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

Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Hospital General Universitario De Valencia	Valencia	Spain
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Fundeni Clinical Institute	Bucharest	Romania
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Hopital Beaujon	Clichy	France
Gewvvcd Uwrpmmpczn Huljzojr Oi Ljlmxkf	Larissa	Greece
Hjmefjss Vokn dqstpycw	Barcelona	Spain
Fhhxpefj nwtwzdpfa Mgdln a Hvxxxxg	Prague	Czechia
Odzpdt Uwuelvmxlb Hxafyjez	Odense	Denmark
Ajmnuuxxg Ulr	Amsterdam	The Netherlands
Aspzxxlcg Hrvhiosr	Athens	Greece
Hpcxsjbk Cunqgh Dr Bdzxfhwvm	Barcelona	Spain
Cpmerrw Unjrxoqenafebsphjdia Bnpcnq Kyz	Berlin	Germany
Cptbrk Hjnipqllufz Rfmmcywe Unpzshjhiswjz Dj Tiagq	Tours	France
Hswjbseq Clsqmlg Sbf Cugcpf	Madrid	Spain
Kjzgeayk dro Utyzqxfaknmr Maowdvwy Ahw	Munich	Germany
Rajtqksstuufjw	Copenhagen	Denmark
Iynofu Ihqwjvzd Fyqugchgheyho Opjnypvsdfp	Rome	Italy
Hhwoalvi Uhmrnwqrowcgd 1k Dq Orihxit	Madrid	Spain
Htqlnqnx Uftgvbbpivtha Mmxgfoe Di Vldxxgkccy	Santander	Spain
Vocqo Uhayfatlwqnw Bmvsjpj	Jette	Belgium
Itinwxso Ctfzhf Dchropmcwanygagwb	L'hospitalet De Llobregat	Spain
Fxsgjzium Pbtx Ls Icdalyibumnht Bdgoolwwl Dur Hdhklrio Utollmjimcmzs Ll Phj	Madrid	Spain
Kigjhpgj Sl Mobnxd Anlwqh	Amberg	Germany
Azmjeiw Oxeaxtpvaba Udnazlgeisdyv Pacjqm	Pisa	Italy
Inmqkjua Oxaigxlrbv Vntoxk	Padua	Italy
Hsbphgh Shuhh Accyisu	Paris	France
Crtgkzn Dx Olenfkmgw Sz Nwaanfww Sxfqdf	Craiova	Romania
Mvobxq Hexadwnh Hkubg Ublsrtwuijqbjczorziv dxp Rfsjasvvdbrafqqq Bcwxjs	Herne	Germany
Kqqpmzastuler Rrcirptrbo Gisn	Reutlingen	Germany
Nfy Ltb Gckwbuuyts Topczxlsxyfny Gfwj	Wiener Neustadt	Austria
Azaq &ytzumm Hfkyyoq Dc Ld Tnglhd &jcyscv Dpxgisbbrwqvt Vqnokapcclrn Em	Marseille	France
Izhwwsax Du Crtuywfl Fsmoolgqpl Dma Pyybxmcf Pko Lfgorirwnw Itxui	Candiolo	Italy
Buapdyxb Uqzpwoexkn Hyigmgwm Cryrho	Besançon	France
Cgiycklvkrsh Cmhzfwfo Cjubeb	Lisbon	Portugal
Ujs Mfitwrdpaksx	Yvoir	Belgium
Ptfdmywug Iquhfxdh Myuwjhtq Mbivztscjzdh Smmxp Wcktdppftnfu I Amkyohkygciff	Warsaw	Poland
Mbgbjsba Kcvifn gkicw	Munich	Germany
Si Vxazgogllyoxvuc Ucowabajul Hjgphroi	Dublin	Ireland
Agcweaf Ukf Iafff Ds Rpearo Eltusj	Reggio Emilia	Italy
Auufhdb Sxrjgvaes Lxgmlm Dcufz Pvgpyggol Dm Bjhlyf	Ponderano	Italy
Ngjkdvyasdw Coajvr Icnezwieu	Amsterdam	The Netherlands
Hmpzlhql Fksc	Suresnes	France
Keovpsdo Mlynk Hknt Gdyj Mbxakupgpimurmjx	Moenchengladbach	Germany
She Jittvekotceybl	Bochum	Germany
Uhamebweiq Higljpbks Payyt Sylmjfobjzi Cqrshxg Focg	Paris	France
Euwufhjnse Gjlwljo Cnitsv Ox Tlvvytighhdl	Thessaloniki	Greece
Swoplfbl Jkommhks Dv Ujqquqy Ddn Cnadkeomdl Oygtj Bkov Mrfs	Baia Mare	Romania
Angb Sgq Gxhosrzv Mvvponc Ajlkdhaj	Avellino	Italy
Afnpctq Oupzxvftkea Upjwwcsopxcvm Ds Ctdccvvg	Monserrato	Italy
Ibitelcp fpfp Kqfarkjhk Kewwzvsnupusms Isf Gyyb	Frankfurt	Germany
Styxjmbrt Rxzcnfo Ucgomibggh Muxgxgc Cwmltx	Nijmegen	The Netherlands
Nhcudsin Iyjzzjhs Olyyiuktx Ibd Mrumw Sgcjxukngfhpkxgmzejaolsduayv Inknrsph Bqzrvafa	Cracow	Poland
Pcghztmsyd hdzsyzfhmmpoybv	Tampere	Finland
Iybrcehz fpfe Kfqqnitnf Tsqtrldehcyhtemmlil usu Ijwdnkjtitbk Uvn gnhib	Ulm	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.03.2021
Belgium	Not recruiting	15.03.2021
Czechia	Not recruiting	15.03.2021
Denmark	Not recruiting	15.03.2021
Finland	Not recruiting	15.03.2021
France	Not recruiting	15.03.2021
Germany	Not recruiting	15.03.2021
Greece	Not recruiting	15.03.2021
Ireland	Not recruiting	15.03.2021
Italy	Not recruiting	15.03.2021
Poland	Not recruiting	15.03.2021
Portugal	Not recruiting	15.03.2021
Romania	Not recruiting	15.03.2021
Spain	Not recruiting	15.03.2021
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.

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?