Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
19/11/2024

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
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
Secondary ID [1] 0 0
CA239-0009
Secondary ID [2] 0 0
CA239-0009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Non-Small Cell Lung Cancer 0 0
Metastatic Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Timepoint [1] 0 0
22 months
Primary outcome [2] 0 0
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Phase 2: To characterize the safety and tolerability of study treatments in selected populations
Timepoint [1] 0 0
22 months
Secondary outcome [2] 0 0
Phase 2: Duration of Response
Timepoint [2] 0 0
22 months
Secondary outcome [3] 0 0
Phase 2: Progression Free Survival
Timepoint [3] 0 0
22 months
Secondary outcome [4] 0 0
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Timepoint [5] 0 0
22 months
Secondary outcome [6] 0 0
Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
Timepoint [6] 0 0
22 months
Secondary outcome [7] 0 0
Phase 3: To evaluate the safety and tolerability in the study population
Timepoint [7] 0 0
36 months
Secondary outcome [8] 0 0
Phase 3: To evaluate the PK of adagrasib administered in the study population
Timepoint [8] 0 0
36 months
Secondary outcome [9] 0 0
Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
Timepoint [9] 0 0
36 months
Secondary outcome [10] 0 0
Phase 3: Progression Free Survival per RECIST 1.1 by Investigator
Timepoint [10] 0 0
36 months
Secondary outcome [11] 0 0
Phase 3: Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR
Timepoint [11] 0 0
36 months
Secondary outcome [12] 0 0
Phase 3: Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR
Timepoint [12] 0 0
36 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2029
Actual
Sample size
Target
806
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Regional Integrated Cancer Center - Ballarat
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Local Institution - 007-004 - Clayton
Recruitment hospital [4] 0 0
Local Institution - 007-006 - Garran
Recruitment hospital [5] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
Argentina
State/province [37] 0 0
Buenos Aires
Country [38] 0 0
Argentina
State/province [38] 0 0
Porto Alegre
Country [39] 0 0
Argentina
State/province [39] 0 0
Rio Cuarto
Country [40] 0 0
Austria
State/province [40] 0 0
Klagenfurt Am Woerthersee
Country [41] 0 0
Austria
State/province [41] 0 0
Linz
Country [42] 0 0
Austria
State/province [42] 0 0
Wien
Country [43] 0 0
Belgium
State/province [43] 0 0
Edegem
Country [44] 0 0
Belgium
State/province [44] 0 0
Gent
Country [45] 0 0
Belgium
State/province [45] 0 0
Hasselt
Country [46] 0 0
Belgium
State/province [46] 0 0
Roeselare
Country [47] 0 0
Brazil
State/province [47] 0 0
Rio Grande Do Sul
Country [48] 0 0
Brazil
State/province [48] 0 0
Barretos
Country [49] 0 0
Brazil
State/province [49] 0 0
Ijui
Country [50] 0 0
Brazil
State/province [50] 0 0
Rio de Janeiro
Country [51] 0 0
Brazil
State/province [51] 0 0
Sao Jose Do Rio Preto
Country [52] 0 0
Brazil
State/province [52] 0 0
Sao Paolo
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Gabrovo
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Haskovo
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Plovdiv
Country [56] 0 0
Bulgaria
State/province [56] 0 0
Sofia
Country [57] 0 0
Bulgaria
State/province [57] 0 0
Vratsa
Country [58] 0 0
Canada
State/province [58] 0 0
Alberta
Country [59] 0 0
Canada
State/province [59] 0 0
British Columbia
Country [60] 0 0
Canada
State/province [60] 0 0
Ontario
Country [61] 0 0
Canada
State/province [61] 0 0
Quebec
Country [62] 0 0
Chile
State/province [62] 0 0
Santiago
Country [63] 0 0
Chile
State/province [63] 0 0
Temuco
Country [64] 0 0
Colombia
State/province [64] 0 0
Medellin
Country [65] 0 0
Colombia
State/province [65] 0 0
Monteria
Country [66] 0 0
Croatia
State/province [66] 0 0
Pula
