Comparing Sotorasib and Pembrolizumab with chemotherapy for patients with advanced non-small cell lung cancer and a KRAS G12C mutation

3 1 1 1

What is this study about?

This study focuses on individuals with Nonsquamous Non-Small Cell Lung Cancer, a type of lung cancer, specifically those at stage IV or advanced stage IIIB/C. The research is for patients whose tumors do not show high levels of PD-L1, a protein used to help the immune system find cancer, and instead have a specific genetic change known as a KRAS p.G12C mutation. The purpose of the study is to compare the effectiveness of two different treatment approaches used as a first-line therapy.

One group will receive sotorasib combined with a platinum doublet, which refers to a combination of two drugs like carboplatin and pemetrexed. The other group will receive pembrolizumab along with the same platinum doublet. Other medications, such as folic acid, hydroxocobalamin, dexamethasone, and antiemetics, may be used to support the treatment and manage side effects. During the study, the time until the cancer grows or worsens and the total length of time patients live are monitored.

Who Can Join the Study?

  • You must be a man or a woman who is 18 years of age or older.
  • You must have a confirmed diagnosis of nonsquamous non-small cell lung cancer, which is a specific type of lung cancer that does not start in the mucus-producing cells.
  • Your cancer must be at Stage IV or advanced Stage IIIB/C, meaning the cancer is at an advanced stage and has spread or is growing significantly.
  • Tests must show you have a specific genetic change called a KRAS p.G12C mutation, which is a change in the protein that helps cancer cells grow.
  • Tests must show that your cancer is negative for PD-L1, which means a specific protein used by cancer cells to hide from the immune system is not present in large amounts.
  • You must not have previously received systemic anticancer therapy, which refers to medicines like chemotherapy that travel through the entire body, to treat cancer that has spread or cannot be cured.
  • You must have an ECOG score of 1 or less, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health.

Who Cannot Join the Study?

  • You cannot participate if your lung cancer is a mixed histology type, which means the cancer cells are a mix of different types, or if it contains small-cell or large-cell neuroendocrine cells (specific types of fast-growing cancer cells), or if it is mostly squamous cell (a specific type of cancer cell found in the lining of organs).
  • You are excluded if your tumor has molecular alterations, which are specific changes or mutations in the cancer’s DNA, that can already be treated with a targeted therapy (a medicine designed to attack a specific part of a cancer cell) that is approved in your area.
  • You cannot join if you have brain metastases, which means the cancer has spread to the brain, and it is causing symptoms (physical signs of illness) whether it has been treated or not.
  • You are excluded if you have gastrointestinal (GI) tract disease, which is any illness affecting your digestive system (such as the stomach or intestines), that makes it impossible for you to swallow or take medicine by mouth.
  • You cannot participate if you have had a myocardial infarction, commonly known as a heart attack, within the last 6 months, or if you have unstable arrhythmias (irregular heartbeats that are not controlled) or unstable angina (chest pain caused by reduced blood flow to the heart that is changing or worsening).
  • You are excluded if you have previously received treatment using a KRAS G12C inhibitor, which is a specific type of drug designed to block a particular mutation in the cancer.

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
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire Rouen Rouen France
Hopital Tenon Paris France
Hospital Vall d’Hebron Barcelona Spain
Institutul Regional De Oncologie Iasi Iasi Romania
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hospital Universitario da A Coruna A Coruna Galicia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Intercommunal Creteil Creteil France
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Assistance Publique Hopitaux De Marseille Marseille France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Alexandra Hospital Athens Greece
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Medical University Of Graz Graz Austria
Stichting Radboud University Medical Center Nijmegen The Netherlands
Centre Hospitalier Regional Universitaire De Tours Tours France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier De La Cote Basque Bayonne France
General University Hospital Of Patras Patras Greece
Athens Medical Center S.A. Thessaloniki Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Sahlgrenska University Hospital-Vastra Gotalandsregionen Gothenburg Sweden
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands
Hospital De La Santa Creu I Sant Pau Barcelona Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Centre Hospitalier Universitaire De Nimes Nimes France
Institut Gustave Roussy Villejuif France
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Universitair Medisch Centrum Groningen Groningen The Netherlands
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Marques De Valdecilla Santander Spain
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Universita Degli Studi Di Brescia Brescia Italy
Servei De Salut De Les Illes Balears Palma Spain
Az Maria Middelares Gent Gent Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Clinico Universitario De Valladolid Valladolid Spain
Universitaetsklinikum Krems Krems An Der Donau Austria
Institut Curie – Site Paris Paris France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Pauls Stradins Clinical University Hospital Riga Latvia
Mbal Za Zhensko Zdrave Nadezhda OOD Sofia Bulgaria
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Med Polonia Sp. z o.o. Poznan Poland
Theageneio Cancer Hospital Thessaloniki Greece
Koranyi National Institute For Pulmonology Budapest Hungary
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Institut de Cancérologie Hématologie Universitaire de Saint Etienne (iCHUSE) Saint Priest En Jarez France
Centre Hospitalier Universitaire d’Orléans Orléans France
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Centre Hospitalier Le Mans Le Mans France
Besancon University Hospital Center Besançon France
Champalimaud Clinical Centre Lisbon Portugal
Hopital Ambroise Pare Boulogne-Billancourt France
Universitaetsmedizin Goettingen Goettingen Germany
Ludwig Maximilian University Of Munich Munich Germany
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Gyor Hungary
Centre Hospitalier Metropole Savoie Chambery France
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Hopital Saint Joseph Marseille France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Cracow Poland
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
University Hospital Olomouc Olomouc Czechia
Azienda Ospedaliero Universitaria Parma Parma Italy
Centre Hospitalier Universitaire Reims Reims France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Region Vaesterbotten Umea Sweden
Isala Klinieken Stichting Zwolle The Netherlands
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Santa Maria Della Misericordia Perugia Italy
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Emmaues Mechelen Belgium
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemysl Poland
Region Gaevleborg Gavle Sweden

