or cannot be treated with surgery or radiation. Participants must not have received previous treatment for their advanced cancer, although they may have had treatment after surgery if it was completed more than six months before joining the study. The study will include people whose tumors do not have certain genetic changes for which other standard treatments are available. Participants will need to be well enough to carry out normal daily activities and have adequate organ function based on blood tests.

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
Initial screening and baseline assessments
Your doctor will perform tests to confirm that your body's organs are working properly. These tests must be completed within 28 days before starting treatment.
If you are a woman who can become pregnant, you will need a pregnancy test within 72 hours before receiving the first dose of treatment. The test must be negative to participate.
Your doctor will assess your ability to carry out daily activities using a scale called Eastern Cooperative Oncology Group performance status, which measures how the disease affects your daily living abilities. Your score must be 0 or 1, meaning you are fully active or restricted in physically strenuous activity but able to carry out light work.
Your tumor will be tested to confirm it is non-squamous non-small cell lung cancer at stage IV or stage IIIB/IIIC. The tumor must not contain small cell, neuroendocrine, or sarcomatoid components.
Your tumor will be tested for PD-L1, a protein found on some cancer cells. Your tumor must be negative for PD-L1, with a score of less than 1%.
Your tumor will be tested to ensure it does not have specific genetic changes in EGFR, ALK, or ROS1 genes, or other genetic changes for which standard treatment is available as first-line therapy.
Your disease must be measurable according to specific criteria called RECIST 1.1, which means there are tumors that can be measured and tracked over time.
Step 2
Treatment assignment
You will be assigned to one of the treatment groups. The study will compare different treatment combinations.
One group will receive STK-012 at a dose of 2.25 mg combined with standard chemotherapy.
Another group will receive standard chemotherapy alone, which consists of carboplatin, pemetrexed, and pembrolizumab.
The assignment to a treatment group will be done randomly, meaning neither you nor your doctor can choose which treatment you receive.
Step 3
Treatment administration
If you are assigned to receive STK-012, it will be given as an injection under the skin, which is called a subcutaneous injection.
The chemotherapy medications (carboplatin, pemetrexed, and pembrolizumab) will be given through a vein, which is called an intravenous infusion.
Your treatment will be given in cycles. Each cycle typically lasts 21 days, meaning you will receive treatment every three weeks.
The exact number of cycles and duration of treatment will depend on how your body responds to the treatment and whether you experience any side effects.
Step 4
Monitoring during treatment
Throughout the study, your doctor will regularly check your tumor size using imaging scans to see if the treatment is working. This assessment will be done by independent reviewers who do not know which treatment you are receiving.
Your doctor will monitor you for any side effects or unwanted reactions to the treatment. These will be recorded and graded according to a standard system called NCI CTCAE version 5.0.
If you experience cytokine release syndrome, a specific type of reaction that can occur with certain cancer treatments, it will be graded using different guidelines called ASTCT guidelines.
Blood samples will be taken to measure the levels of STK-012 in your body, if you are receiving this medication. This helps understand how your body processes the medication.
Your blood will also be tested to see if your body develops antibodies against STK-012, which are proteins your immune system might create in response to the medication.
Regular laboratory tests will be performed to check your organ function and blood counts throughout the treatment period.
Step 5
Response assessment
The main goal of the study is to measure the overall response rate, which is the percentage of patients whose tumors shrink significantly or disappear completely.
A complete response means all signs of cancer have disappeared.
A partial response means the tumor has shrunk by a certain amount but has not completely disappeared.
Independent reviewers who do not know which treatment you received will assess your tumor response to ensure the evaluation is unbiased.
Step 6
Long-term follow-up
Your doctor will track the time from when you started treatment until your disease progresses or you pass away, whichever happens first. This is called progression-free survival.
The study will also track overall survival, which is the time from when you started treatment until death from any cause.
If you are a woman of childbearing potential, you must use highly effective birth control methods during treatment and for 180 days after your last dose.
If you are a man with a female partner who can become pregnant, you must use highly effective birth control methods or a condom with spermicide during treatment and for 180 days after your last dose. You must not donate sperm during this time.
Your participation in the study will continue according to the scheduled assessments until the study ends or until you are no longer able to participate.

Who can join the trial?

