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

Advanced Non-Small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613596
• Other study ID #: CA239-0009
• Secondary ID: CA239-0009849-00
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2, 2020
• Est. completion date: October 31, 2029

Study information

• Verified date: June 2024
• Source: Mirati Therapeutics Inc.
• Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 806
• Est. completion date: October 31, 2029
• Est. primary completion date: October 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-Small Cell Lung Cancer

Intervention

Drug:
• Adagrasib
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
• Adagrasib
Adagrasib 600 mg BID monotherapy (Cohort 1b)
• Adagrasib
adagrasib 400 mg BID in combination with pembrolizumab
• Adagrasib
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
• Pembrolizumab
Pembrolizumab 200 mg IV Q3W

Locations

Country	Name	City	State
Argentina	Local Institution - Unk053	Buenos Aires
Argentina	Local Institution - Unk043	Ciudad Autonoma De Buenos Aires	Buenos Aires
Argentina	Local Institution - Unk033	Porto Alegre
Argentina	Local Institution - Unk020	Rio Cuarto
Australia	Ballarat Regional Integrated Cancer Center	Ballarat
Australia	Flinders Medical Centre	Bedford Park
Australia	Local Institution - 007-004	Clayton
Australia	Local Institution - 007-006	Garran
Australia	Cancer Care Wollongong	Wollongong
Australia	Princess Alexandra Hospital	Woolloongabba
Austria	Klinikum Klagenfurt Am Worthersee	Klagenfurt Am Woerthersee
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Wiener Gesundheitsverbund - Klinik Floridsdorf	Wien
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Algemeen Ziekenhuis Maria Middelares	Gent
Belgium	Jessa Ziekenhuis - Campus Virga Jesse	Hasselt
Belgium	Local Institution - 007-152	Roeselare
Brazil	Local Institution - Unk060	Barretos
Brazil	Local Institution - Unk002	Ijui
Brazil	Local Institution - Unk050	Lajeado	Rio Grande Do Sul
Brazil	Local Institution - Unk015	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - Unk003	Rio de Janeiro
Brazil	Local Institution - Unk019	Sao Jose Do Rio Preto
Brazil	Local Institution - Unk074	Sao Paolo
Bulgaria	Local Institution - 007-380	Gabrovo
Bulgaria	Local Institution - 007-378	Haskovo
Bulgaria	Local Institution - 007-377	Plovdiv
Bulgaria	Local Institution - 007-379	Sofia
Bulgaria	Local Institution - 007-376	Vratsa
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Local Institution - 007-489	London	Ontario
Canada	Local Institution - 007-490	Montreal	Quebec
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver	Vancouver	British Columbia
Chile	Local Institution - Unk028	Santiago
Chile	Local Institution - Unk073	Temuco
Colombia	Local Institution - Unk021	Medellin
Colombia	Local Institution - Unk027	Monteria
Czechia	Multiscan - Ambulance klinicke onkologie se stacionarem - Horovice	Horovice
Czechia	Fakultni Nemocnice Olomouc	Olomouc
Czechia	Nemocnice AGEL Ostrava-Vitkovice	Ostrava
Czechia	Local Institution - 007-163	Praha 2
Czechia	Fakultni nemocnice Bulovka	Praha 8 - Liben
France	Local Institution - 007-194	Brest
France	Local Institution - 007-190	Creteil
France	Local Institution - 007-683	La Tronche
France	Local Institution - 007-199	Marseille
France	Local Institution - 007-200	Montpellier
France	Local Institution - 007-666	Mulhouse
France	Local Institution - 007-664	Paris cedex 05
France	Local Institution - 007-198	Saint Herblain
France	Local Institution - 007-684	Strasbourg cedex
France	Local Institution - 007-209	Tours Cedex 9
France	Local Institution - 007-202	Villejuif
Georgia	Local Institution - 007-790	Batumi
Georgia	Local Institution - 007-063	Tbilisi
Georgia	Local Institution - 007-065	Tbilisi
Georgia	Local Institution - 007-789	Tbilisi
Georgia	Local Institution - 007-795	Tbilisi
Germany	Local Institution - 007-2215	Chemnitz
Germany	Klinikum Esslingen	Esslingen
Germany	Krankenhaus Nordwest	Frankfurt am Main
Germany	Local Institution - 007-674	Giessen
Germany	LungenClinic Grosshansdorf	Grohansdorf
Germany	Local Institution - 007-677	Heidelberg
Germany	Local Institution - 007-673	Heilbronn
Germany	Lungenklinik Hemer	Hemer
Germany	Local Institution - 007-225	Jena
Germany	Klinikum Kassel	Kassel
Germany	Klinikverbund Allgau - Klinikum Kempten	Kempten
Germany	Universitatsklinikum Schleswig-Holstein - Campus Lubeck	Lubeck
Germany	Local Institution - 007-223	Mainz
Germany	Munchen Klinik Bogenhausen	Munchen
Germany	Sana Klinikum Offenbach	Offenbach
Germany	Pius-Hospital Oldenburg	Oldenburg
Greece	Local Institution - 007-236	Athens
Greece	Local Institution - 007-502	Athens
Greece	Local Institution - 007-238	Heraklion
Greece	Local Institution - 007-235	Larissa
Greece	Local Institution - 007-234	Peiraias
Hungary	Orszagos Koranyi Pulmonologiai Intezet	Budapest
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Semmelweis Egyetem - Pulmonologiai Klinika	Budapest
