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
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
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 squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
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.
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 measurable disease per RECIST1.1
Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
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:
Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment
Clinical.Trials@bms.com855-907-3286
Goodyear, Arizona 85395, United States
Cerritos, California 90703, United States
Los Alamitos, California 90720, United States
San Francisco, California 94121, United States
San Francisco, California 94158, United States
Stockton, California 95219, United States
Norwich, Connecticut 06360, United States
Washington D.C., District of Columbia 20010, United States
Fort Myers, Florida 33901, United States
Jacksonville, Florida 32204, United States
Jacksonville, Florida 32256, United States
Tallahassee, Florida 32308, United States
West Palm Beach, Florida 33401, United States
Marietta, Georgia 30060, United States
Lexington, Kentucky 40503, United States
Brighton, Massachusetts 02135, United States
Foxborough, Massachusetts 02035, United States
Methuen, Massachusetts 01844, United States
Milford, Massachusetts 01757, United States
South Weymouth, Massachusetts 02190, United States
Jackson, Mississippi 39202, United States
Omaha, Nebraska 68130, United States
Eugene, Oregon 97401, United States
Pittsburgh, Pennsylvania 15240, United States
Germantown, Tennessee 38138, United States
Nashville, Tennessee 37203, United States
Austin, Texas 78745, United States
Dallas, Texas 75246, United States
Fredericksburg, Texas 78624, United States
Odessa, Texas 79761, United States
Vancouver, Washington 98684, United States
Belgrano, Buenos Aires C1430EGF, Argentina
5491132682903
Ciudad Autonoma de Buenos Aires, Buenos Aires 1426, Argentina
+541151082017
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1427ARO, Argentina
(+54911)4162-5353
Porto Alegre, 91350-200, Argentina
Natal, Rio Grande do Norte 59062-000, Brazil
Barretos, 14784-400, Brazil
Haskovo, 6304, Bulgaria
Sofia, 1431, Bulgaria
Bengbu, Anhui 233000, China
Beijing, Beijing Municipality 100021, China
Beijing, Beijing Municipality 100142, China
Chongqing, Chongqing Municipality 404000, China
Xiamen, Fujian 361003, China
Guangzhou, Guangdong 510120, China
Guangzhou, Guangdong 510515, China
Shenzhen, Guangdong 518000, China
Nanning, Guangxi 530021, China
Harbin, Heilongjiang 150081, China
Zhengzhou, Henan 000000, China
Wuhan, Hubei 430022, China
Nanjing, Jiangsu 210001, China
Changchun, Jilin 130021, China
Xi'an, Shaanxi 710061, China
Shanghai, Shanghai Municipality 200032, China
Hangzhou, Zhejiang 310006, China
Hořovice, 268 31, Czechia
Praha 8 - Liben, 180 81, Czechia
420702154607
Saint-Herblain, 44805, France
Saint-Herblain, 44805, France
Grohansdorf, 22927, Germany
041026012101
Athens, 124 62, Greece
Ahemdabad, 380060, India
9825034353
Bat Galim, 3109601, Israel
Zsfat, 1311001, Israel
+97246828951
Bologna, 40138, Italy
Brescia, 25123, Italy
Genova, 16132, Italy
Milan, 20132, Italy
Nagoya, Chiba 457-8510, Japan
+81526917151
Toon-shi, Ehime 791-0295, Japan
+81-89-960-5994
Nishinomiya-Shi, Hyōgo 663-8501, Japan
Sakai-Shi, Osaka 591-8555, Japan
+81722523021
Hidaka-Shi, Saitama 350-1298, Japan
819014217189
Nankoku-shi, 783-8505, Japan
81888665811
Osaka, 541-8567, Japan
Kielce, 25-734, Poland
Lublin, 20-064, Poland
Poznan, 60-569, Poland
Guimarães, 4835-044, Portugal
Porto, 4099-001, Portugal
Bucharest, 022328, Romania
Las Palmas de Gran Canaria, 35016, Spain
LHospitalet de Llobregat, 08908, Spain
34932607283
Taipei, 23561, Taiwan
Altındağ, 06100, Turkey (Türkiye)
Atakum, 55200, Turkey (Türkiye)
+3623114040
Mamak, 06620, Turkey (Türkiye)
Surrey, GU2 7XX, United Kingdom
441483571122
928-775-9430
520-290-2510
479-872-8130
714-446-5900
562-693-4477
562-997-4070
562-706-6648
415-221-4810x23380
415-502-6959
707-521-3830
209-466-2626
303-430-2700
860-886-8362
239-938-9315
727-398-6661
