Study Comparing Divarasib, Sotorasib, and Adagrasib for Patients with Advanced or Metastatic KRAS G12C-Positive Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as KRAS G12C-positive advanced or metastatic non-small cell lung cancer. This is a form of lung cancer that has a specific genetic mutation called KRAS G12C, which can make the cancer more challenging to treat. The study is comparing the effectiveness and safety of a new treatment called divarasib against two existing treatments, sotorasib and adagrasib. These treatments are designed to target the KRAS G12C mutation and are taken as film-coated tablets.

The purpose of the study is to evaluate how well these treatments work in preventing the cancer from getting worse, which is known as progression-free survival. Participants in the study will be randomly assigned to receive either divarasib, sotorasib, adagrasib, or a placebo. The study will monitor the participants over a period of time to see how the treatments affect their cancer and overall health. This includes looking at how long the treatments can keep the cancer from progressing and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to assess their health and the status of their cancer. The study aims to provide valuable information on the best treatment options for patients with KRAS G12C-positive advanced or metastatic non-small cell lung cancer, potentially leading to improved outcomes for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the effectiveness of divarasib compared to other treatments like sotorasib or adagrasib for a specific type of lung cancer.

The patient will be required to provide a tumor tissue sample to confirm the presence of a KRAS G12C mutation.

2 treatment assignment

The patient will be randomly assigned to receive either divarasib, sotorasib, or adagrasib.

All medications are administered orally in the form of film-coated tablets.

3 medication administration

If assigned to LUMYKRAS (sotorasib), the patient will take 120 mg tablets.

If assigned to KRAZATI (adagrasib), the patient will take 200 mg tablets.

The specific dosage and frequency will be determined by the study protocol and communicated to the patient.

4 monitoring and assessments

Throughout the trial, the patient’s health will be monitored regularly to assess the effectiveness of the treatment.

Progression-free survival, overall survival, and response to treatment will be evaluated.

The patient will undergo regular health checks, including vital signs, ECG, and laboratory tests.

5 reporting symptoms

The patient will be asked to report any symptoms or side effects experienced during the trial.

Common symptoms to report include diarrhea, nausea, vomiting, and others as specified in the study protocol.

6 completion of the trial

The trial is expected to continue until September 2028.

Upon completion, the patient’s overall health and response to the treatment will be evaluated.

Who Can Join the Study?

  • The patient must have a type of lung cancer called KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
  • The cancer must be measurable according to a specific guideline called RECIST v1.1, which is a way to measure how the cancer responds to treatment.
  • The patient must have a confirmed presence of a KRAS G12C mutation, which is a specific change in the cancer cells, verified through a lab test.
  • The patient must have a test to check for a KEAP1 mutation, which is another specific change in the cancer cells, using a special lab test approved by the study sponsor.
  • The patient must provide a sample of their tumor, either in a block of tissue or as a set of slides, along with a report from a pathologist.
  • The patient must have a negative HIV test, meaning they do not have the HIV virus.
  • The patient must have a negative hepatitis B test, meaning they do not have the hepatitis B virus.
  • The patient must have a negative hepatitis C test, meaning they do not have the hepatitis C virus.
  • The patient must have adequate blood and organ function, which means their blood and organs are working well enough, as checked within 14 days before starting the study treatment.
  • The study is open to both male and female patients.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Centre Antoine Lacassagne Nice France
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
Laiko General Hospital Of Athens Athens Greece
Hospital Vall d’Hebron Barcelona Spain
Herlev Hospital Herlev Denmark
Uppsala University Hospital Uppsala Sweden
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Helsinki University Central Hospital Helsinki Finland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centro Hospitalar E Universitario De Coimbra E.P.E. Coimbra Portugal
Kliniken der Stadt Koeln gGmbH Cologne Germany
Universitaetsklinikum Muenster AöR Munster Germany
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Centre Leon Berard Lyon France
University Of Antwerp Edegem Belgium
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Universitaetsklinikum Essen AöR Essen Germany
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Centre hospitalier universitaire de Liege Liege Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Amphia Hospital Breda The Netherlands
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Centre Hospitalier Regional D’Angers Angers France
Algemeen Ziekenhuis Delta Roeselare Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Vitaz Sint-Niklaas Belgium
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Istituto Oncologico Veneto Padua Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Theageneio Cancer Hospital Thessaloniki Greece
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Palermo Italy
Universitaetsklinikum Regensburg AöR Regensburg Germany
Saarland University Hospital Homburg Germany
Aarhus University Hospital Aarhus Denmark
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Virgen De Valme Sevilla Spain
Medical Center Haaglanden Leidschendam The Netherlands
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Cracow Poland
Muenchen Klinik gGmbH Munich Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Pohjois-Savon hyvinvointialue Kuopio Finland
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Azienda Ospedaliero Universitaria Parma Parma Italy
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Rijnstate Ziekenhuis Stichting Arnhem The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
University Magna Graecia Of Catanzaro Catanzaro Italy
National Institute Of Tuberculosis And Lung Diseases Warsaw Poland
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii Wroclaw Poland
Henry Dunant Hospital Center Athens Greece
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung Essen Germany
Region Gaevleborg Gavle Sweden

