Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation
• Intervention / Treatment: Drug: Sotorasib; Drug: RMC-4630; Drug: TNO155; Drug: BI 1701963; Drug: Trametinib; Drug: Afatinib; Drug: Pembrolizumab; Drug: Palbociclib; Drug: Everolimus; Drug: Panitumumab; Drug: IV Chemotherapy (Regimen 1); Drug: Atezolizumab; Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel; Drug: MVASI® (bevacizumab-awwb); Drug: IV Chemotherapy (Regimen 2); Drug: AMG 404

• Study Type: Interventional
• Enrollment (Actual): 610
• Phase: Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Cancer Centre
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare -North Shore Oncology
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care South Brisbane
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Healthcare
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
• Belgium
  • Brussels, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • CHU de Quebec Hopital de l Enfant Jesus
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin, Campus Virchow
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
• Italy
  • Milan, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Verona, Italy, 37126
    • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Seoul, South Korea, 138-736
    • Asan Medical Center
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clínic i Provincial de Barcelona
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall d Hebron
    • L'Hospitalet de Llobregat, Catalonia, Spain, 08908
      • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Taiwan
  • Tainan City, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates Professional Corporation
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • La Jolla, California, United States, 92093
      • University Of California San Diego Moores Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Cancer Center
    • Los Angeles, California, United States, 90033
      • University of Southern California, Norris Comprehensive Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • San Francisco, California, United States, 94115
      • University of California San Francisco Mission Bay Campus
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers Denver Midtown
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • Florida
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5912
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
  • Missouri
    • St Louis, Missouri, United States, 63110-1093
      • Washington University
  • New York
    • Buffalo, New York, United States, 32224
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19111
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Gibbs Cancer Center and Research Institute - Spartanburg
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • United States Oncology Regulatory Affairs Corporate Office
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology Central-South
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Oncology Consultants
    • The Woodlands, Texas, United States, 77380
      • US Oncology Research Investigational Products Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology Northeast Texas
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Cancer Center
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center
    • Tacoma, Washington, United States, 98405
      • NorthWest Medical Specialties, PLLC
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists - Vancouver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

• Primary brain tumor.
• Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
• Myocardial infarction within 6 months of study day 1.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sotorasib + RMC-4630; Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: RMC-4630; RMC-4630 administered orally as a capsule.
Experimental: Sotorasib Monotherapy; Experimental: Sotorasib only Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.	Drug: Sotorasib; Sotorasib administered orally as a tablet.
Experimental: Sotorasib + palbociclib; Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Palbociclib; Palbociclib administered orally as a tablet.
Experimental: Sotorasib + trametinib + panitumumab; Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Trametinib; Trametinib administered orally as a tablet.; Drug: Panitumumab; Panitumumab administered as an IV infusion.
Experimental: Sotorasib + afatinib; Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Afatinib; afatinib administered orally as a tablet.
Experimental: Sotorasib + pembrolizumab; Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Pembrolizumab; pembrolizumab administered as an intravenous (IV) infusion.
Experimental: Sotorasib + atezolizumab; Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Atezolizumab; Atezolizumab administered as an IV injection.
Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab; Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Pembrolizumab; pembrolizumab administered as an intravenous (IV) infusion.; Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel; Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Experimental: Sotorasib + TNO155; Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: TNO155; TNO155 administered orally as a capsule.
Experimental: Sotorasib + BI 1701963; Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.; Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: BI 1701963; BI 1701963 administered orally
Experimental: Sotorasib + AMG 404; Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: AMG 404; AMG 404 administered as an IV infusion.
Experimental: Sotorasib + everolimus; Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Everolimus; Everolimus administered orally.
Experimental: Sotorasib + panitumumab +/- chemotherapy; Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: Panitumumab; Panitumumab administered as an IV infusion.; Drug: IV Chemotherapy (Regimen 1); Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.
Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy; Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion; Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.; Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.	Drug: Sotorasib; Sotorasib administered orally as a tablet.; Drug: IV Chemotherapy (Regimen 1); Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.; Drug: MVASI® (bevacizumab-awwb); MVASI® (bevacizumab-awwb) administered as an IV infusion.; Drug: IV Chemotherapy (Regimen 2); IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Dose Limiting Toxicities (DLTs)	12 Months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	12 Months
Number of Participants with Treatment-related Adverse Events	12 Months
Number of Participants with Clinically Significant Changes in Vital Signs	12 Months
Number of Participants with Clinically Significant Changes in ECG Measurements	12 Months
Number of Participants with Clinically Significant Changes in Laboratory Test Values	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		12 Months
Maximum Plasma Concentration (Cmax)		12 Months
Time to Maximum Plasma Concentration (Tmax)		12 Months
Area Under the Plasma Concentration-time Curve (AUC)		12 Months
Objective Response Rate		12 Months
Disease Control Rate		12 Months
Duration of Response		12 Months
Progression-free Survival		12 Months
Duration of Stable Disease		12 Months
Time to Response		12 Months
Sotorasib + EGFR Inhibitor +/- Chemotherapeutic Regimen Only: Quantification of Plasma Levels		12 Months
Sotorasib Monotherapy Only: Intracranial Objective Response Rate	Intracranial objective response rate assessed per Response Assessment in Neuro-oncology Brain Metastases (RANO-BM).	12 Months
Sotorasib Monotherapy Only: Intracranial Disease Control Rate	Intracranial disease control rate assessed per RANO-BM.	12 Months
Sotorasib Monotherapy Only: Intracranial Duration of Response	Intracranial duration of response assessed per RANO-BM.	12 Months
Sotorasib Monotherapy Only: Time to Intracranial Radiation Therapy		12 Months
Sotorasib Monotherapy Only: Intracranial Progression-free Survival (PFS)	Intracranial PFS assessed per RANO-BM.	12 Months
Sotorasib Monotherapy Only: Non-intracranial Progression-free Survival (PFS)	Non-intracranial PFS assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	12 Months
Sotorasib Monotherapy Only: Overall Progression-free Survival (PFS)	Overall PFS assessed per RECIST 1.1 and RANO-BM.	12 Months
Sotorasib + TNO155 Only: Best Overall Response		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Dose Limiting Toxicities (DLTs)		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-emergent Adverse Events (TEAEs)		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Treatment-related Adverse Events		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Vital Signs		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in ECG Measurements		12 Months
Sotorasib + Afatinib + Loperamide Only: Number of Participants with Clinically Significant Changes in Laboratory Test Values		12 Months

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): December 5, 2027

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms; Sarcoma; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Amides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Macrolides; Lactones; Sirolimus; Quinazolines; Docetaxel; Bevacizumab; Pemetrexed; Panitumumab; Everolimus; Afatinib; Carboplatin; Paclitaxel; trametinib; pembrolizumab; Drug Therapy; atezolizumab; palbociclib; sotorasib
• Other Study ID Numbers: 20190135; 2023-506794-35 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing 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 (or other new use) 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.
• IPD Sharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No