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Study of Adagrasib and Cetuximab for Patients with Advanced Colorectal Cancer with KRAS G12C Mutation After First-Line Therapy

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What is this study about?

This clinical trial is focused on studying a type of cancer known as Advanced Colorectal Cancer that has a specific genetic change called the KRAS G12C Mutation. The trial is testing a new treatment approach using a combination of two medications: Adagrasib (also known by its code name MRTX849) and Cetuximab. These medications will be compared to standard chemotherapy treatments, which include combinations like FOLFIRI or mFOLFOX6. The purpose of the study is to see how effective the new combination is in treating patients whose cancer has progressed after receiving initial standard treatments.

Participants in the study will receive either the new combination of Adagrasib and Cetuximab or one of the standard chemotherapy treatments. The study will monitor how long patients live and how long they remain free from cancer progression. It will also look at other factors such as side effects, how well the cancer responds to treatment, and the quality of life of the participants. The study will last for a period of time, with regular check-ups and assessments to track the progress and effects of the treatments.

This trial is important for understanding if the new treatment combination can offer better outcomes for patients with Advanced Colorectal Cancer with the KRAS G12C Mutation. The results could potentially lead to new treatment options for this specific type of cancer, providing hope for improved management of the disease. Participants will be closely monitored throughout the study to ensure their safety and to gather valuable data on the effectiveness of the treatments being tested.

1 joining the study

Upon joining the study, participation is confirmed for individuals with a diagnosis of advanced colorectal cancer with a specific genetic mutation known as KRAS G12C.

Eligibility requires prior treatment with a specific type of chemotherapy and documented disease progression.

2 randomization

Participants are randomly assigned to one of two groups: one receiving a combination of adagrasib and cetuximab, and the other receiving standard chemotherapy.

3 treatment administration

For those in the adagrasib and cetuximab group, adagrasib is taken orally, while cetuximab is administered intravenously as a solution for infusion.

Participants in the chemotherapy group receive either the FOLFIRI or mFOLFOX6 regimen, which includes drugs such as fluorouracil, oxaliplatin, calcium folinate, and irinotecan, all given intravenously.

4 monitoring and assessments

Regular monitoring is conducted to assess overall survival and progression-free survival.

Secondary assessments include tracking any adverse events, measuring the response rate to treatment, and evaluating the duration of response.

5 quality of life evaluation

Participants complete assessments to report outcomes related to their quality of life throughout the study.

6 study completion

The study is estimated to conclude by May 25, 2025, with final evaluations conducted to determine the effectiveness of the treatments.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of colorectal cancer with a specific change in the KRAS gene, known as the G12C mutation. This means that the cancer cells have a particular genetic alteration.
  • The patient must have already received a first round of treatment for advanced colorectal cancer. This treatment should have included a type of chemotherapy that uses a drug called fluoropyrimidine, combined with either oxaliplatin or irinotecan. These are medications used to treat cancer.
  • The patient’s cancer must have shown signs of getting worse, as seen in medical imaging tests, either during or after the first round of treatment.
  • Both male and female patients are eligible to participate in the study.
  • The study is open to adults, which typically means individuals who are 18 years or older.

Who Cannot Join the Study?

