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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03600883
Registration number
NCT03600883
Ethics application status
Date submitted
26/06/2018
Date registered
26/07/2018
Date last updated
13/05/2024
Titles & IDs
Public title
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
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Scientific title
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
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Secondary ID [1]
0
0
20170543
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
KRAS p.G12C Mutant Advanced Solid Tumors
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - sotorasib
Treatment: Drugs - Anti PD-1/L1
Treatment: Drugs - Midazolam
Experimental: Phase 1 Dose Exploration Part 1 monotherapy - Cohorts with food effect and alternative dosing regimens
Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
Experimental: Phase 1 Dose Expansion Part 2 monotherapy - Upon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 3 groups may be done concurrently
Experimental: Phase 1 combination arm with sotorasib and anti PD-1/L1 - Additional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1)
Experimental: Phase 1 monotherapy treatment naive advanced NSCLC - Separate cohort of part 1 dose expansion subjects to evaluate the safety and clinical activity of sotorasib administered orally once daily in subjects with previously untreated advanced non-small cell lung cancer (NSCLC). Drug-drug interaction will be evaluated in 6 of the subjects enrolled in the treatment naive cohort by adding Midazolam alone on Day -1 and in combination with sotorasib on Day 15 of Cycle 1, where each cycle is 21 days.
Experimental: Phase 2 monotherapy dose comparison - Subjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy
Experimental: Phase 1 Does escalation and Expansion monotherapy BID - BID 2L+solid tumors (fed state)
Treatment: Drugs: sotorasib
Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral Tablet formulation
Treatment: Drugs: Anti PD-1/L1
Administered as an intravenous (IV) infusion
Treatment: Drugs: Midazolam
Administered as an oral hydrochloride (HCI) syrup
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Primary: Number of subjects with treatment-emergent adverse events
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Assessment method [1]
0
0
Treatment-emergent adverse events will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
Phase 2 monotherapy dose comparison
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Timepoint [1]
0
0
24 Months
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Primary outcome [2]
0
0
Primary: Number of subjects with treatment-related adverse events
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Assessment method [2]
0
0
Treatment-related adverse events will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [2]
0
0
24 Months
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Primary outcome [3]
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0
Primary: Number of subjects with grade =3 treatment-emergent adverse events
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Assessment method [3]
0
0
Grade =3 treatment-emergent adverse events will be a primary outcome measure in the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [3]
0
0
24 Months
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Primary outcome [4]
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0
Primary: Number of subjects with serious adverse events
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Assessment method [4]
0
0
Serious adverse events will be a primary outcome measure in the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [4]
0
0
24 Months
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Primary outcome [5]
0
0
Primary: Number of subjects with adverse events of interest
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Assessment method [5]
0
0
Adverse events of interest will be a primary outcome measure in the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [5]
0
0
24 Months
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Primary outcome [6]
0
0
Primary: Number of subjects with clinically significant changes in vital signs
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Assessment method [6]
0
0
Vital signs will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [6]
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0
Baseline to 24 Months
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Primary outcome [7]
0
0
Primary: Number of subjects with clinically significant changes in physical examination results
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Assessment method [7]
0
0
Physical examinations will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
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Timepoint [7]
0
0
Baseline to 24 Months
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Primary outcome [8]
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0
Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
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Assessment method [8]
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0
ECGs will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [8]
0
0
Baseline to 24 Months
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Primary outcome [9]
0
0
Primary: Number of subjects with clinically significant changes in clinical laboratory values
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Assessment method [9]
0
0
Abnormal clinical laboratory values will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [9]
0
0
Baseline to 24 Months
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Primary outcome [10]
0
0
Primary: Number of subjects with dose-limiting toxicities (DLTs)
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Assessment method [10]
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0
DLTs will be a primary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [10]
0
0
21 Days
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Primary outcome [11]
0
0
Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
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Assessment method [11]
0
0
ORR will be a primary outcome measure in the following group:
Phase 1 monotherapy treatment naïve advanced NSCLC
Phase 2 monotherapy
Phase 2 monotherapy dose comparison
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Timepoint [11]
0
0
24 Months
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Primary outcome [12]
0
0
Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
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Assessment method [12]
0
0
DOR will be a primary outcome measure in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [12]
0
0
24 Months
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Primary outcome [13]
0
0
Primary: Disease control as assessed by RECIST 1.1 criteria
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Assessment method [13]
