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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Divarasib will be administered orally QD
Pembrolizumab will be administered via IV infusion Q3W
Pemetrexed will be administered via IV infusion Q3W
Carboplatin will be administered via IV infusion Q3W
Cisplatin will be administered via IV infusion Q3W
Alaska Oncology and Hematology
Anchorage, Alaska, United States
RECRUITINGMarin Cancer Care Inc
Greenbrae, California, United States
RECRUITINGBioResearch Partner
Hialeah, Florida, United States
RECRUITINGPiedmont Cancer Institute, PC
Atlanta, Georgia, United States
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
Objective Response
Objective response is defined as complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by BICR according to RECIST v1.1
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)
DOR is defined as the time from the first occurrence of a documented 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 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
Reference Study ID Number: CO45042 https://forpatients.roche.com/
CONTACT
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Summit Cancer Care PC
Savannah, Georgia, United States
RECRUITINGSt. Luke's Cancer Institute
Boise, Idaho, United States
RECRUITINGHope and Healing Cancer Services
Hinsdale, Illinois, United States
WITHDRAWNProfound Research, LLC
Farmington Hills, Michigan, United States
RECRUITINGMissouri Baptist Medical Center
St Louis, Missouri, United States
RECRUITINGSan Juan Oncology Associates
Farmington, New Mexico, United States
RECRUITING...and 141 more locations