Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

May 12, 2026 updated by: National Cancer Institute (NCI)

A Randomized Phase II Study of AMG 510 (Sotorasib) With or Without Panitumumab in Advanced Solid Tumors: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab as compared to AMG 510 (sotorasib) alone in patients with advanced/metastatic KRAS G12C mutated solid tumors (except colorectal carcinoma [CRC] and non-small cell lung carcinoma [NSCLC]) as measured by progression free survival (Cohort 1).

II. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab in patients with advanced/metastatic KRAS G12C mutated solid tumors that have progressed on a prior KRAS G12C inhibitor as measured by response rate (Cohort 2).

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab as compared to AMG 510 alone in patients with advanced/metastatic KRAS G12C mutated solid tumors (except CRC and NSCLC) as measured by response rate, disease control rate, and overall survival (Cohort 1).

II, To evaluate the efficacy of the combination of AMG 510 (sotorasib) and panitumumab in patients with advanced/metastatic KRAS G12C mutated solid tumors that have progressed on a prior KRAS G12C inhibitor as measured by disease control rate, progression free survival (PFS), and overall survival (Cohort 2).

III. To further evaluate the safety and tolerability of the combination of AMG 510 (sotorasib) and panitumumab.

IV. To collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor-derived deoxyribonucleic acid (DNA) (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol.

CORRELATIVE EXPLORATORY OBJECTIVES:

I. To investigate the impact of concomitant mutations on the clinical benefit. II. To evaluate if changes in circulating tumor DNA (ctDNA) over time correlate with response to treatment.

III. To evaluate the relative mutant allele fraction of KRAS mutation as a predictor of clinical benefit.

IV. To evaluate if ERK 1/2 and PI3K pathway activation correlate with response and/or resistance.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: Patients who have never received a KRAS G12C inhibitor are randomized to arms A or B.

ARM A: Patients receive sotorasib orally (PO) once daily (QD) on days 1-28 and panitumumab intravenously (IV) on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and computed tomography (CT) or magnetic resonance imaging (MRI) on study.

ARM B: Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.

COHORT II: Patients who have received a KRAS G12C inhibitor are assigned to arm C.

ARM C: Patients receive combination therapy as in Arm A.