0
0
Disease control will be a primary outcome measure in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [13]
0
0
24 Months
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Primary outcome [14]
0
0
Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
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Assessment method [14]
0
0
Duration of SD will be a primary outcome measure in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [14]
0
0
24 Months
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Primary outcome [15]
0
0
Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
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Assessment method [15]
0
0
TTR will be a primary outcome measure in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [15]
0
0
24 Months
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Secondary outcome [1]
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0
Secondary: Plasma concentration (Cmax) of sotorasib
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Assessment method [1]
0
0
Cmax will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
Phase 2 monotherapy dose comparison
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Timepoint [1]
0
0
15 Weeks
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Secondary outcome [2]
0
0
Secondary: Plasma concentration (Cmax) of midazolam
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Assessment method [2]
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Cmax of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [2]
0
0
16 Days
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Secondary outcome [3]
0
0
Secondary: Time to achieve Cmax (Tmax) of sotorasib
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Assessment method [3]
0
0
Tmax will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [3]
0
0
15 Weeks
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Secondary outcome [4]
0
0
Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib
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Assessment method [4]
0
0
AUC will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 1 monotherapy treatment naïve advanced NSCLC
Phase 2 monotherapy dose comparison
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Timepoint [4]
0
0
15 Weeks
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Secondary outcome [5]
0
0
Secondary: Area under the plasma concentration-time curve (AUC) of midazolam
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Assessment method [5]
0
0
AUC of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [5]
0
0
16 Days
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Secondary outcome [6]
0
0
Secondary: Clearance of midazolam from the plasma
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Assessment method [6]
0
0
Clearance of midazolam from the plasma will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [6]
0
0
16 Days
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Secondary outcome [7]
0
0
Secondary: Terminal half-life (t1/2) of midazolam
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Assessment method [7]
0
0
t1/2 of midazolam will be a secondary outcome measure for the subgroup of subjects who were administered midazolam in the following group:
- Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [7]
0
0
16 Days
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Secondary outcome [8]
0
0
Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
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Assessment method [8]
0
0
ORR will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
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Timepoint [8]
0
0
24 Months
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Secondary outcome [9]
0
0
Secondary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
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Assessment method [9]
0
0
DOR will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 2 monotherapy dose comparison
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Timepoint [9]
0
0
24 Months
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Secondary outcome [10]
0
0
Secondary: Disease control as assessed by RECIST 1.1 criteria
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Assessment method [10]
0
0
DOR will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 2 monotherapy dose comparison
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Timepoint [10]
0
0
24 Months
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Secondary outcome [11]
0
0
Secondary: Progression-free survival (PFS) as assessed by RECIST 1.1 criteria
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Assessment method [11]
0
0
PFS will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 2 monotherapy dose comparison
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [11]
0
0
24 Months
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Secondary outcome [12]
0
0
Secondary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
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Assessment method [12]
0
0
Duration of SD will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
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Timepoint [12]
0
0
24 Months
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Secondary outcome [13]
0
0
Secondary: Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria
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Assessment method [13]
0
0
Depth of response will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [13]
0
0
Baseline to 24 Months
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Secondary outcome [14]
0
0
Secondary: Time to response (TTR) as assessed by RECIST 1.1 criteria
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Assessment method [14]
0
0
DOR will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 2 monotherapy dose comparison
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Timepoint [14]
0
0
24 Months
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Secondary outcome [15]
0
0
Secondary: Overall survival (OS)
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Assessment method [15]
0
0
OS will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
Phase 2 monotherapy
Phase 1 combination arm with sotorasib and anti PD-1/L1
Phase 2 monotherapy dose comparison
Phase 1 monotherapy treatment naïve advanced NSCLC
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Timepoint [15]
0
0
24 Months
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Secondary outcome [16]
0
0
Secondary: sotorasib exposure and QTc interval relationship
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Assessment method [16]
0
0
sotorasib exposure and QTc interval relationship will be a secondary outcome measure for the following groups:
Phase 1 Dose Exploration Part 1 monotherapy
Phase 1 Dose Expansion Part 2 monotherapy
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Timepoint [16]
0
0
24 Months
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Secondary outcome [17]
0
0
