A Study of BMS-986504 with Drug Combination Compared to Placebo with Drug Combination in Patients with Advanced Non-Small Cell Lung Cancer Starting First Treatment
This study is looking at metastatic non-small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body. The study is specifically for people whose cancer has a particular genetic change called homozygous MTAP deletion, which means a specific gene is missing from both copies of the chromosome in the cancer cells. The treatments being tested include BMS-986504, which is an experimental medicine given as a tablet by mouth, along with pembrolizumab, which is a medicine given through a vein that helps the immune system fight cancer. The study also includes chemotherapy medicines that are given through a vein, such as paclitaxel, paclitaxel albumin-bound, carboplatin, cisplatin, and pemetrexed. Some participants will receive a placebo instead of BMS-986504, which is an inactive substance that looks like the real medicine but contains no active ingredient.
The purpose of the study is to find out if adding BMS-986504 to pembrolizumab and chemotherapy can help people with this type of lung cancer live longer without their cancer getting worse, and to see if it can help them live longer overall, compared to treatment with placebo plus pembrolizumab and chemotherapy. The study will also look at how well the cancer responds to treatment and how long any response lasts, as well as checking for any unwanted effects that the treatments may cause.
The study will be conducted in two phases. Participants will be randomly assigned to receive either BMS-986504 or placebo, both given together with pembrolizumab and chemotherapy. The specific chemotherapy medicines used will depend on the type of lung cancer each person has. Throughout the study, doctors will perform regular check-ups and scans to see how the cancer is responding to treatment and to monitor for any side effects. Treatment will continue for as long as it is helping and not causing unacceptable side effects.
1Treatment assignment
Upon joining the study, you will be randomly assigned to one of two treatment groups. This random assignment is similar to flipping a coin and ensures fairness in the study.
One group will receive BMS-986504 (also called MRTX1719) combined with pembrolizumab and chemotherapy. The other group will receive a placebo (an inactive substance with no medication) combined with pembrolizumab and chemotherapy.
2Chemotherapy treatment
You will receive chemotherapy as part of your treatment. The specific chemotherapy medications may include paclitaxel, paclitaxel albumin-bound, carboplatin, cisplatin, or pemetrexed.
These medications will be given to you through a vein (intravenous administration).
The exact combination, dosage, frequency, and duration of chemotherapy will be determined based on your specific treatment plan.
3Pembrolizumab treatment
You will receive pembrolizumab, which is a type of immunotherapy medication that helps your immune system fight cancer cells.
This medication will be given to you through a vein (intravenous administration).
The dosage, frequency, and duration will be determined according to the study protocol.
4BMS-986504 or placebo treatment
Depending on your assigned treatment group, you will receive either BMS-986504 (also known as MRTX1719) or a placebo.
BMS-986504 is an investigational medication being tested in this study. It may be given as a tablet by mouth (oral use) or through a vein (intravenous use).
If you receive the placebo, it will look identical to the active medication but contains no active ingredients.
The dosage, frequency, and duration will follow the study protocol.
5Regular monitoring and assessments
Throughout the study, you will undergo regular monitoring to assess how the treatment is working and to check for any side effects.
This will include imaging scans to measure your tumor size according to RECIST v1.1 criteria, which is a standardized method for evaluating whether tumors are shrinking, staying the same, or growing.
Your doctor will monitor for progression free survival, which means the length of time during and after treatment that your cancer does not get worse.
Blood tests and other laboratory assessments will be performed to monitor your overall health and detect any abnormalities.
6Safety monitoring
Your medical team will continuously monitor you for any adverse events, which are unwanted or harmful reactions that may occur during treatment.
This includes monitoring for both mild and serious side effects, as well as any reactions that may be related to the study medications.
If you experience side effects, your treatment may be adjusted, including dose interruptions, dose reductions, or discontinuation of the study medication if necessary.
All safety concerns will be documented and managed appropriately throughout your participation.
7Response evaluation
Your response to treatment will be evaluated regularly to determine if the cancer is responding to therapy.
The medical team will assess objective response, which means whether your tumor has shrunk significantly.
Disease control will be measured, which indicates whether the treatment is keeping the cancer from getting worse.
The time to objective response (how long it takes for the tumor to respond) and duration of response (how long the response lasts) will also be recorded.
8Long-term follow-up
After completing the active treatment phase, you will continue to be followed for long-term outcomes.
This includes monitoring your overall survival, which is the length of time you remain alive after starting treatment.
The study team will also track PFS2, which measures the time from starting treatment until your cancer progresses again after any subsequent therapy.
The study is expected to continue until August 2031, though your individual participation duration may vary.
Who Can Join the Study?
Age and consent:
You must be at least 18 years old or the legal age to give consent in your area at the time of signing the consent form
Type and stage of cancer:
You must have metastatic non-small cell lung cancer, which means lung cancer that has spread to other parts of the body and is classified as Stage IV or has come back after treatment
You must not have received any previous treatment for your cancer after it has spread to other parts of the body
Laboratory tests and tumor characteristics:
Your cancer must be confirmed through a tissue sample examined under a microscope
Your tumor must show a specific genetic change called MTAP deletion or MTAP loss, which means a particular gene is missing or not working in your cancer cells
Physical condition:
You must have an ECOG performance status of 0 or 1, which is a score that measures how well you can perform daily activities. A score of 0 means you are fully active, and a score of 1 means you can do light work but cannot do strenuous physical activity
Measurable disease:
You must have at least one tumor that can be measured on imaging scans according to specific guidelines called RECIST v1.1, which are standard rules used to track tumor size during treatment
Who Cannot Join the Study?
The specific exclusion criteria (reasons why you cannot join this study) have not been provided in the available information
Generally, clinical trials have rules about who cannot participate to ensure the safety of patients and the accuracy of the study results
Common reasons patients may not be able to join cancer studies include having other serious medical conditions, being pregnant or breastfeeding, having received certain treatments recently, or having specific test results that fall outside acceptable ranges
Your doctor will review all requirements with you to determine if you are eligible to participate in this particular study
BMS-986504 is an investigational medication being studied in this trial. It will be given in combination with other cancer treatments to see if it helps patients with a specific type of lung cancer that has a particular genetic change called homozygous MTAP deletion.
Pembrolizumab is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents immune cells from attacking the cancer, allowing your body’s natural defenses to work better against the tumor.
Chemotherapy refers to standard cancer-fighting medications that work by killing rapidly dividing cells, including cancer cells. The specific chemotherapy drugs will be chosen based on your type of lung cancer and will be given along with the other study medications.
Metastatic Non-Small Cell Lung Cancer – This is an advanced form of lung cancer that has spread from the lungs to other parts of the body. Non-small cell lung cancer is the most common type of lung cancer, accounting for most cases. The disease begins when cells in the lung tissue start growing abnormally and uncontrollably. When the cancer becomes metastatic, it means the cancer cells have traveled through the bloodstream or lymphatic system to distant organs. Common sites where this cancer spreads include the bones, brain, liver, and adrenal glands. As the disease progresses, it can cause breathing difficulties, chest pain, persistent cough, and weight loss.
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