Study of Adagrasib Dosing in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The trial is testing a medication called Adagrasib, which is taken as a film-coated tablet. Adagrasib is also known by its code name, MRTX849. The purpose of the study is to evaluate how effective two different dosing regimens of Adagrasib are for patients who have already received certain treatments for their cancer.

Participants in the study will receive one of two dosing regimens of Adagrasib. One group will take 600 mg of Adagrasib twice a day without regard to food, while the other group will take 400 mg twice a day with food. The study will monitor how well the cancer responds to these treatments and will also look at the overall survival of the participants, which means the length of time they live after starting the treatment. Additionally, the study will assess how long the treatment keeps the cancer from getting worse and how long any positive response to the treatment lasts.

The trial will also focus on the safety of Adagrasib by observing any side effects that occur during the study. Participants will report any symptoms they experience while taking the medication. The study will continue until 2027, allowing researchers to gather comprehensive data on the effectiveness and safety of Adagrasib for treating NSCLC with the KRAS G12C mutation.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive one of two different dosing regimens of the medication adagrasib.

The study is designed to evaluate the effectiveness of these dosing regimens in treating non-small cell lung cancer with a specific mutation called KRAS G12C.

2 medication administration

If you are in the first group, you will take adagrasib as a 600 mg dose twice a day, without regard to food.

If you are in the second group, you will take adagrasib as a 400 mg dose twice a day, with food.

The medication is provided in the form of a film-coated tablet, which you will take orally.

3 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess how your body is responding to the treatment.

You will be asked to report any symptoms or side effects you experience during the study period.

4 end of treatment

The study will continue until the estimated end date in May 2027, or until you and your doctor decide it is best to stop the treatment.

After the last dose of adagrasib, you will have a follow-up period of 28 days to monitor any lasting effects of the treatment.

Who Can Join the Study?

  • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
  • Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
  • Have recovered from their prior treatment and blood tests are within a safe range.

Who Cannot Join the Study?

  • Patients who have not been diagnosed with non-small cell lung cancer cannot participate.
  • Patients without the KRAS G12C mutation in their cancer cells are excluded. This is a specific change in the cancer’s genetic material.
  • Patients who have not received prior treatment with a platinum-based regimen are excluded. This refers to a type of chemotherapy that includes drugs containing the metal platinum.
  • Patients who have not received immune checkpoint inhibitor therapy are excluded. This is a treatment that helps the immune system recognize and attack cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medisprof S.R.L. Cluj Napoca Romania
Koranyi National Institute For Pulmonology Budapest Hungary
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Sigmedical Services S.R.L. Suceava Romania
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Netherlands Cancer Institute Amsterdam The Netherlands
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Azienda Ospedaliera Di Perugia Perugia Italy
Oncolab S.R.L. Craiova Romania
MD Anderson Cancer Center Madrid Spain
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
University Of Debrecen Debrecen Hungary
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Alexandra Hospital Athens Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Universidade De Santiago De Compostela Santiago De Compostela Spain
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Specijalna Bolnica Medico Rijeka Croatia
Groupe Hospitalier Bretagne Sud Lorient France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
St. Luke’s Hospital S.A. Thessaloniki Greece
Servei De Salut De Les Illes Balears Palma Spain
Institut de Cancérologie de l’Ouest Saint-Herblain France
Direction Centrale Du Service De Sante Des Armees Toulon France
Les Hopitaux Nord-Ouest Villefranche sur Saône France
Iwrddo Ipzsrwaz Fvplarxdrxqdz Ouyuzgorole Rome Italy
Wrwxhzxjoau Wkxmuwbdvkxnhqvbzpng Czakufn Ombjavgtc I Tvxnzxsjgumyl Iw Mhsikjyrkhh W Lbhaf Lodz Poland
Sbruitix Povykbfiz Sxj z ooap Gdynia Poland
Uglroijnwa Hkmfetfc Cxyxkv Zojemr Zagreb Croatia
Mu Piqhery Jqqdiz Mrvaqznwrv Kapywxfyn Sniadakhphvpmrltum Ssoimb Jdwvw Lublin Poland
Tobpnttglu Cebchg Hyrpwamy Thessaloniki Greece
Alulovvthm Pbrkwtzo Hmrwosak De Mjveyzdtn Marseille France
Htblzfpy Dl Lv Stljq Cwdw I Sbgm Ply Barcelona Spain
Gfbzgp Hlhsbesyqoj Ucmxrfcrjmwsi Pqprf Pqdvotgbtlx Eq Nizyflgqpbja Paris France
Cwyhwx Hyyawwpchwa Renaimvi Dupzizteibxntn Angers France
Himqlhye Vsvt dstnitjj Barcelona Spain
Unifkyzgad Ghlmlci Hkqlxhud Aflpwrx Athens Greece

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

Trial status

Country Status Recruitment Start
Croatia Croatia
Not recruiting
24.11.2023
France France
Not recruiting
24.11.2023
Greece Greece
Not recruiting
24.11.2023
Hungary Hungary
Not recruiting
24.11.2023
Italy Italy
Not recruiting
24.11.2023
Poland Poland
Not recruiting
24.11.2023
Romania Romania
Not recruiting
24.11.2023
Spain Spain
Not recruiting
24.11.2023
The Netherlands The Netherlands
Not recruiting
24.11.2023

Trial locations

Investigated drugs:

Adagrasib is a medication being studied for its potential to treat non-small cell lung cancer, specifically in patients who have a mutation known as KRAS G12C. This medication works by targeting and blocking the activity of the KRAS G12C protein, which is involved in the growth and spread of cancer cells. By inhibiting this protein, adagrasib aims to slow down or stop the progression of the cancer. The study is exploring how effective adagrasib is when taken in different ways, either with or without food, to find the best approach for patients who have already received other cancer treatments, such as chemotherapy and immune therapy.

Non-small cell lung cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. NSCLC often grows and spreads more slowly than small cell lung cancer, another major type of lung cancer. The progression of NSCLC can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage due to the subtlety of early symptoms.

Trial ID:
2023-503523-25-00
Protocol code:
849-021
NCT ID:
NCT05853575
Trial Phase:
Therapeutic exploratory (Phase II)

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