The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
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 4 years
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Time frame: Up to approximately 4 years
Confirmed Objective Response
Confirmed objective response is defined as complete response (CR) or partial response (PR) on two occasions ≥ 4 weeks apart, as determined by BICR according to RECIST v1.1
Time frame: Up to approximately 4 years
Time to Confirmed Deterioration (TTCD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Dyspnea Item and Physical Functioning Scale
Time frame: Baseline up to approximately 4 years
TTCD on the EORTC Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (QLQ-LC13) Cough Scale
Time frame: Baseline up to approximately 4 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a documented confirmed objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)
Time frame: Up to approximately 4 years
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 4 years
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Banner Health MD Anderson AZ
Gilbert, Arizona, United States
Los Angeles Cancer Network
Los Angeles, California, United States
UCLA Hematology / Oncology Clinic
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
St. Petersburg, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
New England Cancer Specialists
Westbrook, Maine, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
...and 141 more locations
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 4 years
Change from Baseline in Diarrhea, Nausea, Vomiting, Anorexia, Alopecia, Dyspnea, Cough, Constipation, Myalgia, Headache, and Rash/Acne as Assessed Through use of the NCI PRO-CTCAE
Time frame: Baseline up to approximately 4 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 4 years
Change from Baseline in Cough, Chest Pain, Dyspnea, Physical and Role Functioning, and Global Health Status score/Quality of Life Score (GHS/QoL) at Each Timepoint as Assessed Through use of the EORTC QLQ-LC13 and QLQ-C30
Time frame: Baseline up to approximately 4 years
TTCD on the EORTC QLQ-C30 Role Functioning and GHS/QoL scales
Time frame: Up to approximately 4 years
TTCD on the Chest Pain Scale of the QLQ-LC13 Scales
Time frame: Up to approximately 4 years