A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
1 other identifier
interventional
713
15 countries
129
Brief Summary
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2018
Longer than P75 for phase_1
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2026
CompletedJune 30, 2026
June 1, 2026
7.8 years
June 26, 2018
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (15)
Primary: Number of subjects with treatment-emergent adverse events
Treatment-emergent adverse events will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC * Phase 2 monotherapy dose comparison
24 Months
Primary: Number of subjects with treatment-related adverse events
Treatment-related adverse events will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC
24 Months
Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
Grade ≥3 treatment-emergent adverse events will be a primary outcome measure in the following group: \- Phase 2 monotherapy dose comparison
24 Months
Primary: Number of subjects with serious adverse events
Serious adverse events will be a primary outcome measure in the following group: \- Phase 2 monotherapy dose comparison
24 Months
Primary: Number of subjects with adverse events of interest
Adverse events of interest will be a primary outcome measure in the following group: \- Phase 2 monotherapy dose comparison
24 Months
Primary: Number of subjects with clinically significant changes in vital signs
Vital signs will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC
Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in physical examination results
Physical examinations will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1
Baseline to 24 Months
Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
ECGs will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC
Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in clinical laboratory values
Abnormal clinical laboratory values will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC
Baseline to 24 Months
Primary: Number of subjects with dose-limiting toxicities (DLTs)
DLTs will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC
21 Days
Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
ORR will be a primary outcome measure in the following group: * Phase 1 monotherapy treatment naïve advanced NSCLC * Phase 2 monotherapy * Phase 2 monotherapy dose comparison
24 Months
Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
DOR will be a primary outcome measure in the following group: \- Phase 1 monotherapy treatment naïve advanced NSCLC
24 Months
Primary: Disease control as assessed by RECIST 1.1 criteria
Disease control will be a primary outcome measure in the following group: \- Phase 1 monotherapy treatment naïve advanced NSCLC
24 Months
Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
Duration of SD will be a primary outcome measure in the following group: \- Phase 1 monotherapy treatment naïve advanced NSCLC
24 Months
Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
TTR will be a primary outcome measure in the following group: \- Phase 1 monotherapy treatment naïve advanced NSCLC
24 Months
Secondary Outcomes (30)
Secondary: Plasma concentration (Cmax) of sotorasib
15 Weeks
Secondary: Plasma concentration (Cmax) of midazolam
16 Days
Secondary: Time to achieve Cmax (Tmax) of sotorasib
15 Weeks
Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib
15 Weeks
Secondary: Area under the plasma concentration-time curve (AUC) of midazolam
16 Days
- +25 more secondary outcomes
Study Arms (6)
Phase 1 Dose Exploration Part 1 monotherapy
EXPERIMENTALCohorts with food effect and alternative dosing regimens Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
Phase 1 Dose Expansion Part 2 monotherapy
EXPERIMENTALUpon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 3 groups may be done concurrently
Phase 1 combination arm with sotorasib and anti PD-1/L1
EXPERIMENTALAdditional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1)
Phase 1 monotherapy treatment naive advanced NSCLC
EXPERIMENTALSeparate cohort of part 1 dose expansion subjects to evaluate the safety and clinical activity of sotorasib administered orally once daily in subjects with previously untreated advanced non-small cell lung cancer (NSCLC). Drug-drug interaction will be evaluated in 6 of the subjects enrolled in the treatment naive cohort by adding Midazolam alone on Day -1 and in combination with sotorasib on Day 15 of Cycle 1, where each cycle is 21 days.