Country [67] 0 0
Croatia
State/province [67] 0 0
Rijeka
Country [68] 0 0
Croatia
State/province [68] 0 0
Zagreb
Country [69] 0 0
Czechia
State/province [69] 0 0
Horovice
Country [70] 0 0
Czechia
State/province [70] 0 0
Olomouc
Country [71] 0 0
Czechia
State/province [71] 0 0
Ostrava
Country [72] 0 0
Czechia
State/province [72] 0 0
Praha 2
Country [73] 0 0
Czechia
State/province [73] 0 0
Praha 8 - Liben
Country [74] 0 0
Denmark
State/province [74] 0 0
Odense
Country [75] 0 0
Denmark
State/province [75] 0 0
Soenderborg
Country [76] 0 0
Denmark
State/province [76] 0 0
Vejle
Country [77] 0 0
Finland
State/province [77] 0 0
Tampere
Country [78] 0 0
France
State/province [78] 0 0
Brest
Country [79] 0 0
France
State/province [79] 0 0
Creteil
Country [80] 0 0
France
State/province [80] 0 0
La Tronche
Country [81] 0 0
France
State/province [81] 0 0
Marseille
Country [82] 0 0
France
State/province [82] 0 0
Montpellier
Country [83] 0 0
France
State/province [83] 0 0
Mulhouse
Country [84] 0 0
France
State/province [84] 0 0
Paris cedex 05
Country [85] 0 0
France
State/province [85] 0 0
Saint Herblain
Country [86] 0 0
France
State/province [86] 0 0
Strasbourg cedex
Country [87] 0 0
France
State/province [87] 0 0
Tours Cedex 9
Country [88] 0 0
France
State/province [88] 0 0
Villejuif
Country [89] 0 0
Georgia
State/province [89] 0 0
Batumi
Country [90] 0 0
Georgia
State/province [90] 0 0
Tbilisi
Country [91] 0 0
Germany
State/province [91] 0 0
Bayern
Country [92] 0 0
Germany
State/province [92] 0 0
Chemnitz
Country [93] 0 0
Germany
State/province [93] 0 0
Esslingen
Country [94] 0 0
Germany
State/province [94] 0 0
Frankfurt am Main
Country [95] 0 0
Germany
State/province [95] 0 0
Giessen
Country [96] 0 0
Germany
State/province [96] 0 0
Grohansdorf
Country [97] 0 0
Germany
State/province [97] 0 0
Heidelberg
Country [98] 0 0
Germany
State/province [98] 0 0
Heilbronn
Country [99] 0 0
Germany
State/province [99] 0 0
Hemer
Country [100] 0 0
Germany
State/province [100] 0 0
Jena
Country [101] 0 0
Germany
State/province [101] 0 0
Kassel
Country [102] 0 0
Germany
State/province [102] 0 0
Kempten
Country [103] 0 0
Germany
State/province [103] 0 0
Lubeck
Country [104] 0 0
Germany
State/province [104] 0 0
Mainz
Country [105] 0 0
Germany
State/province [105] 0 0
Munchen
Country [106] 0 0
Germany
State/province [106] 0 0
Offenbach
Country [107] 0 0
Germany
State/province [107] 0 0
Oldenburg
Country [108] 0 0
Greece
State/province [108] 0 0
Attiki
Country [109] 0 0
Greece
State/province [109] 0 0
Athens
Country [110] 0 0
Greece
State/province [110] 0 0
Heraklion
Country [111] 0 0
Greece
State/province [111] 0 0
Larissa
Country [112] 0 0
Greece
State/province [112] 0 0
Peiraias
Country [113] 0 0
Hong Kong
State/province [113] 0 0
Chai Wan
Country [114] 0 0
Hong Kong
State/province [114] 0 0
Hong Kong
Country [115] 0 0
Hong Kong
State/province [115] 0 0
Kowloon
Country [116] 0 0
Hungary
State/province [116] 0 0
Budapest
Country [117] 0 0
Hungary
State/province [117] 0 0
Farkasgyepu
Country [118] 0 0
Hungary
State/province [118] 0 0
Gyongyos
Country [119] 0 0
Hungary
State/province [119] 0 0
Tatabanya
Country [120] 0 0
Hungary
State/province [120] 0 0
Torokbalint
Country [121] 0 0
India
State/province [121] 0 0
Mangalore
Country [122] 0 0
India
State/province [122] 0 0
Mysore
Country [123] 0 0
India
State/province [123] 0 0
Patna
Country [124] 0 0
India
State/province [124] 0 0
Rajkot
Country [125] 0 0
Ireland
State/province [125] 0 0
Cork
Country [126] 0 0
Ireland
State/province [126] 0 0
Dublin
Country [127] 0 0
Ireland
State/province [127] 0 0
Galway
Country [128] 0 0
Ireland
State/province [128] 0 0
Limerick
Country [129] 0 0
Ireland
State/province [129] 0 0
Waterford
Country [130] 0 0
Israel
State/province [130] 0 0
Afula
Country [131] 0 0
Israel
State/province [131] 0 0
Bat Galim
Country [132] 0 0
Israel
State/province [132] 0 0
Beer Sheva
Country [133] 0 0
Israel