After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 36 months.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Mobile, Alabama, United States, 36688
    - University of South Alabama Mitchell Cancer Institute
- California
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90025
    - The Angeles Clinic and Research Institute - West Los Angeles Office
  - Palo Alto, California, United States, 94304
    - VA Palo Alto Health Care System
- Florida
  - Aventura, Florida, United States, 33180
    - UM Sylvester Comprehensive Cancer Center at Aventura
  - Coral Gables, Florida, United States, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Coral Springs, Florida, United States, 33065
    - UM Sylvester Comprehensive Cancer Center at Coral Springs
  - Deerfield Beach, Florida, United States, 33442
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Hollywood, Florida, United States, 33021
    - UM Sylvester Comprehensive Cancer Center at Hollywood
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, United States, 33176
    - UM Sylvester Comprehensive Cancer Center at Kendall
  - Plantation, Florida, United States, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, United States, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Health - Coeur d'Alene
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, United States, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, United States, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
- Illinois
  - Barrington, Illinois, United States, 60010
    - Advocate Good Shepherd Hospital
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60612
    - John H Stroger Jr Hospital of Cook County
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Crystal Lake, Illinois, United States, 60014
    - AMG Crystal Lake - Oncology
  - Danville, Illinois, United States, 61832
    - Carle at The Riverfront
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Downers Grove, Illinois, United States, 60515
    - Advocate Good Samaritan Hospital
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Elgin, Illinois, United States, 60123
    - Advocate Sherman Hospital
  - Hazel Crest, Illinois, United States, 60429
    - Advocate South Suburban Hospital
  - Libertyville, Illinois, United States, 60048
    - Condell Memorial Hospital
  - Libertyville, Illinois, United States, 60048
    - AMG Libertyville - Oncology
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Normal, Illinois, United States, 61761
    - Carle Cancer Institute Normal
  - Normal, Illinois, United States, 61761
    - Carle BroMenn Medical Center
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Oak Lawn, Illinois, United States, 60453-2699
    - Advocate Christ Medical Center
  - Oak Lawn, Illinois, United States, 60453
    - Advocate Outpatient Center - Oak Lawn
  - Palos Heights, Illinois, United States, 60463
    - Advocate High Tech Medical Park
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Shiloh, Illinois, United States, 62269
    - Memorial Hospital East
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Iowa
  - Ankeny, Iowa, United States, 50023
    - UI Health Care Mission Cancer and Blood - Ankeny Clinic
  - Des Moines, Iowa, United States, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, United States, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Waukee, Iowa, United States, 50263
    - UI Health Care Mission Cancer and Blood - Waukee Clinic
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
- Maine
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Bethesda, Maryland, United States, 20892
    - National Institutes of Health Clinical Center
  - Bethesda, Maryland, United States, 20889-5600
    - Walter Reed National Military Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, United States, 48114
    - Trinity Health Medical Center - Brighton
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health Medical Center - Canton
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, United States, 48118
    - Chelsea Hospital
  - Dearborn, Michigan, United States, 48124
    - Corewell Health Dearborn Hospital
  - Farmington Hills, Michigan, United States, 48336
    - Corewell Health Farmington Hills Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48503
    - Cancer Hematology Centers - Flint
  - Lansing, Michigan, United States, 48912
    - University of Michigan Health - Sparrow Lansing
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Pontiac, Michigan, United States, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Royal Oak, Michigan, United States, 48073
    - Corewell Health William Beaumont University Hospital
  - Royal Oak, Michigan, United States, 48073
    - Corewell Health Children's
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, United States, 48601
    - MyMichigan Medical Center Saginaw
  - Tawas City, Michigan, United States, 48764
    - MyMichigan Medical Center Tawas
  - Troy, Michigan, United States, 48085
    - Corewell Health Beaumont Troy Hospital
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
- Minnesota
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - City of Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - St Louis, Missouri, United States, 63136
    - Siteman Cancer Center at Christian Hospital
- Montana
  - Anaconda, Montana, United States, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, United States, 59405
    - Benefis Sletten Cancer Institute
  - Kalispell, Montana, United States, 59901
    - Logan Health Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, United States, 89183
    - OptumCare Cancer Care at Fort Apache
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
- New York
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Mineola, New York, United States, 11501
    - NYU Langone Hospital - Long Island
  - New York, New York, United States, 10016
    - Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Ohio
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Dayton, Ohio, United States, 45415
    - Dayton Physician LLC - Englewood
