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Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Primary Purpose

Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Adagrasib
Adagrasib
Adagrasib
Adagrasib
Pembrolizumab
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring KRAS G12C, Non-small cell lung cancer, NSCLC, Metastatic Non-Small Cell Lung Cancer, Adagrasib, Krazati, TPS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

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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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Phase 2 Cohort 1a: PD-L1 TPS <1%

Phase 2 Cohort 1b: PD-L1 TPS <1%

Phase 2 Cohort 2: PD-L1 TPS ≥1%

Phase 3 Cohort 3 Investigational Arm

Phase 3 Cohort 4 Comparator Arm

Arm Description

Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab

Cohort 1b: Adagrasib BID monotherapy

Cohort 2: Adagrasib BID in combination with pembrolizumab

Adagrasib BID in combination with pembrolizumab

Pembrolizumab

Outcomes

Primary Outcome Measures

Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
Progression Free Survival by blinded independent central review (BICR)

Secondary Outcome Measures

Phase 2: To characterize the safety and tolerability of study treatments in selected populations
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Phase 2: Duration of Response
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.
Phase 2: Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
1-Year Survival rate
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Overall Survival (OS)
Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
Phase 3: To evaluate the safety and tolerability in the study population
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Phase 3: To evaluate the PK of adagrasib administered in the study population
Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
Patient Reported Outcomes to measure quality of life
Phase 3: Overall Survival
Defined as time from date of first study treatment to date of death due to any cause
Phase 3: Progression Free Survival by Investigator
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Phase 3: 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.