17 criteria

You must provide written permission to take part in the study and agree to follow all study procedures.
You must be at least 18 years old when you sign the permission form.
You must be expected to live longer than 3 months as determined by your doctor.
You must have measurable disease, which means tumors that can be seen and measured on scans using a standard method called RECIST 1.1. If you had radiation treatment to an area before, tumors in that area can be measured only if they have grown since the radiation.
Your general physical condition must be good, rated as 0 or 1 on a scale called ECOG performance status, which means you are able to carry out normal activities or have only minor symptoms.
Your organs must be working well enough, as shown by blood tests done within 28 days before starting treatment.
If you are a woman who can become pregnant, you must agree to use a very reliable method of birth control as described in the study rules.
If you are a woman who can become pregnant, you must have a negative pregnancy test within 72 hours before receiving the first dose of study treatment.
If you are a man with a female partner who can become pregnant, you must agree to use very reliable methods of birth control as described in the study rules, or use a condom plus spermicide. You must also agree not to donate sperm during treatment and for 180 days after your last dose.
If you are a man whose only birth control method is condom plus spermicide, your female partner who can become pregnant must also use a very reliable method of birth control during your treatment and for 180 days after your last dose.
You must be able and willing to complete the entire study following the required schedule of visits and tests.
You must have a confirmed diagnosis through tissue or cell examination showing stage IV disease (cancer that has spread to distant parts of the body) or stage IIIB/IIIC disease (locally advanced cancer with certain lymph node involvement) of non-squamous non-small cell lung cancer, and if you have stage IIIB/IIIC, you must not be suitable for definitive treatment such as surgery or radiation with curative intent.
Your tumor must be mainly non-squamous cell type of non-small cell lung cancer. Your tumor must not contain small cell, neuroendocrine (a type of hormone-producing cell), or sarcomatoid (a rare cancer type) components.
Your tumor must not have certain specific genetic changes called actionable genetic alterations in genes named EGFR, ALK, or ROS1, or other genetic changes for which there is a standard approved treatment available as first treatment in your area.
Your tumor must test negative for PD-L1, which means it has a score of less than 1 percent on a test that measures a specific protein on cancer cells.
You must not have received any prior treatment with medications given through the bloodstream for your advanced non-squamous non-small cell lung cancer.
If you received chemotherapy after surgery to prevent cancer from returning, or before surgery to shrink the tumor, or after radiation to eliminate remaining cancer cells, you can participate only if that treatment was completed more than 6 months before starting this study. You must not have received any prior treatment with drugs called immune checkpoint inhibitors in these settings.

Who cannot join the trial?

4 criteria

The study information provided does not list specific reasons why patients cannot participate in this clinical trial
If you are considering joining this study, the research team will need to review your complete medical history and current health status to determine if you are eligible
General factors that often prevent participation in cancer studies may include having other serious medical conditions, being pregnant or breastfeeding, having received certain previous treatments, or having abnormal results in blood tests or organ function tests
The specific exclusion criteria, which are the medical reasons that would prevent you from joining, will be discussed with you directly by the study doctors during the screening process

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Verified sites

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

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Verified
Catania, Italy
Azienda Unita Sanitaria Locale Della Romagna
Verified
Faenza, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

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Investigated drugs

STK-012
is an investigational medication being studied in this clinical trial. It is being tested both alone and in combination with other treatments for patients with advanced non-small cell lung cancer and other selected conditions. In this study, it is being given at a specific dose together with chemotherapy to see how well it works compared to chemotherapy alone.
Chemotherapy
is a standard cancer treatment that uses drugs to stop or slow the growth of cancer cells. In this trial, chemotherapy is being used as a comparison treatment and also in combination with the investigational medication STK-012.

What is already known about the treatment

STK-012 – STK-012 is an investigational medication currently being studied in clinical trials for the treatment of non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. The drug is being tested as a single treatment and in combination with chemotherapy, particularly in patients whose cancer cells do not express high levels of a protein called PD-L1. While the exact mechanism of action has not been fully disclosed in the available information, STK-012 is being evaluated to determine if it can improve tumor response rates when added to standard chemotherapy treatments in patients with advanced lung cancer who have not yet received treatment for their disease.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease occurs when cells in the lung tissue start growing abnormally and uncontrollably, forming tumors. As the cancer progresses, these abnormal cells can spread to nearby tissues and lymph nodes. In more advanced stages, the cancer may spread to other parts of the body through the bloodstream or lymphatic system. The disease can interfere with normal lung function, making it difficult for the lungs to work properly. Non-small cell lung cancer grows and spreads more slowly compared to small cell lung cancer.