A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Summary
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Arms & interventions
- DrugDivarasib
Divarasib will be administered orally QD
- DrugPembrolizumab
Pembrolizumab will be administered via IV infusion Q3W
- DrugPemetrexed
Pemetrexed will be administered via IV infusion Q3W
- DrugCarboplatin
Carboplatin will be administered via IV infusion Q3W
- DrugCisplatin
Cisplatin will be administered via IV infusion Q3W
Outcome measures
Primary
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)
Time frame: Up to approximately 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Time frame: Up to approximately 5 years
Secondary
Objective Response
Time frame: Up to approximately 5 years
Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale
Time frame: Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale
Time frame: Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Up to approximately 5 years
Change from Baseline in the Severity of Selected Symptomatic Treatment Toxicities as Assessed Through use of the NCI PRO-CTCAE
Time frame: Up to approximately 5 years
Frequency of Participants' Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the single-item EORTC Item List (IL46)
Time frame: Up to approximately 5 years
Change from Baseline on the EORTC QLQ-C30 and QLQ-LC13 Functional and Global Health Status Score/Quality of Life Score (GHS/QoL)
Time frame: Up to approximately 5 years
Eligibility criteria
Study locations (50)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
City of Hope - Phoenix
Goodyear, Arizona, 85338
Marin Cancer Care Inc
Greenbrae, California, 94904
Hoag Memorial Hospital
Newport Beach, California, 92658
Palo Alto Medical Foundation Research Center
Palo Alto, California, 94301
Sutter Institute for Medical Research
Roseville, California, 95661
California Pacific Medical Center
San Francisco, California, 94115
UC Health Oncology Research
Colorado Springs, Colorado, 80909
Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System
Fort Collins, Colorado, 80528
Hartford Hospital
Hartford, Connecticut, 06102-5037
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers, Florida, 33901-8108
University of Florida Health at Shands
Gainesville, Florida, 32610
BioResearch Partner
Hialeah, Florida, 33013
Memorial Healthcare System - Memorial Regional Hospital
Hollywood, Florida, 33021
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Ascension Sacred Heart
Pensacola, Florida, 32504
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, 33701
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, 33401-3406
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318
City of Hope® Atlanta
Newnan, Georgia, 30265
Summit Cancer Care PC
Savannah, Georgia, 31405
St. Luke's Cancer Institute
Boise, Idaho, 83712
Affiliated Oncologists, LLC
Chicago Ridge, Illinois, 60415
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
City of Hope® Cancer Center Chicago
Zion, Illinois, 60099
Mission Cancer + Blood - IMMC
Des Moines, Iowa, 50309
University of Iowa
Iowa City, Iowa, 52242
Saint Agnes Hospital - Baltimore - Hunt - PPDS
Baltimore, Maryland, 21229-5201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Profound Research, LLC
Farmington Hills, Michigan, 48334
Missouri Baptist Medical Center
St Louis, Missouri, 63131
NHO Revive Research Institute
Lincoln, Nebraska, 68506
San Juan Oncology Associates
Farmington, New Mexico, 87401
Montefiore Einstein Cancer Center
The Bronx, New York, 10461
Clinical Research Alliance
Westbury, New York, 11590
Firsthealth of The Carolinas
Pinehurst, North Carolina, 28374
Ohio State University
Columbus, Ohio, 43210
Oregon Health and Science University
Portland, Oregon, 97239
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania, 19611
Baptist Cancer Center
Memphis, Tennessee, 38120
Renovatio Clinical - El Paso
El Paso, Texas, 79915
JPS Health Network
Fort Worth, Texas, 76104
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
Community Clinical Trials
Kingwood, Texas, 77339
Texas Tech Health Science Center
Lubbock, Texas, 79415
Renovatio Clinical
The Woodlands, Texas, 77380
University of Texas Health Center at Tyler
Tyler, Texas, 75708
Virginia Oncology Associates
Norfolk, Virginia, 23502