239-274-9930
904-805-7061
203-530-1728
305-575-7000
412-647-2811
850-696-4000
904-613-4275
813-391-7763
407-933-2775
706-353-2990
4787417145
770-281-5162
847-827-9060
000-000-0000
574-364-2848
8162764700
316-262-4467
859-260-6100
985-875-1202
410-550-1711
617-632-6036
7344536970
9786202020
7813379091
7816244800
601-355-2485
531-329-3667
000-000-0000
301-435-5332
954-267-7700
201-227-6008
518-489-2607
718-405-8404
919-613-2000
513-751-2273
216-286-6505
502-561-7301
855-500-2873
3302686167
541-683-5001
708-327-3180
4126237769
605-322-6900
901-683-0055
615-329-7274
512-427-9400
214-370-1000
000-000-0000
210-595-5300
000-000-0000
281-298-8907
703-280-5390
804-287-3000
503-885-5411
5491138018573
+543414218909
5493416955611
541166936669
61(03)53208500
61882048997
610251242220
+61742266514
61265801820
61242286200
0731766505
4346353831303
0273290044368
4373276763220
+4314040075700
+4319106041242
3238213725
3292468400
+32472565987
+557140097070
554833311553
+551733216600
5551991922412
+359888850330
+359889214157
+359889717793
+35928510866+3592851
+359885295184
7804328248
111-111-1111
6137377700
4169463544
+8618105527755
8618955142161
8613911793771
13701224460
8613521469355
8613896327099
13809500871
13860458889
13560351176
8602062787110
13878106696
13933083069
13904505825
8613938252350
13986252286
8613170419973
13382080588
+8613605812001
13698091288
8615843073215
18940259600
8613572101611
15665878316
+8615963998868
8613601813062
8613501623469
+861087788162
18908178836
18980606625
13857153345
13867622009
+385921101275
+420603268133
420588445657
00420595633400
4574182500
+4535455072
+358505001850
33241352700
33298223578
0231455050
33157022070
33476768708
33555056892
33491324400
33467336135
0389647396
+33624456290
+33676133810
+33142412825
0033369550644
33247473787
+995322516800
+499621381637
+498214002729
+4917615323140
4937133343550
+49221890713962
+4971131032402
496976014187
+49401818828494
02372-9082560
+496312031260
495619803046
+49 8323 9108171
4962213968008
4945150045002
+021618922201xxx2200
+498992704505
+0339139311200000000
0049064198558544
494412291611
302107470960
+302107700220
302105831664
2810392750
+302413502785+302413
00302103501711
302104809852
+302310850906
+85221169283
+85228554542
85235062414
3613913213
3612248600
36209264476
203929250
+36204634328
9820493558
09448866712
6290073778
8891810070
9167760576
+919540946934
+919572240838
9588229594
01-8092010
35314103756
0035314144299
+353 91-524222
353(51)842595
97246495723
+97286400795
97205870406206555727
97226777836
97289441084
+97236973494
390805555442
390512142206
+390119933886
00390557947298
393397231066
+393487469100
+390226434138
+390257489482
390817770291
39498215620
390521702682
39755784185
3335451118
39755784185
+390516225126
00390630156318
390332278558
81529511111
81245471111
81789291151
81227288000
+81958197200
81744223051
0827355681
81762652000
81669293269
81669721181
+6042225209
+6042225770
+60374919191
60124415755
523316063096
525533345856
+528181431112
06-xxxxxxxx
310786541111
+00312410325
31433871318
+31104616161
31887555555
48585844571
48413674315
+504051512
48895322978
4823446300
+48616643300
48506969916
48566101387
+48224312100
351966764837
914000669
+351225512100
351222077500x1729
40723289606
+40372752743
40742206212
40746110096
400256295186
+38163554963
+381642636187+381214
+381693521711
+6563112300
65+65812326578123265
82517970001
+82512407497
82432696015
82532002588
+82319201154
82328901038
82222284190
82230103214
820234103438
821022179216
82312498485
34981178353x292856
34934978925
34935565651
34935460135
34932746077
34669090659
3434928441738
+349133030007332
+34913368000+3491336
+34913307552
+34915494908ext2539
+34913908546
34951290000
34955019273
34963862625
+34663976139
8864220521211210
8864235925253218
886-912777918
8866622699973132
+886223123456+886975
+886-983528981
8862224900882714
+88633281200
+6625766000
+66816845172
+905353067506
00905063509061
+905334318506
905056604536
904223410660
+902323434343+905322
905052137335
+905552414687+905353
905554961787
+905052642353
+905055401630
905327650185
905335720175
05337483275
905324167355
+(44)01214247456
+442034479091
00442071882006
+441614463745