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.

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.

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.

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.

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.

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.