Secondary: Progression-free survival (PFS) at 6 months
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Assessment method [17]
0
0
PFS at 6 months will be a secondary outcome measure for the following group:
- Phase 2 monotherapy
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Timepoint [17]
0
0
6 Months
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Secondary outcome [18]
0
0
Secondary: Progression-free survival (PFS) at 12 months
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Assessment method [18]
0
0
PFS at 12 months will be a secondary outcome measure for the following group:
- Phase 2 monotherapy
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Timepoint [18]
0
0
12 Months
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Secondary outcome [19]
0
0
Secondary: Overall survival (OS) at 12 months
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Assessment method [19]
0
0
OS at 12 months will be a secondary outcome measure for the following group:
- Phase 2 monotherapy
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Timepoint [19]
0
0
12 Months
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Secondary outcome [20]
0
0
Secondary: Number of subjects with treatment-emergent adverse events
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Assessment method [20]
0
0
Treatment-emergent adverse events will be a secondary outcome measure for the following group:
- Phase 2 monotherapy
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Timepoint [20]
0
0
24 Months
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Secondary outcome [21]
0
0
Secondary: Number of subjects with grade =3 treatment-emergent adverse events
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Assessment method [21]
0
0
Grade =3 treatment-emergent adverse events will be a secondary outcome measure for the following group:
- Phase 2 monotherapy
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Timepoint [21]
0
0
24 Months
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Secondary outcome [22]
0
0
Secondary: Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30
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Assessment method [22]
0
0
Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [22]
0
0
24 Months
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Secondary outcome [23]
0
0
Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by disease-specific modules Quality-of-Life Questionnaire Lung Cancer Module (QLQ LC13)
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Assessment method [23]
0
0
Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [23]
0
0
24 Months
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Secondary outcome [24]
0
0
Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by non-small cell lung cancer symptom assessment questionnaire (NSCLC SAQ) for NSCLC
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Assessment method [24]
0
0
Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [24]
0
0
24 Months
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Secondary outcome [25]
0
0
Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Severity (PGIS)
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Assessment method [25]
0
0
Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [25]
0
0
24 Months
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Secondary outcome [26]
0
0
Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Change (PGIC) in cough, dyspnea and chest pain for NSCLC
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Assessment method [26]
0
0
Impact of treatment on disease-related symptoms and HRQOL will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [26]
0
0
24 Months
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Secondary outcome [27]
0
0
Secondary: Treatment-related symptoms and impact on the subject as assessed by EORTC QLQ-C30
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Assessment method [27]
0
0
Treament related symptoms and impact on the subject will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [27]
0
0
24 Months
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Secondary outcome [28]
0
0
Secondary: Treatment-related symptoms and impact on the subject as assessed by selected questions from the Patient-reported Outcome of the Common Terminology Criteria for Adverse Events (PRO-CTCAE library)
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Assessment method [28]
0
0
Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [28]
0
0
24 Months
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Secondary outcome [29]
0
0
Secondary: Treatment-related symptoms and impact on the subject as assessed by a single item about symptom bother, item GP5 of the Functional Assessment of Cancer Therapy - General (FACT-G)
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Assessment method [29]
0
0
Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [29]
0
0
24 Months
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Secondary outcome [30]
0
0
Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30
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Assessment method [30]
0
0
Treatment-related symptoms and impact on the subject will be a secondary outcome measure for the following group:
- Phase 2 monotherapy dose comparison
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Timepoint [30]
0
0
Baseline to 24 Months
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Eligibility
Key inclusion criteria
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C
mutation identified through molecular testing.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/11/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
713
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
0
0
Scientia Clinical Research Ltd - Randwick
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Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
0
0
The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [4]
0
0
Peter MacCallum Cancer Centre - Parkville
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Recruitment postcode(s) [1]
0
0
2031 - Randwick
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Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [3]
0
0
5011 - Woodville South
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Recruitment postcode(s) [4]
0
0
3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Delaware
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
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Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
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Country [13]
0
0
United States of America
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State/province [13]
0
0
North Carolina
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Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
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Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
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Country [16]
0
0
United States of America
Query!