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Dublin, Ohio, United States, 43016
    - Dublin Methodist Hospital
  - Dublin, Ohio, United States, 43016
    - Columbus Oncology and Hematology Associates
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Ontario, Oregon, United States, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Willow Grove, Pennsylvania, United States, 19090
    - Asplundh Cancer Pavilion
- South Carolina
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Bristol Regional Medical Center
  - Johnson City, Tennessee, United States, 37604
    - Regional Cancer Center at Johnson City Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
- Texas
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Virginia
  - Bristol, Virginia, United States, 24201
    - Ballad Health Cancer Care - Bristol
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23298
    - VCU Massey Comprehensive Cancer Center
- Washington
  - Seattle, Washington, United States, 98122
    - Swedish Medical Center-First Hill
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston Division
- Wisconsin
  - Appleton, Wisconsin, United States, 54911
    - ThedaCare Regional Cancer Center
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Berlin, Wisconsin, United States, 54923
    - ThedaCare Cancer Care - Berlin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Cudahy, Wisconsin, United States, 53110
    - Aurora Saint Luke's South Shore
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Janesville, Wisconsin, United States, 53548
    - Mercyhealth Hospital and Cancer Center - Janesville
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Madison, Wisconsin, United States, 53718
    - University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
  - Marinette, Wisconsin, United States, 54143
    - Aurora Bay Area Medical Group-Marinette
  - Milwaukee, Wisconsin, United States, 53209
    - Aurora Cancer Care-Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Neenah, Wisconsin, United States, 54956
    - ThedaCare Regional Medical Center - Neenah
  - New London, Wisconsin, United States, 54961
    - ThedaCare Cancer Care - New London
  - Oshkosh, Wisconsin, United States, 54904
    - Vince Lombardi Cancer Clinic - Oshkosh
  - Oshkosh, Wisconsin, United States, 54904
    - ThedaCare Cancer Care - Oshkosh
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Shawano, Wisconsin, United States, 54166
    - ThedaCare Cancer Care - Shawano
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Two Rivers, Wisconsin, United States, 54241
    - Vince Lombardi Cancer Clinic-Two Rivers
  - Waupaca, Wisconsin, United States, 54981
    - ThedaCare Cancer Care - Waupaca
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-E5 based on the presence of an actionable mutation as defined in EAY191
Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study
Patient must be >= 18 years of age
Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment
Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191-E5)
- NOTE: The current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
- NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
Patient must have cytologically/histologically confirmed advanced/metastatic solid tumor
Patient must have progressed on at least one line of standard of care therapy in the advanced/metastatic setting
- NOTE: Patients who have progressed on a prior human epidermal growth factor receptor (EGFR) inhibitor will meet this criterion
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 (or Karnofsky performance status >= 60%)
Patient must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) documented by imaging obtained within 28 days prior to registration/randomization
Patient must not have any serious active infection within 4 weeks prior to EAY191-E5 registration/randomization (e.g., requiring hospitalization and/or intravenous [IV] antibiotics) or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible
Patient must have the ability to retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption
Patient must not have any history of or current evidence of non-infectious interstitial lung disease (ILD)/pneumonitis
Patient must not have a history of allergic reactions attributed to either of the study agents or to agents of similar chemical or biologic composition
Patient must have completed full treatment cycle 21 days prior to EAY191-E5 registration/randomization if they have received prior chemotherapy, biological cancer therapy, radiation therapy or an investigational agent/device. Patients must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from any adverse events due to prior cancer therapy (with the exception of alopecia)
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration/randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for at least 6 months after the last dose of protocol treatment. Patients must not breastfeed while receiving protocol treatment and for one week (7 days) after the last dose of AMG 510 (sotorasib) and 2 months after the last dose of panitumumab
Patients must not have neuropathy ≥ grade 2 within 14 days prior to registration/randomization
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Human immunodeficiency virus (HIV)-infected patients no effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac history, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trail, patients should be class 2B or better
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 28 days prior to protocol registration/randomization)
Aspartate aminotransferase (AST) (serum (glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase ([SGPT]) < 3 x institutional upper limit of normal (obtained ≤ 28 days prior to protocol registration/randomization)
Creatinine =< 1.5 x institutional ULN OR creatinine clearance > 50 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL as per Cockcroft-Gault (obtained ≤ 28 days prior to protocol registration/randomization)
COHORT I: Patient must not have colorectal cancer or non-small cell lung cancer
COHORT I: Patient must not have been previously treated with a KRAS G12C inhibitor