Full Information

First Posted
October 28, 2020
Last Updated
October 5, 2023
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04613596
Brief Title
Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Official Title
A Phase 2 Trial of MRTX849 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
October 31, 2028 (Anticipated)
Study Completion Date
October 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score <1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS >=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and comparator arms. Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and tolerability, adagrasib PK, PROs, and correlative genomic biomarkers for the combination regimen in the study population. MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Keywords
KRAS G12C, Non-small cell lung cancer, NSCLC, Metastatic Non-Small Cell Lung Cancer, Adagrasib, Krazati, TPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
MRTX849 Monotherapy, MRTX849 in Combination with Pembrolizumab and Pembrolizumab alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
751 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Cohort 1a: PD-L1 TPS <1%
Arm Type
Experimental
Arm Description
Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
Arm Title
Phase 2 Cohort 1b: PD-L1 TPS <1%
Arm Type
Experimental
Arm Description
Cohort 1b: Adagrasib BID monotherapy
Arm Title
Phase 2 Cohort 2: PD-L1 TPS ≥1%
Arm Type
Experimental
Arm Description
Cohort 2: Adagrasib BID in combination with pembrolizumab
Arm Title
Phase 3 Cohort 3 Investigational Arm
Arm Type
Experimental
Arm Description
Adagrasib BID in combination with pembrolizumab
Arm Title
Phase 3 Cohort 4 Comparator Arm
Arm Type
Active Comparator
Arm Description
Pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Adagrasib
Other Intervention Name(s)
Pembrolizumab
Intervention Description
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
Intervention Type
Drug
Intervention Name(s)
Adagrasib
Intervention Description
Adagrasib 600 mg BID monotherapy (Cohort 1b)
Intervention Type
Drug
Intervention Name(s)
Adagrasib
Other Intervention Name(s)
Pembrolizumab
Intervention Description
adagrasib 400 mg BID in combination with pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Adagrasib
Other Intervention Name(s)
Pemrolizumab
Intervention Description
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab 200 mg IV Q3W
Primary Outcome Measure Information:
Title
Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Description
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time Frame
22 months
Title
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
Description
Progression Free Survival by blinded independent central review (BICR)
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Phase 2: To characterize the safety and tolerability of study treatments in selected populations
Description
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Time Frame
22 months
Title
Phase 2: Duration of Response
Description
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
22 months
Title
Phase 2: Progression Free Survival
Description
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time Frame
22 months
Title
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Description
1-Year Survival rate
Time Frame
12 months
Title
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Description
Overall Survival (OS)
Time Frame
22 months
Title
Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
Description
Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
Time Frame
22 months
Title
Phase 3: To evaluate the safety and tolerability in the study population
Description
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.
Time Frame
36 months
Title
Phase 3: To evaluate the PK of adagrasib administered in the study population
Description
Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations
Time Frame
36 months
Title
Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
Description
Patient Reported Outcomes to measure quality of life
Time Frame
36 months
Title
Phase 3: Overall Survival
Description
Defined as time from date of first study treatment to date of death due to any cause
Time Frame
36 months
Title
Phase 3: Progression Free Survival by Investigator
Description
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Time Frame
36 months
Title
Phase 3: Duration of Response (DOR)
Description
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
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: No evidence of brain metastases Untreated brain metastases not needing immediate local therapy Previously treated brain metastases not needing immediate local therapy 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: Any untreated brain lesions > 1.0 cm in size Any brainstem lesions 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Chao, MD
Organizational Affiliation
Mirati Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Prescott Valley
State/Province
Arizona
ZIP/Postal Code
86314
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United States
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Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
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United States
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Research Site
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Springdale
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Arkansas
ZIP/Postal Code
72762
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United States
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Research Site
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Anaheim
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California
ZIP/Postal Code
92805
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United States
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Long Beach
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California
ZIP/Postal Code
90806
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United States
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Los Alamitos
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California
ZIP/Postal Code
90720
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94121
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United States
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San Francisco
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California
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94143
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United States
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Santa Rosa
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California
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95403
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United States
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Stockton
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California
ZIP/Postal Code
95219
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United States
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Whittier
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California
ZIP/Postal Code
90602
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United States
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Research Site
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Lone Tree
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Colorado
ZIP/Postal Code
80124
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United States
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Norwich
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Connecticut
ZIP/Postal Code
06360
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United States
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Bay Pines
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Florida
ZIP/Postal Code
33744
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United States
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Fort Myers
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Florida
ZIP/Postal Code
33901
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United States
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Research Site
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Fort Myers
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Florida
ZIP/Postal Code
33907
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United States
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Jacksonville
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Florida
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32204
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United States
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Jacksonville
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Florida
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32256
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United States
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Miami
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Florida
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33125
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United States
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Orlando
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Florida
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32804
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United States
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Tallahassee
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Florida
ZIP/Postal Code
32308
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United States
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West Palm Beach
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Florida
ZIP/Postal Code
33401
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United States
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Athens
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Georgia
ZIP/Postal Code
30607
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United States
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Chicago
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Illinois
ZIP/Postal Code
60637
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United States
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Niles
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Illinois
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60714
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United States
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Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
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United States
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Goshen
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Indiana
ZIP/Postal Code
46580
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United States
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Wichita
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Kansas
ZIP/Postal Code
67460
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United States
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Research Site
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Lexington
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Kentucky
ZIP/Postal Code
40503
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United States
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Research Site
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Covington
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Louisiana
ZIP/Postal Code
70433
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21287
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United States
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Boston
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Massachusetts
ZIP/Postal Code
02215
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United States
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Research Site
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Burnsville
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Minnesota
ZIP/Postal Code
55337
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United States
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Jackson
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Mississippi
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39202
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United States
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Omaha
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Nebraska
ZIP/Postal Code
68130
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United States
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Las Vegas
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Nevada
ZIP/Postal Code
89102
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United States
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East Brunswick
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New Jersey
ZIP/Postal Code
08816
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United States
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Hackensack
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New Jersey
ZIP/Postal Code
07601
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United States
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Albany
State/Province
New York
ZIP/Postal Code
12206
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United States
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Research Site
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Bronx
State/Province
New York
ZIP/Postal Code
10467
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United States
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Research Site
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Durham
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North Carolina
ZIP/Postal Code
27710
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United States
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Research Site
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Cincinnati
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Ohio
ZIP/Postal Code
45242
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United States
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Cleveland
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Ohio
ZIP/Postal Code
44106
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United States
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Research Site
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Columbus
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Ohio
ZIP/Postal Code
43219
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United States
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Research Site
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Kettering
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Ohio
ZIP/Postal Code
45429
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United States
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Research Site
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Eugene
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Oregon
ZIP/Postal Code
97401
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United States
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Research Site
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Salem
State/Province
Oregon
ZIP/Postal Code
97301
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United States
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Research Site
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Sioux Falls
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South Dakota
ZIP/Postal Code
57105
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United States
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Research Site
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Germantown
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Tennessee
ZIP/Postal Code
38138
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United States
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Research Site
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Nashville
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Tennessee
ZIP/Postal Code
37203
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United States
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Research Site
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Arlington
State/Province
Texas
ZIP/Postal Code
76012
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United States
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Research Site
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Austin
State/Province
Texas
ZIP/Postal Code
78745
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United States
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Research Site
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Bedford
State/Province
Texas
ZIP/Postal Code
76022
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United States
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Research Site
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Dallas
State/Province
Texas
ZIP/Postal Code
75246
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United States
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Research Site
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
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United States
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Research Site
City
Fredericksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
Facility Name
Research Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Research Site
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
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Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
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Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
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United States
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Research Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Research Site
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Research Site
City
Klagenfurt
State/Province
Carinthia
ZIP/Postal Code
9020
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Research Site
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Facility Name
Research Site
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Gent
State/Province
Vlaams Brabant
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research site
City
Hořovice
State/Province
Central Bohemian
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
703 00
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Research Site
City
Esslingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73730
Country
Germany
Facility Name
Research Site
City
Kempten
State/Province
Bavaria
ZIP/Postal Code
87439
Country
Germany
Facility Name
Research Site
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
Facility Name
Research Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
Research Site
City
Großhansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Research Site
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Research Site
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Research Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Research Site
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Research Site
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Research Site
City
Reẖovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Research Site
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Research Site
City
Meldola
State/Province
Forli-Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Research Site
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Research Site
City
Incheon
State/Province
Gyeonggi-do
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Research Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Research Site
City
Gdańsk
State/Province
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Research Site
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Research Site
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Research Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Lisbon
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Research Site
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Research Site
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Research Site
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
Research Site
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Research Site
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Surrey
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase 2 Trial of MRTX849 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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