State/province [133] 0 0
Holon
Country [134] 0 0
Israel
State/province [134] 0 0
Jerusalem
Country [135] 0 0
Israel
State/province [135] 0 0
Rehovot
Country [136] 0 0
Israel
State/province [136] 0 0
Tel Aviv
Country [137] 0 0
Israel
State/province [137] 0 0
Zsfat
Country [138] 0 0
Italy
State/province [138] 0 0
Aviano
Country [139] 0 0
Italy
State/province [139] 0 0
Bari
Country [140] 0 0
Italy
State/province [140] 0 0
Bologna
Country [141] 0 0
Italy
State/province [141] 0 0
Brescia
Country [142] 0 0
Italy
State/province [142] 0 0
Candiolo
Country [143] 0 0
Italy
State/province [143] 0 0
Firenze
Country [144] 0 0
Italy
State/province [144] 0 0
Genova
Country [145] 0 0
Italy
State/province [145] 0 0
Meldola
Country [146] 0 0
Italy
State/province [146] 0 0
Milano
Country [147] 0 0
Italy
State/province [147] 0 0
Milan
Country [148] 0 0
Italy
State/province [148] 0 0
Monza
Country [149] 0 0
Italy
State/province [149] 0 0
Napoli
Country [150] 0 0
Italy
State/province [150] 0 0
Padova
Country [151] 0 0
Italy
State/province [151] 0 0
Parma
Country [152] 0 0
Italy
State/province [152] 0 0
Perugia
Country [153] 0 0
Italy
State/province [153] 0 0
Pesaro
Country [154] 0 0
Italy
State/province [154] 0 0
Ravenna
Country [155] 0 0
Italy
State/province [155] 0 0
Roma
Country [156] 0 0
Italy
State/province [156] 0 0
Rozzano
Country [157] 0 0
Italy
State/province [157] 0 0
Varese
Country [158] 0 0
Japan
State/province [158] 0 0
Kanagawa
Country [159] 0 0
Japan
State/province [159] 0 0
Osaka
Country [160] 0 0
Japan
State/province [160] 0 0
Fukushima-Shi
Country [161] 0 0
Korea, Republic of
State/province [161] 0 0
Busan
Country [162] 0 0
Korea, Republic of
State/province [162] 0 0
Cheongju-si
Country [163] 0 0
Korea, Republic of
State/province [163] 0 0
Daegu
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Goyang-si
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Jung-Gu
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Seoul
Country [167] 0 0
Korea, Republic of
State/province [167] 0 0
Suwon-Si
Country [168] 0 0
Malaysia
State/province [168] 0 0
Johor
Country [169] 0 0
Malaysia
State/province [169] 0 0
Penang
Country [170] 0 0
Malaysia
State/province [170] 0 0
Selangor
Country [171] 0 0
Malaysia
State/province [171] 0 0
Kuala Lumpur
Country [172] 0 0
Mexico
State/province [172] 0 0
Distrito Federal
Country [173] 0 0
Mexico
State/province [173] 0 0
Jalisco
Country [174] 0 0
Mexico
State/province [174] 0 0
Monterrey
Country [175] 0 0
Netherlands
State/province [175] 0 0
Amsterdam
Country [176] 0 0
Netherlands
State/province [176] 0 0
Den Haag
Country [177] 0 0
Netherlands
State/province [177] 0 0
Dordrecht
Country [178] 0 0
Netherlands
State/province [178] 0 0
Harderwijk
Country [179] 0 0
Netherlands
State/province [179] 0 0
Nijmegen
Country [180] 0 0
Netherlands
State/province [180] 0 0
Rotterdam
Country [181] 0 0
Netherlands
State/province [181] 0 0
Utrecht
Country [182] 0 0
Netherlands
State/province [182] 0 0
Zwolle
Country [183] 0 0
Norway
State/province [183] 0 0
Oslo
Country [184] 0 0
Peru
State/province [184] 0 0
La Libertad
Country [185] 0 0
Peru
State/province [185] 0 0
Lima
Country [186] 0 0
Peru
State/province [186] 0 0
Arequipa
Country [187] 0 0
Peru
State/province [187] 0 0
Cusco
Country [188] 0 0
Philippines
State/province [188] 0 0
Bacolod City
Country [189] 0 0
Philippines
State/province [189] 0 0
Makati City
Country [190] 0 0
Philippines
State/province [190] 0 0
Molo
Country [191] 0 0
Philippines
State/province [191] 0 0
Quezon City
Country [192] 0 0
Poland
State/province [192] 0 0
Gdansk
Country [193] 0 0
Poland
State/province [193] 0 0
Kielce
Country [194] 0 0
Poland
State/province [194] 0 0
Krakow
Country [195] 0 0
Poland
State/province [195] 0 0
Lublin
Country [196] 0 0
Poland
State/province [196] 0 0
Olsztyn
Country [197] 0 0
Poland
State/province [197] 0 0
Otwock
Country [198] 0 0
Poland
State/province [198] 0 0
Poznan
