Trial Title:
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
NCT ID:
NCT05853575
Condition:
Advanced Cancer
Metastatic Cancer
Malignant Neoplasm of Lung
Conditions: Official terms:
Neoplasm Metastasis
Neoplasms
Lung Neoplasms
Adagrasib
Conditions: Keywords:
KRAS G12C
Non-small cell lung cancer
Metastatic cancer
NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adagrasib
Description:
KRAS G12C inhibitor
Arm group label:
Adagrasib 400mg BID
Arm group label:
Adagrasib 600mg BID
Other name:
MRTX849
Other name:
Krazati
Summary:
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID
versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
Detailed description:
CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized
between two dosing regimens. The study will evaluate the efficacy of two dosing regimens
of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients
with NSCLC with KRAS G12C mutation and who have received prior treatment with a
platinum-based regimen and immune checkpoint inhibitor therapy.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Are at least 18 years old (or old enough to legally make their own treatment
decisions, according to local laws).
- Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then
spread to other parts of the body) with the KRAS G12C mutation.
- Have had previous treatment with 1) chemotherapy that included a drug called
cisplatin or a drug called carboplatin and 2) a type of drug called an immune
checkpoint inhibitor.
- Have recovered from their prior treatment and blood tests are within a safe range.
Key Exclusion Criteria:
- Have had previous treatment with a drug that targets KRAS G12C.
- Have cancer that can potentially be removed with surgery.
- Patients with brain lesions are not eligible if 1) any untreated brain lesions are >
2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mg
daily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized or
complex partial seizures or neurologic progression/instability due to brain lesions.
- Have certain medical conditions or need to take certain medications that, in the
opinion of a trial doctor, could make it unsafe for them to participate or difficult
to complete the trial assessments, or are pregnant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Providence Medical Foundation
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ian Anderson, Site 101
Facility:
Name:
Local Institution - 106
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 106
Facility:
Name:
Local Institution - 103
Address:
City:
Minneapolis
Zip:
55417
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 103
Facility:
Name:
Local Institution - 105
Address:
City:
Kansas City
Zip:
64128
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 105
Facility:
Name:
Veterans Affairs Medical Center (VAMC) - Durham
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael Kelley, Site 100
Facility:
Name:
VA North Texas Healthcare System/Dallas VA Medical Center
Address:
City:
Dallas
Zip:
75216-7167
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Dowell, Site 102
Facility:
Name:
Local Institution - 179
Address:
City:
Cachoeiro Do Itapemirim
Zip:
29308-065
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 179
Facility:
Name:
Local Institution - 178
Address:
City:
Belo Horizonte
Zip:
30360680
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 178
Facility:
Name:
Local Institution - 177
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 177
Facility:
Name:
Local Institution - 182
Address:
City:
Itajaí
Zip:
88301-220
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 182
Facility:
Name:
Local Institution - 181
Address:
City:
Salvador
Zip:
41950-610
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 181
Facility:
Name:
Local Institution - 175
Address:
City:
São Paulo
Zip:
01509-900
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 175
Facility:
Name:
Local Institution - 527
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Not yet recruiting
Contact:
Last name:
Site 527
Facility:
Name:
Local Institution - 525
Address:
City:
Pula
Zip:
52100
Country:
Croatia
Status:
Not yet recruiting
Contact:
Last name:
Site 525
Facility:
Name:
Hopital Haut-Leveque - Maladies respiratoires
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Contact:
Last name:
Remi Veillon, Site 556
Facility:
Name:
Local Institution - 553
Address:
City:
Saint-Herblain Cedex
Zip:
44800
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 553
Facility:
Name:
Centre Hospitalier Universitaire D' Angers Hôpital Larrey - PNEUMOLOGIE
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Recruiting
Contact:
Last name:
Youssef Oulkhouir, Site 554
Phone:
33231064676
Facility:
Name:
Centre Hospitalier Universitaire de Poitiers
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicolas Isambert, Site 557
Phone:
33549444548
Facility:
Name:
Local Institution - 559
Address:
City:
Grenoble
Zip:
0
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 559
Facility:
Name:
Local Institution - 560
Address:
City:
Villefranche Sur Saone
Zip:
69655
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 560
Facility:
Name:
Centre Hôspitalier de Bretagne Sud - Hôpital du Scorff
Address:
City:
Lorient
Zip:
56322
Country:
France
Status:
Recruiting
Contact:
Last name:
Regine Lamy, Site 552
Facility:
Name:
APHM Hopital Nord
Address:
City:
Marseille
Zip:
13915
Country:
France
Status:
Recruiting
Contact:
Last name:
