A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02
Summary
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
Arms & interventions
- DrugOlomorasib
Administered orally.
- DrugPembrolizumab
Administered intravenously (IV).
- DrugDurvalumab
Administered IV.
- DrugPlacebo
Administered orally.
Outcome measures
Primary
Part A: Disease-Free Survival (DFS) by Investigator Assessment
DFS by Investigator Assessment
Time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).
Part B: Progression-Free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Secondary
Part A & B: Overall Survival (OS)
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 5 years).
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: PFS
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years)
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Time to Response (TTR) per RECIST 1.1 by BICR and Investigator
Time frame: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment
Time frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Eligibility criteria
Study locations (88)
Clearview Cancer Institute
Huntsville, Alabama, 35805
Infirmary Cancer Care
Mobile, Alabama, 36607
City of Hope, Phoenix
Phoenix, Arizona, 85338
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, 85719
Highlands Oncology Group
Springdale, Arkansas, 72762
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
Profound Research LLC
Oceanside, California, 92056
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868
Stanford Cancer Center
Palo Alto, California, 94304
Kaiser Permanente San Diego Mission Road
San Diego, California, 92108
BASS Cancer Center
Walnut Creek, California, 94598
Hartford Hospital (HH)
Hartford, Connecticut, 06102
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Boca Raton Regional Hospital
Boca Raton, Florida, 33486
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
Ocala, Florida, 34474
Florida Cancer Specialists North
St. Petersburg, Florida, 33701-4553
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Moffitt Cancer Center
Tampa, Florida, 33612
Florida Cancer Specialists East
West Palm Beach, Florida, 33401
Winship Cancer Institute
Atlanta, Georgia, 30322
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, Georgia, 30265
City of Hope, Chicago
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Springfield Clinic Main Campus
Springfield, Illinois, 62703
Parkview Research Center at Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Franciscan Health
Indianapolis, Indiana, 46237
Baptist Health Lexington
Lexington, Kentucky, 40503
Baptist Health Hamburg
Lexington, Kentucky, 40509
CHI Saint Joseph Cancer Center - East
Lexington, Kentucky, 40509
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Ochsner Health Ochsner Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70816
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
New England Cancer Specialists
Westbrook, Maine, 04092
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
James M Stockman Cancer Institute
Frederick, Maryland, 21702
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Reliant Medical Group
Worcester, Massachusetts, 01606
Karmanos Cancer Institute
Detroit, Michigan, 48201
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Jefferson Health - Cherry Hill
Cherry Hill, New Jersey, 08002
Sidney Kimmel Cancer Center - Washington Township
Sewell, New Jersey, 08080
Columbia University Irving Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Northport VA Medical Center
Northport, New York, 11768
WakeMed Raleigh Campus
Raleigh, North Carolina, 27610
Aultman Hospital
Canton, Ohio, 44710
Miami Valley Hospital South
Centerville, Ohio, 45459
Cleveland Clinic
Cleveland, Ohio, 44195
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T
Columbus, Ohio, 43210
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Providence Portland Medical Center
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office
Philadelphia, Pennsylvania, 19107
Jefferson Hospital Northeast
Philadelphia, Pennsylvania, 19114
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Medical University of South Carolina
Charleston, South Carolina, 29425
Lexington Medical Center
West Columbia, South Carolina, 29169
Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37203
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Kelsey-Seybold Clinic
Houston, Texas, 77025
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
USO - Texas Oncology - San Antonio
San Antonio, Texas, 78240
USO - Texas Oncology Gulf Coast
Sugar Land, Texas, 77479
USO - US Oncology Research Network
The Woodlands, Texas, 77380
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05405
University of Virginia Health System
Charlottesville, Virginia, 22903
VCU Health Adult Outpatient Pavillion
Richmond, Virginia, 23219
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Swedish Medical Center
Seattle, Washington, 98104
Cancer Care Northwest - Vercler
Spokane Valley, Washington, 99216
Northwest Cancer Specialists PC
Vancouver, Washington, 98684
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226