  • Patients who do not have advanced colorectal cancer with a specific genetic change called KRAS G12C mutation cannot participate.
  • Patients who are not in the age range specified for the study cannot participate.
  • Patients who are not able to receive the treatments being tested in the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Hopital Saint Antoine Paris France
General University Hospital Of Larissa Larissa Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Alexandra Hospital Athens Greece
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Champalimaud Clinical Centre Lisbon Portugal
Turku University Hospital Turku Finland
Hospital General Universitario De Valencia Valencia Spain
Muenchen Klinik gGmbH Munich Germany
Rigshospitalet Copenhagen Denmark
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Kliniken Maria Hilf GmbH Moenchengladbach Moenchengladbach Germany
St. Josef-Hospital Bochum Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Klinikum St Marien Amberg Amberg Germany
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare Baia Mare Romania
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
AORN San Giuseppe Moscati Avellino Avellino Italy
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Netherlands Cancer Institute Amsterdam The Netherlands
Vrije Universiteit Brussel Jette Belgium
Odense University Hospital Odense Denmark
Stichting Radboud University Medical Center Nijmegen The Netherlands
St Vincent’s University Hospital Dublin Ireland
Pirkanmaan hyvinvointialue Tampere Finland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Institut fuer Klinische Krebsforschung IKF GmbH Frankfurt Germany
Fundeni Clinical Institute Bucharest Romania
Kcwilzzfksran Rrciomwlxf Gdds Reutlingen Germany
Nhy Lwb Gtesvxrdzv Tnavrxqkgbbfj Gcfw Wiener Neustadt Austria
Agqktlvhv Uqr Amsterdam The Netherlands
Bzuadink Ubdjontwtu Hftffgjd Czcbwb Besançon France
Cumiis Hrqzxnutlch Rtdarpye Uhdgcanltidol Ds Tspoo Tours France
Ulp Mynfmwncknxo Yvoir Belgium
Ptexnuvyw Iypjmgjm Mjnchegf Mhhvjkvgjpqu Sblud Wiywsuadydzg I Avyycbtoywzuc Warsaw Poland
Kkhxvbnw dwj Umdsmxytdjxw Mmtpxjqg Amy Munich Germany
Azvcxwv Uzl Iroyu Dl Rmtcok Eoriie Reggio Emilia Italy
Ipswkl Ilxjxltq Fowgepzckzhue Ohtilwsnojx Rome Italy
Hpgzgigw Umkuawgpxdjqt Mpyvife Dq Vazgalbhqe Santander Spain
Ixhzcivs Cmcvss Dlepgbjyyafqeznzx L'hospitalet De Llobregat Spain
Ujdieeydyd Huapaiunh Pqvdl Sfklohgxtwh Ckkxxpr Fnbx Paris France
Mqxvme Hlxglqni Hpjhs Uqfjfnjddwypaucebrzp dhl Rflkiguiylasoybq Bcjodl Herne Germany
Frprhbvl nrxkgdpvh Mubvj a Hsjsdnx Prague Czechia
Fickonxvi Pdlg Lb Ikfixwubmrikn Bawtbhhyd Dtz Hglkuvva Uhgqhmjkxtzal Li Pdi Madrid Spain
Nhshqbfu Ihlbmsmq Occducdqq Idk Miywd Sorsqxwcwkxmwtebekitynlhgpdz Inlpcwrd Bayhqvjz Cracow Poland
Hzyvknjx Vsda dlaofwzo Barcelona Spain
Afhh &uoqjpv Hkwjzax Dg Lm Txdbmi &mlrmcj Deouucjzpzxrj Vbpjkidzlebv Em 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
Not recruiting
15.03.2021
Belgium Belgium
Not recruiting
15.03.2021
Czechia Czechia
Not recruiting
15.03.2021
Denmark Denmark
Not recruiting
15.03.2021
Finland Finland
Not recruiting
15.03.2021
France France
Not recruiting
15.03.2021
Germany Germany
Not recruiting
15.03.2021
Greece Greece
Not recruiting
15.03.2021
Ireland Ireland
Not recruiting
15.03.2021
Italy Italy
Not recruiting
15.03.2021
Poland Poland
Not recruiting
15.03.2021
Portugal Portugal
Not recruiting
15.03.2021
Romania Romania
Not recruiting
15.03.2021
Spain Spain
Not recruiting
15.03.2021
The Netherlands The Netherlands
Not recruiting
15.03.2021

Trial locations

Investigated drugs:

Adagrasib is a medication being studied for its potential to treat advanced colorectal cancer. It is specifically designed to target and inhibit the KRAS G12C mutation, which is a common mutation found in some cancer cells. By blocking this mutation, adagrasib aims to stop the growth and spread of cancer cells.

Cetuximab is a type of therapy known as a monoclonal antibody. It works by targeting a specific protein on the surface of cancer cells, known as the epidermal growth factor receptor (EGFR). By binding to this protein, cetuximab can help slow down or stop the growth of cancer cells.

FOLFIRI is a combination chemotherapy regimen used to treat colorectal cancer. It includes three different drugs: folinic acid, fluorouracil, and irinotecan. These drugs work together to kill cancer cells or stop them from dividing and growing.

mFOLFOX6 is another combination chemotherapy regimen used in the treatment of colorectal cancer. It consists of folinic acid, fluorouracil, and oxaliplatin. This combination works by damaging the DNA of cancer cells, which prevents them from growing and dividing.

Investigated diseases:

Advanced Colorectal Cancer with KRAS G12C Mutation – This is a type of colorectal cancer characterized by a specific genetic mutation known as KRAS G12C. Colorectal cancer originates in the colon or rectum, which are parts of the large intestine. The KRAS G12C mutation affects the KRAS gene, which plays a role in cell division and growth. This mutation can lead to uncontrolled cell growth, contributing to cancer progression. Advanced colorectal cancer indicates that the disease has spread beyond the initial site to other parts of the body. The progression of this cancer can vary, but it typically involves the growth and spread of cancerous cells, potentially affecting various organs and systems.

Trial ID:
2023-506241-30-00
Protocol code:
849-010
NCT ID:
NCT04793958
Trial Phase:
Therapeutic confirmatory (Phase III)

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