Country [199] 0 0
Poland
State/province [199] 0 0
Skorzewo
Country [200] 0 0
Poland
State/province [200] 0 0
Torun
Country [201] 0 0
Poland
State/province [201] 0 0
Warszawa
Country [202] 0 0
Portugal
State/province [202] 0 0
Coimbra
Country [203] 0 0
Portugal
State/province [203] 0 0
Guimaraes
Country [204] 0 0
Portugal
State/province [204] 0 0
Lisboa
Country [205] 0 0
Portugal
State/province [205] 0 0
Lisbon
Country [206] 0 0
Portugal
State/province [206] 0 0
Porto
Country [207] 0 0
Portugal
State/province [207] 0 0
Vila Nova de Gaia
Country [208] 0 0
Romania
State/province [208] 0 0
Cluj-Napoca
Country [209] 0 0
Romania
State/province [209] 0 0
Timisoara
Country [210] 0 0
Serbia
State/province [210] 0 0
Belgrade
Country [211] 0 0
Serbia
State/province [211] 0 0
Sremska Kamenica
Country [212] 0 0
Singapore
State/province [212] 0 0
Singapore
Country [213] 0 0
South Africa
State/province [213] 0 0
Eastern Cape
Country [214] 0 0
South Africa
State/province [214] 0 0
Gauteng
Country [215] 0 0
Spain
State/province [215] 0 0
Navarre
Country [216] 0 0
Spain
State/province [216] 0 0
A Coruna
Country [217] 0 0
Spain
State/province [217] 0 0
Badalona
Country [218] 0 0
Spain
State/province [218] 0 0
Barcelona
Country [219] 0 0
Spain
State/province [219] 0 0
Bilbao
Country [220] 0 0
Spain
State/province [220] 0 0
Burgos
Country [221] 0 0
Spain
State/province [221] 0 0
Jerez de la Frontera
Country [222] 0 0
Spain
State/province [222] 0 0
Las Palmas de Gran Canaria
Country [223] 0 0
Spain
State/province [223] 0 0
Leon
Country [224] 0 0
Spain
State/province [224] 0 0
LHospitalet de Llobregat
Country [225] 0 0
Spain
State/province [225] 0 0
Madrid
Country [226] 0 0
Spain
State/province [226] 0 0
Malaga
Country [227] 0 0
Spain
State/province [227] 0 0
Santander
Country [228] 0 0
Spain
State/province [228] 0 0
Santiago de Compostela
Country [229] 0 0
Spain
State/province [229] 0 0
Sevilla
Country [230] 0 0
Spain
State/province [230] 0 0
Valencia
Country [231] 0 0
Sweden
State/province [231] 0 0
Gavle
Country [232] 0 0
Switzerland
State/province [232] 0 0
Sankt Gallen
Country [233] 0 0
Switzerland
State/province [233] 0 0
Villars-sur-Glane
Country [234] 0 0
Taiwan
State/province [234] 0 0
Taichung City
Country [235] 0 0
Taiwan
State/province [235] 0 0
Taichung
Country [236] 0 0
Taiwan
State/province [236] 0 0
Tainan City
Country [237] 0 0
Taiwan
State/province [237] 0 0
Tainan
Country [238] 0 0
Taiwan
State/province [238] 0 0
Taipei City
Country [239] 0 0
Taiwan
State/province [239] 0 0
Taoyuan
Country [240] 0 0
Thailand
State/province [240] 0 0
Krung Thep Maha Nakhon
Country [241] 0 0
Turkey
State/province [241] 0 0
Alanya
Country [242] 0 0
Turkey
State/province [242] 0 0
Altindag
Country [243] 0 0
Turkey
State/province [243] 0 0
Ankara
Country [244] 0 0
Turkey
State/province [244] 0 0
Antalya
Country [245] 0 0
Turkey
State/province [245] 0 0
Bahcelievler
Country [246] 0 0
Turkey
State/province [246] 0 0
Bornova
Country [247] 0 0
Turkey
State/province [247] 0 0
Cankaya
Country [248] 0 0
Turkey
State/province [248] 0 0
Edirne
Country [249] 0 0
Turkey
State/province [249] 0 0
Istanbul
Country [250] 0 0
Turkey
State/province [250] 0 0
Izmir
Country [251] 0 0
Turkey
State/province [251] 0 0
Kocaeli
Country [252] 0 0
Turkey
State/province [252] 0 0
Malatya
Country [253] 0 0
Turkey
State/province [253] 0 0
Mamak
Country [254] 0 0
Turkey
State/province [254] 0 0
Sisli
Country [255] 0 0
United Kingdom
State/province [255] 0 0
Birmingham
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Edinburgh
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Kent
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Leicester
Country [259] 0 0
United Kingdom
State/province [259] 0 0
London
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Manchester
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04613596
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04613596