Other Sites

Site Name City Country Status
Clinique Pasteur Toulouse France
Hospital Da Luz S.A. Lisbon Portugal
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Cracow Poland
Klinikum Wels-Grieskirchen GmbH Wels Austria
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
L’Hopital Prive Du Confluent Nantes France
Medisprof S.R.L. Cluj Napoca Romania
Centre De Cancerologue Du Grand Montpellier Montpellier France
Spitalul Municipal Ploiesti Ploiesti Romania
Stichting Meander Medisch Centrum Amersfoort The Netherlands
Umhat Sveta Marina – Pleven OOD Pleven Bulgaria
Athens Medical Center S.A. Athens Greece
Bzpdnrjjr Uvladb Unooz Keegcw Budapest Hungary
Hulxwkq Pakeadxewlqulird Rllhdf Rennes France
Kroboqyo Cupunuee gnqvh Chemnitz Germany
Ajhtkkshm Kxthda Gjmsztg Gvzl Gauting Germany
Sgjvzrab Pixddaxce Sps z oviy Gdynia Poland
Hnqinrmw Ctk Potqg Sekz Porto Portugal
Cpxopu Hkljxlciotk Ibvltdlawflmp Dk Csddmcdwvul Quimper France
Mnpdms Ceghft Cfzhqo Hbcneyuk Od Pzfugbs Piraeus Greece
Fdrehiitayxf Tnqtodlpcgsnzssr Farkasgyepu Hungary
Maldvj Gxznvvlmlggl Gyongyos Hungary
Cp Vqbqhdaqztgy Ntvo Oczqk Villefranche sur Saône France
Mqzduvqgcmee Hllwrdra Athens Greece
Bkksyevgppotofcy Kbchcwrbyceujiww Gdum Eisenstadt Austria
Keawgbbgpkzps Axqrqa gltlv Immenstadt im Allgäu Germany
Fpjpqztz Nfzofzwca Pcigj Plzen Czechia
Dqucyydll Cwcwbcfv Dn Smthwyt Dd Skzus Dqc Ajitha Toulon France
Lkh Hfgygbys Uktugnibvgdsdd Dr Sbyzyskwve STRASBOURG, Alsace France
Sxi Egwpiuipv Htfenpwt Tlsjwta Tilburg The Netherlands
Rmnji Ahiixzgj ksjcurot uncdvbhrspxfh sesqnbwu Sfh Riga Latvia
Otvcbnl Sylcys Timisoara Romania
Rchzro Mwjoxzcynqm Herning Denmark
Hihhxmko Cmw Trsg Snkq Lisbon Portugal
2gv Abg Fduhv Ginstwq Hhthibgd Athens Greece
Czdzyp Brussels Belgium
Hnnitlip Usbapzwwcpzqf Dw Bnvrpcd Badajoz Spain
Jpqtssuojyncbvtatesq Viwliozst Hapvsee Gedh Kyvsaqgvojygsuxcxhuni Szolnok Hungary
Cgibgi Huqjnrhkgdb Pdtfx Sgraqjyixhkymn Saint-Gregoire France
Zwdaxwflev Sl Jbvxacy Harderwijk The Netherlands
Ubsdyoy Llxbo Dj Sklaf Db Mhuiknzuhc Eyoteq Senhora Da Hora Portugal
Mxkonvsbeqvq Hpveehpd Flo Aambdy Thkdeodissdqk Hshhgllz Lrru Panagyurishte Bulgaria
Cvgvaqt Pqojiueixkyn I Tqxwulcmqulzxlr W Byuxgfb Wilkowice Poland
Gwm Gmhpms hsqqdfmafkw Pnkms Svaurwjfzbww Paris 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
01.11.2023
Belgium Belgium
Recruiting
01.11.2023
Bulgaria Bulgaria
Recruiting
01.11.2023
Czechia Czechia
Recruiting
01.11.2023
Denmark Denmark
Recruiting
01.11.2023
France France
Recruiting
01.11.2023
Germany Germany
Recruiting
01.11.2023
Greece Greece
Recruiting
01.11.2023
Hungary Hungary
Recruiting
01.11.2023
Italy Italy
Recruiting
01.11.2023
Latvia Latvia
Not recruiting
01.11.2023
Poland Poland
Recruiting
01.11.2023
Portugal Portugal
Recruiting
01.11.2023
Romania Romania
Recruiting
01.11.2023
Spain Spain
Recruiting
01.11.2023
Sweden Sweden
Recruiting
01.11.2023
The Netherlands The Netherlands
Recruiting
01.11.2023

Trial locations

Sotorasib is the main experimental treatment being tested in this study. It is a pill taken by mouth and is being studied to see how well it works when combined with chemotherapy to treat certain types of advanced lung cancer.

Pembrolizumab is a medication used as a comparison in this study. It is given through an IV (into a vein) and is part of a treatment plan used to compare against the experimental therapy to see which is more effective for patients with this specific type of lung cancer.

Non-small cell lung cancer – This is a type of lung cancer that starts in the cells lining the inside of the lungs. It is the most common form of lung cancer and can involve different types of cells. The disease progresses as abnormal cells grow and multiply uncontrollably within the lung tissue. Over time, these cells may spread to nearby tissues or other parts of the body. In advanced stages, the cancer can involve several regions or distant organs.

Trial ID:
2022-501863-41-00
Protocol code:
20190341
NCT ID:
NCT05920356
Trial Phase:
Therapeutic confirmatory (Phase III)

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