The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
Participants will receive IV carboplatin Q3W for four 21-day cycles.
Participants will receive IV cisplatin Q3W for four 21-day cycles.
Participants will receive IV pemetrexed Q3W.
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGCity of Hope - Seacliff
Huntington Beach, California, United States
RECRUITINGCity of Hope at Irvine Lennar
Irvine, California, United States
RECRUITINGUCSD Moores Cancer Center
La Jolla, California, United States
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Objective Response Rate (ORR)
The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 5 years
Duration of Response (DOR)
The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Approximately 5 years
Progression Free Survival (PFS)
The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Approximately 5 years
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Approximately 5 years
Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE
Time frame: Baseline up to approximately 5 years
Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria
Time frame: Approximately 5 years
Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE
Time frame: Approximately 5 years
Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
Time frame: Approximately 5 years
Plasma or CSF Concentration of Divarasib at Specified Timepoints
Optional CSF samples may be collected at the time of disease progression or at any time during the study for participants who have provided written consent and if collection of CSF sample is deemed clinically feasible. Matched optional plasma samples may be drawn at the same time.
Time frame: Approximately 5 years
Identification of Divarasib Recommended Dose
The recommended dose will be based upon the totality of safety, activity, and PK data.
Time frame: Approximately 5 years
Central Nervous System (CNS) Response
Defined as the percentage of participants who experience a complete response or partial response in the brain, as determined by the investigator according to modified RECIST
Time frame: Approximately 5 years
Reference Study ID Number: BO44426 https://forpatients.roche.com/
CONTACT
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City of Hope - Long Beach Elm
Long Beach, California, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers, Florida, United States
RECRUITINGFlorida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida, United States
RECRUITINGNYU Langone Hospital - Long Island
Mineola, New York, United States
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