Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
oral dose of 400 mg twice daily tablets
IV infusion once every 3 weeks
IV infusion once every 3 weeks
Objective Response Rate (ORR) for Cohort A and E
Defined as the percent of patients documented to have a confirmed CR or PR
Time frame: 30 months
Progression-free Survival (PFS) at six months for Cohort C
PFS is defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time frame: 30 months
Adverse Events
Defined as number of patients with treatment emergent AEs
Time frame: 30 months
Duration of Response (DOR)
Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Time frame: 30 months
Overall Survival (OS)
Defined as time from date of first study treatment to date of death due to any cause
Time frame: 30 months
Progression-free Survival (PFS)
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time frame: 30 months
Population pharmacokinetic (PK) Model Derived AUC at Steady State (AUCtau,ss).
Concentration data from this study will be pooled with other studies and exposure parameters derived using population PK methods. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed to report results from participants enrolled in the study and described in the Participant Flow module.
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IV infusion once every 3 weeks
Local Institution - Unk025
Anchorage, Alaska, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 017-591
Glendale, Arizona, United States
WITHDRAWNLocal Institution - 017-821
Phoenix, Arizona, United States
WITHDRAWNLocal Institution - Unk047
Anaheim, California, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 017-936C
Fountain Valley, California, United States
NOT_YET_RECRUITINGMemorialCare - Orange Coast Medical Center
Fountain Valley, California, United States
RECRUITINGProvidence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
Fullerton, California, United States
RECRUITINGLocal Institution - Unk004
Loma Linda, California, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 017-961
Los Angeles, California, United States
WITHDRAWNUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
RECRUITING...and 156 more locations
Time frame: Time Frame: Pre-dose and 4-6 hours post dose; up to 6 months
Cohorts C and E: DLTs during SLI (Safety Lead In)
Defined as those patients in the SLI of the study who have received at least 80% of the assigned dose of adagrasib during the first cycle on study, or interrupted or discontinued study treatment during the first cycle due to a DLT.
Time frame: 30 months