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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04613596
Registration number
NCT04613596
Ethics application status
Date submitted
28/10/2020
Date registered
3/11/2020
Titles & IDs
Public title
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
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Scientific title
A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
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Secondary ID [1]
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CA239-0009
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Secondary ID [2]
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CA239-0009
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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:
Advanced Non-Small Cell Lung Cancer
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0
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Metastatic Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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0
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0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
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0
0
0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Pembrolizumab
Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1% - Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1% - Cohort 1b: Adagrasib BID monotherapy
Experimental: Phase 2 Cohort 2: PD-L1 TPS =1% - Cohort 2: Adagrasib BID in combination with pembrolizumab
Experimental: Phase 3 Cohort 3 Investigational Arm - Adagrasib BID in combination with pembrolizumab
Active comparator: Phase 3 Cohort 4 Comparator Arm - Pembrolizumab
Treatment: Drugs: Adagrasib
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
Treatment: Drugs: Adagrasib
Adagrasib 600 mg BID monotherapy (Cohort 1b)
Treatment: Drugs: Adagrasib
adagrasib 400 mg BID in combination with pembrolizumab
Treatment: Drugs: Adagrasib
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg IV Q3W
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Intervention code [1]
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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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Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
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Assessment method [1]
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Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
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Timepoint [1]
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22 months
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Primary outcome [2]
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Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
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Assessment method [2]
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Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival
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Timepoint [2]
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36 months
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Secondary outcome [1]
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Phase 2: To characterize the safety and tolerability of study treatments in selected populations
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Assessment method [1]
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Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
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Timepoint [1]
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22 months
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Secondary outcome [2]
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Phase 2: Duration of Response
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Assessment method [2]
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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.
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Timepoint [2]
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22 months
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Secondary outcome [3]
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Phase 2: Progression Free Survival
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Assessment method [3]
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Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
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Timepoint [3]
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22 months
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Secondary outcome [4]
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Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
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Assessment method [4]
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1-Year Survival rate
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
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Assessment method [5]
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Overall Survival (OS)
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Timepoint [5]
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22 months
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Secondary outcome [6]
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Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
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Assessment method [6]
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Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
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Timepoint [6]
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22 months
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Secondary outcome [7]
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Phase 3: To evaluate the safety and tolerability in the study population
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Assessment method [7]
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Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
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Timepoint [7]
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36 months
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Secondary outcome [8]
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Phase 3: To evaluate the PK of adagrasib administered in the study population
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Assessment method [8]
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Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
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Timepoint [8]
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36 months
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Secondary outcome [9]
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Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
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Assessment method [9]
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Patient Reported Outcomes to measure quality of life
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Timepoint [9]
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36 months
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Secondary outcome [10]
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Phase 3: Progression Free Survival per RECIST 1.1 by Investigator
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Assessment method [10]
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Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
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Timepoint [10]
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36 months
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Secondary outcome [11]
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Phase 3: Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR
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Assessment method [11]
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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.
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Timepoint [11]
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36 months
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Secondary outcome [12]
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Phase 3: Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR
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Assessment method [12]
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Defined as the percent of patients documented to have a confirmed CR or PR.
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Timepoint [12]
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36 months
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Eligibility
Key inclusion criteria
* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%
* Phase 3: Presence of evaluable or measurable disease per RECIST
* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
1. No evidence of brain metastases
2. Untreated brain metastases not needing immediate local therapy
3. Previously treated brain metastases not needing immediate local therapy
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Minimum age
18
Years
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Maximum age
No limit
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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
* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
* Phase 2: Active brain metastases
* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
1. Any untreated brain lesions > 1.0 cm in size
2. Any brainstem lesions
3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization.
4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
* Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment
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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
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
2/12/2020
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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
31/10/2029
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Actual
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Sample size
Target
806
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Ballarat Regional Integrated Cancer Center - Ballarat
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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Local Institution - 007-004 - Clayton
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Local Institution - 007-006 - Garran
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Cancer Care Wollongong - Wollongong
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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3350 - Ballarat
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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2605 - Garran
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment outside Australia
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Arizona
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Indiana
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Leon
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LHospitalet de Llobregat
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Sisli
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Birmingham
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United Kingdom
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Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mirati Therapeutics Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
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Trial website
https://clinicaltrials.gov/study/NCT04613596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Email
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Contact person for public queries
Name
0
0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Address
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Phone
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0
855-907-3286
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Fax
0
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Email
0
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04613596