COHORT II: Patient must have progressed after treatment at the recommended phase II dose (RP2D) of any KRAS G12C inhibitor
- NOTE: Patients on cohort 1 who experience progression on Regimen 2 (AMG 510 [sotorasib] alone) may be eligible to enroll on cohort 2 and receive combination treatment with panitumumab and AMG 510 (sotorasib). Patients must meet performance status requirements and laboratory values as above and must be begin treatment within 7 days of enrollment. Migration to cohort 2 must take place within 6 months of progression, with no intervening anti-cancer therapy given.
- NOTE: Cohort migration following disease progression is dependent on a slot being available. MATCHBox makes the new treatment assignment following initiation of a step 2 registration for this treatment trial
COHORT II: Patient must not have been previously treated with a KRAS G12C inhibitor in combination with an EGFR inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort II (sotorasib, panitumumab) Patients receive combination therapy as in Arm A.	Procedure: Biospecimen Collection Undergo collection of blood Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix E7.6.3 Human IgG2K Monoclonal Antibody MoAb E7.6.3 Monoclonal Antibody E7.6.3 Procedure: Computed Tomography Undergo CT scan Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Drug: Sotorasib Given PO Other Names: AMG 510 Lumakras AMG-510 AMG510 Lumykras Procedure: Biopsy Procedure Undergo tumor biopsy Other Names: Bx BIOPSY_TYPE Biopsy
Experimental: Cohort I Arm A (sotorasib, panitumumab) Patients receive sotorasib PO QD on days 1-28 and panitumumab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.	Procedure: Biospecimen Collection Undergo collection of blood Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix E7.6.3 Human IgG2K Monoclonal Antibody MoAb E7.6.3 Monoclonal Antibody E7.6.3 Procedure: Computed Tomography Undergo CT scan Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Drug: Sotorasib Given PO Other Names: AMG 510 Lumakras AMG-510 AMG510 Lumykras Procedure: Biopsy Procedure Undergo tumor biopsy Other Names: Bx BIOPSY_TYPE Biopsy
Active Comparator: Cohort I Arm B (sotorasib) Patients receive sotorasib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross-over to cohort II. Patients also undergo collection of blood samples, biopsy, and CT or MRI on study.	Procedure: Biospecimen Collection Undergo collection of blood Other Names: Biological Sample Collection Biospecimen Collected Specimen Collection Sample Collection Procedure: Magnetic Resonance Imaging Undergo MRI Other Names: MRI Magnetic Resonance Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) sMRI Magnetic resonance imaging (procedure) MRIs Structural MRI Procedure: Computed Tomography Undergo CT scan Other Names: CT CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT Scan tomography Computerized axial tomography (procedure) Computerized Tomography (CT) scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type Drug: Sotorasib Given PO Other Names: AMG 510 Lumakras AMG-510 AMG510 Lumykras Procedure: Biopsy Procedure Undergo tumor biopsy Other Names: Bx BIOPSY_TYPE Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) (Cohort I) Time Frame: From registration to documented disease progression or death from any cause, assessed up to 3 years	PFS will be compared between the arms using a one-sided log rank test with 10% type I error. Cox's proportional hazards model will be used to estimate the PFS hazard ratio between the treatment arms and a two-sided 80% confidence interval will be reported (to correspond to the one-sided 10% type I error). Confidence intervals on most other quantities will use the two-sided 90% level.	From registration to documented disease progression or death from any cause, assessed up to 3 years
Best objective response (Cohort II) Time Frame: From the start of the treatment until disease progression/recurrence, assessed up to 3 years	Will be evaluated using the criteria defined by Response Evaluation Criteria in Solid Tumors) version 1.1 for patients with solid tumors.	From the start of the treatment until disease progression/recurrence, assessed up to 3 years
Overall response rate (ORR) (Cohort II) Time Frame: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years	The exact 90% confidence interval on the ORR (determined using the method of Atkinson and Brown) will be reported. If the number of analyzable cases is less than 35, a 5% one-sided test will still be used.	From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) (Cohort I) Time Frame: Up to 3 years	OS distributions by treatment will be estimated and 90% confidence intervals on estimated rates at 6 and 12 months will be reported. The OS hazard ratio will be estimated using Cox proportional hazards model and a 90% confidence interval reported.	Up to 3 years
ORR (Cohort I) Time Frame: Up to 3 years	Will be compared using Fisher's exact test and exact 90% confidence intervals for the rates in each arm will be computed.	Up to 3 years
Disease control rates (Cohort I) Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 3 years	Will be compared using Fisher's exact test and exact 90% confidence intervals for the rates in each arm will be computed.	From the start of the treatment until the criteria for progression are met, assessed up to 3 years
PFS (Cohort II) Time Frame: At 6 and 12 months, assessed up to 3 years	Will be estimated and 90% confidence intervals on estimated rates will be reported.	At 6 and 12 months, assessed up to 3 years
OS (Cohort II) Time Frame: At 6 and 12 months, assessed up to 3 years	Will be estimated and 90% confidence intervals on estimated rates will be reported.	At 6 and 12 months, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Kristen R Spencer, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2022-09876 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180820 (U.S. NIH Grant/Contract)
EAY191-E5 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Advanced Malignant Solid Neoplasm

Clinical Trials on Biospecimen Collection

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