Other Sites

Site Name City Country Status
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
CHU Bordeauxt Bordeaux France
Centre Hospitalier De Saint-Quentin Saint Quentin France
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Metropolitan Hospital Athens Greece
Aliccpvlg Kgfbeg Gmbsrfb Graq Gauting Germany
Oevdmejbgdqwcleykqrdmxmclk Aalst Belgium
Cvornw Hixcqiufbtv Uyvqmuabffvek Dmydim Gdjvosb Szjdvsjeljomiyzsyozzezchnc Namur Belgium
Kgwqqsqcsct Ndan Kpwnap Fmadtoxgggu Vienna Austria
Hhi Szhyjn Afil Toulon France
Kmncmqno Prtfpgeoy Cunyfmq Phrsityketfz W Bldzgbcuzw Shckc Bydgoszcz Poland
Rldmza Mcbtftxuaee Herning Denmark
Sqo Lcrclzmghdmq Hmrxexbo Svdj Thessaloniki Greece
Wuhsxqmwbezdd Ckbhjnk Pxywgpgrmfja I Tobqrntqsfqdipn Ign Etwltrn I Jrnonii Zwwuhrvsy Poznan Poland
Koowyzo Nqwacnnfqjpgzikcmug Sjk z ojkn Radom Poland
Jqjfkw Bptdu Zbapsddgcl Sbxsnurer S-Hertogenbosch The Netherlands
Egfsmhjsckon Lqeocibsvmkt Blhebv Kiyetlbseszwcxzvrho gbvhj Berlin Germany
Zznntvhrwf Sw Jlfbsra Harderwijk The Netherlands
Kfufxlope Syqgwit Saztizfxzqgwukj im Jdgy Pgruh Ir Cracow Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
12.09.2024
Belgium Belgium
Not recruiting
12.09.2024
Denmark Denmark
Not recruiting
12.09.2024
Finland Finland
Not recruiting
12.09.2024
France France
Not recruiting
12.09.2024
Germany Germany
Not recruiting
12.09.2024
Greece Greece
Not recruiting
12.09.2024
Italy Italy
Not recruiting
12.09.2024
Poland Poland
Not recruiting
12.09.2024
Portugal Portugal
Not recruiting
12.09.2024
Spain Spain
Not recruiting
12.09.2024
Sweden Sweden
Not recruiting
12.09.2024
The Netherlands The Netherlands
Not recruiting
12.09.2024

Trial locations

Divarasib is a medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer that has a specific genetic mutation known as KRAS G12C. This medication is being compared to other treatments to see if it can help patients live longer without their cancer getting worse.

Sotorasib is a medication used to treat non-small cell lung cancer with the KRAS G12C mutation. It works by targeting and inhibiting the activity of the mutated KRAS protein, which is involved in the growth and spread of cancer cells.

Adagrasib is another treatment option for non-small cell lung cancer with the KRAS G12C mutation. Like sotorasib, it targets the KRAS protein to help stop the cancer from growing and spreading. This study is comparing its effectiveness to divarasib.

KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer characterized by a specific genetic mutation in the KRAS gene, known as G12C. It primarily affects the cells lining the lungs and is classified as non-small cell, which is the most common type of lung cancer. The disease is considered advanced or metastatic when it has spread beyond the lungs to other parts of the body. As the cancer progresses, it can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The presence of the KRAS G12C mutation can influence the behavior of the cancer and its response to certain treatments. Understanding the mutation is crucial for developing targeted therapies aimed at slowing the progression of the disease.

Trial ID:
2024-510908-37-00
Protocol code:
BO45217
Trial Phase:
Therapeutic confirmatory (Phase III)

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