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

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What is this study about?

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.

1 Treatment 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.

2 Chemotherapy 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.

3 Pembrolizumab 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.

4 BMS-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.

5 Regular 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.

6 Safety 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.

7 Response 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.

8 Long-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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
CHU Gabriel-Montpied Clermont Ferrand France
Centre hospitalier universitaire de Liege Liege Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Radiotherapy Center Cluj S.R.L. Floresti Romania
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Spitalul Municipal Ploiesti Ploiesti Romania
Mazowiecki Szpital Onkologiczny Sp. z o.o. Wieliszew Poland
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Henry Dunant Hospital Center Athens Greece
Complex Oncology Center Ruse EOOD Ruse Bulgaria
MBAL Trakia EOOD Stara Zagora Bulgaria
Institutul Regional De Oncologie Iasi Iasi Romania
Centrul De Diagnostic Si Tratament Provita S.A. Bucharest Romania
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Regensburg Germany
Bundeswehrkrankenhaus Ulm Ulm Germany
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
General University Hospital Of Larissa Larissa Greece
Centre Hospitalier Regional Universitaire Besançon France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Matrai Gyogyintezet Gyongyos Hungary
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Feldkirch Austria
Semmelweis University Budapest Hungary
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Jessa Ziekenhuis Hasselt Belgium
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Rennes Rennes France
University Hospital Olomouc Olomouc Czechia
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Radiology Therapeutic Center S.R.L. Otopeni Romania
Centre Hospitalier Lyon Sud Pierre Benite France
Vrije Universiteit Brussel Jette Belgium
Roskilde University Roskilde Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Francois Baclesse Caen France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD Haskovo Bulgaria
Lungenfachklinik Immenhausen Immenhausen Germany
Imrchzvb Ranyabar Da Ctowlw Da Myaqrknjrlv Montpellier France
Ovhfbirdvoqkto Lfrf Gfjt Linz Austria
Usokpfyucpkn Mjbpano Cfvpxzp Ghpadrkyk Groningen The Netherlands
Iljjbqgn Cgwvra Dnlllajfaphjdactu L'hospitalet De Llobregat Spain
Opmikazr Sciiu Mnddn dcvpt Clukr Ravenna Italy
Oqhjyhee Sduvk Mqyqa Dxjod Mcosyiefarzw &enovmc Aidjhtt Ogrwldefxxh dd Penidfm Perugia Italy
Laf Mtw Oweagyabu Scd z oedi Warsaw Poland
Apd Ftdl Khyepkdq Geaz Goeppingen Germany
Tqjyautial Ctbhcv Hntkxqro Thessaloniki Greece
Ljsuk Gfkikwz Hraifcon Ob Aikszr Athens Greece
Caiyad Hbeifmcooyt Udjblyflvizrr Dd Dvukn Dijon France
Cokbci Hsamkkdtath Rsislcip Uhedsslhmarnl Dk Tngzo Tours France
Cufd Do Nsrkk Vandoeuvre Les Nancy France
Agjgvnq Uypay Scargxuya Lwgrzi Dg Blrfbcp Bologna Italy
Ukexrpytwy Ox Azcpygv Edegem Belgium
Gntcqb Hdveztfphrl Uzyrzetrubqzu Pysfb Pakagbisuay Er Nepmwtvgnykh Paris France
Hwuckzde Vaws dvzhxzpm Barcelona Spain
Iuaxqbhy Ppllajsvgwpprab Cibccv Clmrir Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
30.10.2025
Belgium Belgium
Recruiting
30.10.2025
Bulgaria Bulgaria
Recruiting
30.10.2025
Czechia Czechia
Recruiting
30.10.2025
Denmark Denmark
Not yet recruiting
30.10.2025
France France
Recruiting
30.10.2025
Germany Germany
Recruiting
30.10.2025
Greece Greece
Not yet recruiting
30.10.2025
Hungary Hungary
Recruiting
30.10.2025
Italy Italy
Recruiting
30.10.2025
Poland Poland
Recruiting
30.10.2025
Romania Romania
Recruiting
30.10.2025
Spain Spain
Recruiting
30.10.2025
Sweden Sweden
Recruiting
30.10.2025
The Netherlands The Netherlands
Recruiting
30.10.2025

Trial locations

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.

Trial ID:
2025-521511-40-00
Protocol code:
CA240-0029
Trial Phase:
Therapeutic use (Phase IV)

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