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Funding & Sponsors
Primary sponsor type
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Name
Amgen
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Summary
Brief summary
Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant
advanced solid tumors.
Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult
subjects with KRAS p.G12C mutant advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03600883
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Trial related presentations / publications
Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
Skoulidis F, Li BT, Dy GK, Price TJ, Falchook GS, Wolf J, Italiano A, Schuler M, Borghaei H, Barlesi F, Kato T, Curioni-Fontecedro A, Sacher A, Spira A, Ramalingam SS, Takahashi T, Besse B, Anderson A, Ang A, Tran Q, Mather O, Henary H, Ngarmchamnanrith G, Friberg G, Velcheti V, Govindan R. Sotorasib for Lung Cancers with KRAS p.G12C Mutation. N Engl J Med. 2021 Jun 24;384(25):2371-2381. doi: 10.1056/NEJMoa2103695. Epub 2021 Jun 4.
Fakih MG, Kopetz S, Kuboki Y, Kim TW, Munster PN, Krauss JC, Falchook GS, Han SW, Heinemann V, Muro K, Strickler JH, Hong DS, Denlinger CS, Girotto G, Lee MA, Henary H, Tran Q, Park JK, Ngarmchamnanrith G, Prenen H, Price TJ. Sotorasib for previously treated colorectal cancers with KRASG12C mutation (CodeBreaK100): a prespecified analysis of a single-arm, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):115-124. doi: 10.1016/S1470-2045(21)00605-7. Epub 2021 Dec 15.
Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. doi: 10.1056/NEJMoa1917239. Epub 2020 Sep 20.
Zhao Y, Murciano-Goroff YR, Xue JY, Ang A, Lucas J, Mai TT, Da Cruz Paula AF, Saiki AY, Mohn D, Achanta P, Sisk AE, Arora KS, Roy RS, Kim D, Li C, Lim LP, Li M, Bahr A, Loomis BR, de Stanchina E, Reis-Filho JS, Weigelt B, Berger M, Riely G, Arbour KC, Lipford JR, Li BT, Lito P. Diverse alterations associated with resistance to KRAS(G12C) inhibition. Nature. 2021 Nov;599(7886):679-683. doi: 10.1038/s41586-021-04065-2. Epub 2021 Nov 10.
Dy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-Term Outcomes and Molecular Correlates of Sotorasib Efficacy in Patients With Pretreated KRAS G12C-Mutated Non-Small-Cell Lung Cancer: 2-Year Analysis of CodeBreaK 100. J Clin Oncol. 2023 Jun 20;41(18):3311-3317. doi: 10.1200/JCO.22.02524. Epub 2023 Apr 25.
Dy GK, Govindan R, Velcheti V, Falchook GS, Italiano A, Wolf J, Sacher AG, Takahashi T, Ramalingam SS, Dooms C, Kim DW, Addeo A, Desai J, Schuler M, Tomasini P, Hong DS, Lito P, Tran Q, Jones S, Anderson A, Hindoyan A, Snyder W, Skoulidis F, Li BT. Long-term benefit of sotorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: plain language summary. Future Oncol. 2024 Jan;20(3):113-120. doi: 10.2217/fon-2023-0560. Epub 2023 Nov 27.
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Public notes
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03600883
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