PASCALE TOMASINI, Site 551
Phone:
111-111-1111
Facility:
Name:
CHU de Nantes - Hôpital Nord Laënnec (HGRL)
Address:
City:
Nantes cedex 1
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Elvire Pons-Tostivint, Site 555
Phone:
+33676133810
Facility:
Name:
Local Institution - 558
Address:
City:
Quimper
Zip:
29000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 558
Facility:
Name:
Hôpital Bégin - Service d'Oncologie
Address:
City:
Saint-Mandé
Zip:
94163
Country:
France
Status:
Recruiting
Contact:
Last name:
Carole Helissey, Site 550
Phone:
33143985319
Facility:
Name:
Local Institution - 577
Address:
City:
Patras
Zip:
265 04
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 577
Facility:
Name:
Local Institution - 575
Address:
City:
Athens
Zip:
11528
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 575
Facility:
Name:
Local Institution - 582
Address:
City:
Athens
Zip:
11528
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 582
Facility:
Name:
Local Institution - 579
Address:
City:
Haidari - Athens
Zip:
12462
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 579
Facility:
Name:
Local Institution - 576
Address:
City:
Thessaloniki
Zip:
54639
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 576
Facility:
Name:
Local Institution - 580
Address:
City:
Panorama
Zip:
552 36
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 580
Facility:
Name:
Local Institution - 581
Address:
City:
Thessaloniki
Zip:
56429
Country:
Greece
Status:
Not yet recruiting
Contact:
Last name:
Site 581
Facility:
Name:
Local Institution - 628
Address:
City:
Tel Aviv-Yafo
Zip:
64239
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 628
Facility:
Name:
Local Institution - 625
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 625
Facility:
Name:
Local Institution - 629
Address:
City:
Haifa
Zip:
31048
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 629
Facility:
Name:
Local Institution - 627
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 627
Facility:
Name:
Local Institution - 626
Address:
City:
Tel-Aviv
Zip:
6423906
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 626
Facility:
Name:
Local Institution - 778
Address:
City:
Pesaro
Zip:
61122
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 778
Facility:
Name:
Local Institution - 780
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 780
Facility:
Name:
Local Institution - 779
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 779
Facility:
Name:
Local Institution - 777
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 777
Facility:
Name:
Local Institution - 775
Address:
City:
Perugia
Zip:
6132
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 775
Facility:
Name:
Local Institution - 776
Address:
City:
Roma
Zip:
144
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 776
Facility:
Name:
National Cancer Center
Address:
City:
Gyeonggido [Kyonggi-do]
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Young Joo 영주 Lee 이, Site 327
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
6351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Se-Hoon 세훈 Lee 이, Site 325
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
8308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eun Joo 은주 Kang 강, Site 326
Facility:
Name:
Gangnam Severance Hospital, Yonsei University Health System
Address:
City:
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Zip:
6273
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seo Young 서영 Lee 이, Site 328
Facility:
Name:
Local Institution - 128
Address:
City:
Tuxtla Gutiérrez
Zip:
29038
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 128
Facility:
Name:
Local Institution - 129
Address:
City:
Cdmx
Zip:
3810
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 129
Facility:
Name:
Local Institution - 127
Address:
City:
Col. Roma
Zip:
0
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 127
Facility:
Name:
Local Institution - 125
Address:
City:
Toluca
Zip:
50090
Country:
Mexico
Status:
Not yet recruiting
Contact:
Last name:
Site 125
Facility:
Name:
Local Institution - 802
Address:
City:
Breda
Zip:
4818 CK
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Site 802
Facility:
Name:
Local Institution - 800
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Site 800
Facility:
Name:
Local Institution - 801
Address:
City:
Nieuwegein
Zip:
3435 CM
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Site 801
Facility:
Name:
Local Institution - 650
Address:
City:
Krakow
Zip:
30-727
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site 650
Facility:
Name:
Local Institution - 651
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site 651
Facility:
Name:
Local Institution - 653
Address:
City:
Lublin
Zip:
20-064
Country:
Poland
Status:
Not yet recruiting
Contact:
Last name:
Site 653
Facility:
Name:
Local Institution - 732
Address:
City:
Cluj-Napoca
Zip:
400641
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 732
Facility:
Name:
Local Institution - 731
Address:
City:
Ovidiu
Zip:
905900
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 731
Facility:
Name:
Local Institution - 729
Address:
City:
Craiova
Zip:
200385
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 729
Facility:
Name:
Local Institution - 734
Address:
City:
Craiova
Zip:
200542
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 734
Facility:
Name:
Local Institution - 730
Address:
City:
Timisoara
Zip:
300166
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 730
Facility:
Name:
Local Institution - 733
Address:
City:
Iasi
Zip:
700106
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 733
Facility:
Name:
Local Institution - 725
Address:
City:
Sibiu
Zip:
550245
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 725
Facility:
Name:
Local Institution - 728
Address:
City:
Suceava
Zip:
720214
Country:
Romania
Status:
Not yet recruiting
Contact:
Last name:
Site 728
Facility:
Name:
Local Institution - 753
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Not yet recruiting
Contact:
Last name:
Site 753
Facility:
Name:
Local Institution - 754
Address:
City:
Nis
Zip:
18000
Country:
Serbia
Status:
Not yet recruiting
Contact:
Last name:
Site 754
Facility:
Name:
Local Institution - 752
Address:
City:
Kragujevac
Zip:
34000
Country:
Serbia
Status:
Not yet recruiting
Contact:
Last name:
Site 752
Facility:
Name:
Complexo Hospitalario Universitario De Santiago
Address:
City:
Santiago De Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jorge Jose Garcia Gonzalez, Site 680
Facility:
Name:
Local Institution - 678
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 678
Facility:
Name:
Local Institution - 676
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 676
Facility:
Name:
Local Institution - 685
Address:
City:
Palma de Mallorca
Zip:
7120
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 685
Facility:
Name:
Local Institution - 684
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 684
Facility:
Name:
Local Institution - 687
Address:
City:
Barcelona
Zip:
8028
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 687
Facility:
Name:
Local Institution - 681
Address:
City:
Barcelona
Zip:
8035
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 681
Facility:
Name:
Local Institution - 683
Address:
City:
Barcelona
Zip:
8041
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 683
Facility:
Name:
Local Institution - 675
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 675
Facility:
Name:
Local Institution - 679
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 679
Facility:
Name:
Hospital Universitario Virgen De La Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
David Vicente Baz, Site 682
Phone:
34955008932955008932
Facility:
Name:
Local Institution - 677
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 677
Facility:
Name:
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsuing City
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chien-Hao 建豪 Lai 賴, Site 352
Facility:
Name:
China Medical University Hospital - Internal Medicine
Address:
City:
Taichung City
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Te-Chun 德椿 Hsia 夏, Site 350
Facility:
Name:
Chung Shan Medical University Hospital
Address:
City:
Taichung City
Zip:
40201
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Gee-Chen 基晟 Chang 張, Site 353
Facility:
Name:
Local Institution - 355
Address:
City:
Taichung City
Zip:
40705
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
Site 355
Facility:
Name:
Local Institution - 377
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Not yet recruiting
Contact:
Last name:
Site 377
Facility:
Name:
Local Institution - 376
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Status:
Not yet recruiting
Contact:
Last name:
Site 376
Facility:
Name:
Local Institution - 375
Address:
City:
Khon Kaen
Zip:
40002
Country:
Thailand
Status:
Not yet recruiting
Contact:
Last name:
Site 375
Facility:
Name:
Local Institution - 378
Address:
City:
Songkhla
Zip:
90110
Country:
Thailand
Status:
Not yet recruiting
Contact:
Last name:
Site 378
Facility:
Name:
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Address:
City:
Ankara
Zip:
6010
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Nuri Karadurmus, Site 702
Phone:
905366401020
Facility:
Name:
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Address:
City:
Ankara
Zip:
6200
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Cengiz Karacin, Site 704
Facility:
Name:
Memorial Ankara Hastanesi Tibbi Onkoloji
Address:
City:
Ankara
Zip:
6520
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Umut Demirci, Site 705
Facility:
Name:
Ankara Liv Hospital Tibbi Onkoloji
Address:
City:
Ankara
Zip:
6680
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Saadettin Kilickap, Site 701
Phone:
+905056604536
Facility:
Name:
Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi
Address:
City:
Ankara
Zip:
6800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mehmet Ali Nahit Sendur, Site 706
Facility:
Name:
Trakya Univ Hastanesi Ic Hastal
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Muhammet Hacioglu, Site 700
Phone:
+905334364678
Facility:
Name:
Local Institution - 709
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site 709
Facility:
Name:
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mahmut Gumus, Site 707
Phone:
00905063509061
Facility:
Name:
Istanbul Onkoloji Hastanesi Tibbi Onkoloji
Address:
City:
Istanbul
Zip:
34846
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Ilker Okten, Site 710
Phone:
+905334399009
Facility:
Name:
Local Institution - 708
Address:
City:
Izmir
Zip:
35100
Country:
Turkey
Status:
Not yet recruiting
Contact:
Last name:
Site 708
Start date:
February 16, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Mirati Therapeutics Inc.
Agency class:
Industry
Source:
Mirati Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853575
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.BMSClinicalTrials.com