Phase 2 monotherapy dose comparison
EXPERIMENTALSubjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy
Phase 1 Does escalation and Expansion monotherapy BID
EXPERIMENTALBID 2L+solid tumors (fed state)
Interventions
Administered as an intravenous (IV) infusion
Administered as an oral hydrochloride (HCI) syrup
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Eligibility Criteria
You may qualify if:
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
You may not qualify if:
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (133)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California at SF
San Francisco, California, 94115, United States
Sarcoma Oncology Research Center LLC
Santa Monica, California, 90403, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
University of Florida Health
Gainesville, Florida, 32610, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Washington University
St Louis, Missouri, 63110-1093, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center, Morris Cancer Clinic
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania, 15232, United States
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, 29303, United States
Vanderbilt University Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Texas Oncology - Austin Central
Austin, Texas, 78731, United States
Texas Oncology - Baylor
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
US Oncology Research Investigational Products Center
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists PC
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Peter MacCallum Cancer Centre
Parkville, Victoria, 3050, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Universitaetsklinikum Krems
Krems, 3500, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210, Austria
Institut Jules Bordet
Brussels, B-1070, Belgium
Grand Hopital de Charleroi
Charleroi, 6000, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, São Paulo, 01308-050, Brazil
Oncologia Rede D´Or
São Paulo, São Paulo, 04501-000, Brazil
Instituto Coi
Rio de Janeiro, 20231-050, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, H4A 3J1, Canada
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Hopital de la Timone
Marseille, 13385, France
Institut Curie
Paris, 75005, France
Institut Claudius Regaud
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Universitatsklinikum Koln
Cologne, 50937, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum der Universität München Campus Grosshadern
München, 81377, Germany
Henry Dunant Hospital Center
Athens, 11526, Greece
Metropolitan Hospital
Athens, 18547, Greece
University Hospital of Heraklion
Heraklion - Crete, 71500, Greece
Theagenion Cancer Hospital
Thessaloniki, 54007, Greece
Agios Loukas Clinic
Thessaloniki, 55236, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest, 1121, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Hospital Cuf porto
Porto, 4100-180, Portugal
Institutul Oncologic, Prof Dr Alexandru Trestioreanu
Bucharest, 022328, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
SC Medisprof SRL
Cluj-Napoca, 400641, Romania
Centrul de Radioterapie Amethyst Cluj
Cluj-Napoca, 407280, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200347, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28009, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Universitaetsspital Basel
Basel, 4031, Switzerland
Hopitaux Universitaires de Geneve
Geneva, 1211, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
Related Publications (12)
Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
PMID: 31666701BACKGROUNDSkoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4.
PMID: 34096690BACKGROUNDFakih MG, Kopetz S, Kuboki Y, Kim TW, Munster PN, Krauss JC, Falchook GS, Han SW, Heinemann V, Muro K, Strickler JH, Hong DS, Denlinger CS, Girotto G, Lee MA, Henary H, Tran Q, Park JK, Ngarmchamnanrith G, Prenen H, Price TJ. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):115-124. doi: 10.1016/S1470-2045(21)00605-7. Epub 2021 Dec 15.
PMID: 34919824BACKGROUNDHong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20.
PMID: 32955176BACKGROUNDZhao Y, Murciano-Goroff YR, Xue JY, Ang A, Lucas J, Mai TT, Da Cruz Paula AF, Saiki AY, Mohn D, Achanta P, Sisk AE, Arora KS, Roy RS, Kim D, Li C, Lim LP, Li M, Bahr A, Loomis BR, de Stanchina E, Reis-Filho JS, Weigelt B, Berger M, Riely G, Arbour KC, Lipford JR, Li BT, Lito P. Diverse alterations associated with resistance to KRAS(G12C) inhibition. Nature. 2021 Nov;599(7886):679-683. doi: 10.1038/s41586-021-04065-2. Epub 2021 Nov 10.
PMID: 34759319BACKGROUNDDy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-Term Outcomes and Molecular Correlates of Sotorasib Efficacy in Patients With Pretreated KRAS G12C-Mutated Non-Small-Cell Lung Cancer: 2-Year Analysis of CodeBreaK 100. J Clin Oncol. 2023 Jun 20;41(18):3311-3317. doi: 10.1200/JCO.22.02524. Epub 2023 Apr 25.
PMID: 37098232BACKGROUNDDy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-term benefit of sotorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: plain language summary. Future Oncol. 2024 Jan;20(3):113-120. doi: 10.2217/fon-2023-0560. Epub 2023 Nov 27.
