The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
Administered orally.
Administered intravenously (IV).
Administered IV.
Administered orally.
Clearview Cancer Institute
Huntsville, Alabama, United States
RECRUITINGInfirmary Cancer Care
Mobile, Alabama, United States
NOT_YET_RECRUITINGThe University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
Part A: Disease-Free Survival (DFS) by Investigator Assessment
DFS by Investigator Assessment
Time frame: Randomization to disease recurrence or death from any cause (Estimated as approximately 48 months).
Part B: Progression-Free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR)
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part A & B: Overall Survival (OS)
OS
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 5 years).
Part A & B: Change from baseline in health-related quality of life (HRQoL), measured by European Organization for Research & Treatment of CancerQualityofLifeQuestionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in HRQoL, measured by the EORTC QLQ-C30
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Objective Response Rate (ORR) per RECIST 1.1 by BICR
ORR per RECIST 1.1 by BICR
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Duration of Response (DOR) per RECIST 1.1 by BICR
DOR per RECIST 1.1 by BICR
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Disease Control Rate (DCR) per RECIST 1.1 by BICR
DCR per RECIST 1.1 by BICR
Time frame: Randomization to disease progression or death from any cause (Estimated as approximately 3 years).
Part B: Time to Response (TTR) per RECIST 1.1 by BICR
TTR per RECIST 1.1 by BICR
Time frame: Randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 3 years).
Part B: Progression-Free Survival 2 (PFS2) by investigator assessment
PFS2 by investigator assessment
Time frame: Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 3 years).]
Part B: Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (SAQ)
Changes in NSCLC-related symptoms, measured by the NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time to worsening of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Part B: Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Changes in patient-reported pulmonary symptoms of cough, chest pain, and dyspnea, measured by NSCLC-SAQ
Time frame: Randomization through end of treatment (Estimated as approximately 3 years).
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, United States
NOT_YET_RECRUITINGProfound Research LLC
Oceanside, California, United States
RECRUITINGUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, United States
NOT_YET_RECRUITINGStanford Cancer Center
Palo Alto, California, United States
RECRUITINGKaiser Permanente San Diego Mission Road
San Diego, California, United States
RECRUITINGBASS Cancer Center
Walnut Creek, California, United States
RECRUITING...and 341 more locations