PMID: 38010044BACKGROUNDDilly J, Hoffman MT, Abbassi L, Li Z, Paradiso F, Parent BD, Hennessey CJ, Jordan AC, Morgado M, Dasgupta S, Uribe GA, Yang A, Kapner KS, Hambitzer FP, Qiang L, Feng H, Geisberg J, Wang J, Evans KE, Lyu H, Schalck A, Feng N, Lopez AM, Bristow CA, Kim MP, Rajapakshe KI, Bahrambeigi V, Roth JA, Garg K, Guerrero PA, Stanger BZ, Cristea S, Lowe SW, Baslan T, Van Allen EM, Mancias JD, Chan E, Anderson A, Katlinskaya YV, Shalek AK, Hong DS, Pant S, Hallin J, Anderes K, Olson P, Heffernan TP, Chugh S, Christensen JG, Maitra A, Wolpin BM, Raghavan S, Nowak JA, Winter PS, Dougan SK, Aguirre AJ. Mechanisms of Resistance to Oncogenic KRAS Inhibition in Pancreatic Cancer. Cancer Discov. 2024 Nov 1;14(11):2135-2161. doi: 10.1158/2159-8290.CD-24-0177.
PMID: 38975874BACKGROUNDHochmair MJ, Vermaelen K, Mountzios G, Carcereny E, Dooms C, Lee SH, Morocz E, Kato T, Ciuleanu TE, Dy GK, Parente B, O'Byrne KJ, Chu QS, Castro Junior G, Girard N, Snyder W, Tran Q, Kormany W, Houk B, Mehta B, Curioni-Fontecedro A. Sotorasib (960 mg or 240 mg) once daily in patients with previously treated KRAS G12C-mutated advanced NSCLC. Eur J Cancer. 2024 Sep;208:114204. doi: 10.1016/j.ejca.2024.114204. Epub 2024 Jul 5.
PMID: 39029295BACKGROUNDNagase M, Houk B, Vuu I, Cardona P, Dutta S, Lin CW. Population Pharmacokinetics of Sotorasib in Healthy Subjects and Advanced Solid Tumor Patients Harboring a KRASG12C Mutation from Phase 1 and Phase 2 Studies. AAPS J. 2025 Jan 13;27(1):26. doi: 10.1208/s12248-024-01013-6.
PMID: 39806205BACKGROUNDStrickler JH, Satake H, George TJ, Yaeger R, Hollebecque A, Garrido-Laguna I, Schuler M, Burns TF, Coveler AL, Falchook GS, Vincent M, Sunakawa Y, Dahan L, Bajor D, Rha SY, Lemech C, Juric D, Rehn M, Ngarmchamnanrith G, Jafarinasabian P, Tran Q, Hong DS. Sotorasib in KRAS p.G12C-Mutated Advanced Pancreatic Cancer. N Engl J Med. 2023 Jan 5;388(1):33-43. doi: 10.1056/NEJMoa2208470. Epub 2022 Dec 21.
PMID: 36546651DERIVEDLanman BA, Allen JR, Allen JG, Amegadzie AK, Ashton KS, Booker SK, Chen JJ, Chen N, Frohn MJ, Goodman G, Kopecky DJ, Liu L, Lopez P, Low JD, Ma V, Minatti AE, Nguyen TT, Nishimura N, Pickrell AJ, Reed AB, Shin Y, Siegmund AC, Tamayo NA, Tegley CM, Walton MC, Wang HL, Wurz RP, Xue M, Yang KC, Achanta P, Bartberger MD, Canon J, Hollis LS, McCarter JD, Mohr C, Rex K, Saiki AY, San Miguel T, Volak LP, Wang KH, Whittington DA, Zech SG, Lipford JR, Cee VJ. Discovery of a Covalent Inhibitor of KRASG12C (AMG 510) for the Treatment of Solid Tumors. J Med Chem. 2020 Jan 9;63(1):52-65. doi: 10.1021/acs.jmedchem.9b01180. Epub 2019 Dec 24.
PMID: 31820981DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 26, 2018
Study Start
August 27, 2018
Primary Completion
May 29, 2026
Study Completion
May 29, 2026
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request