Hungary	Local Institution - 007-058	Farkasgyepu
Hungary	Matrai Gyogyintezet	Gyongyos
Hungary	Local Institution - 007-057	Tatabanya
Hungary	Reformatus Pulmonologiai Centrum	Torokbalint
Ireland	Local Institution - 007-256	Cork
Ireland	Beaumont Hospital - Dublin	Dublin
Ireland	Local Institution - 007-251	Dublin
Ireland	Local Institution - 007-259	Dublin
Ireland	Local Institution - 007-257	Galway
Ireland	Local Institution - 007-258	Limerick
Ireland	Local Institution - 007-2565	Waterford
Israel	Emek Medical Center	Afula
Israel	Rambam Health Care Campus	Bat Galim
Israel	Soroka Medical Center	Beer Sheva
Israel	Local Institution - 007-263	Holon
Israel	Hadassah University Hospital Ein Kerem	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Kaplan Medical Center	Rehovot
Israel	Local Institution - 007-268	Tel Aviv
Israel	Ziv Medical Center	Zsfat
Italy	Local Institution - Unk016	Aviano
Italy	Istituto Tumori Bari Giovanni Paolo II - IRCCS	Bari
Italy	Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi	Bologna
Italy	Local Institution - 007-765	Brescia
Italy	Local Institution - 007-286	Candiolo
Italy	Local Institution - 007-762	Firenze
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino	Genova
Italy	"Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST"	Meldola
Italy	Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele	Milan
Italy	Istituto Europeo di Oncologia	Milan
Italy	Local Institution - 007-283	Milano
Italy	Local Institution - 007-318	Monza
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
Italy	Local Institution - Unk017	Padova
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Local Institution - 007-281	Perugia
Italy	Local Institution - 007-766	Pesaro
Italy	Local Institution - 007-767	Ravenna
Italy	Istituto Nazionale Tumori Regina Elena	Roma
Italy	Local Institution - Unk030	Rozzano
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	National Cancer Center - Korea	Goyang-si
Korea, Republic of	Inha University Hospital	Jung-Gu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Local Institution - 007-114	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Catholic University of Korea Saint Vincents Hospital	Suwon-Si
Malaysia	Local Institution - Unk048	George Town	Penang
Malaysia	Local Institution - Unk079	Johor Bahru	Johor
Malaysia	Local Institution - Unk075	Kuala Lumpur
Malaysia	Local Institution - Unk007	Petaling Jaya	Selangor
Mexico	Local Institution - Unk070	Guadalajara	Jalisco
Mexico	Local Institution - Unk034	Mexico	Distrito Federal
Mexico	Local Institution - Unk049	Mexico	Distrito Federal
Mexico	Local Institution - Unk026	Monterrey
Mexico	Local Institution - Unk037	Monterrey
Netherlands	Het Nederlands Kanker Instituut	Amsterdam
Netherlands	Local Institution - 007-308	Den Haag
Netherlands	Local Institution - 007-633	Dordrecht
Netherlands	Ziekenhuis St Jansdal Harderwijk	Harderwijk
Netherlands	Local Institution - 007-630	Nijmegen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Local Institution - 007-634	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	Local Institution - 007-305	Zwolle
Peru	Local Institution - Unk023	Arequipa
Peru	Local Institution - Unk044	Arequipa
Peru	Local Institution - Unk051	Arequipa
Peru	Local Institution - Unk031	Cercado De Lima	Lima
Peru	Local Institution - Unk040	Cusco
Peru	Local Institution - Unk022	Jesus Maria	Lima
Peru	Local Institution - Unk046	Lima
Peru	Local Institution - Unk024	Miraflores	Lima
Peru	Local Institution - Unk042	San Isidro	Lima
Peru	Local Institution - Unk071	San Isidro	Lima
Peru	Local Institution - Unk054	Surquillo	Lima
Peru	Local Institution - Unk080	Trujillo	La Libertad
Poland	Uniwersyteckie Centrum Kliniczne w Gdansku	Gdansk
Poland	Local Institution - 007-317	Kielce
Poland	Local Institution - 007-323	Krakow
Poland	MS Pnuemed - Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna	Lublin
Poland	Local Institution - 007-059	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy	Otwock
Poland	Local Institution - 007-389	Poznan
Poland	Pratia Poznan	Skorzewo
Poland	Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu	Torun
Poland	Local Institution - 007-056	Warszawa
Poland	Local Institution - 007-322	Warszawa
Portugal	Local Institution - 007-330	Coimbra
Portugal	Local Institution - 007-333	Guimaraes
Portugal	Hospital CUF Descobertas	Lisbon
Portugal	Local Institution - 007-642	Lisbon
Portugal	Local Institution - 007-334	Porto
Portugal	Local Institution - 007-339	Porto
Portugal	Unidade Local de Saude de Santo Antonio, E. P. E - Hospital Geral de Santo Antonio	Porto
Portugal	Local Institution - 007-335	Vila Nova de Gaia
Romania	Local Institution - 007-340	Cluj-Napoca
Romania	Local Institution - 007-515	Timi?oara
Singapore	Local Institution - 007-095	Singapore
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Local Institution - 007-610	Badalona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Dexeus	Barcelona
Spain	Hospital Universitari Vall dHebron	Barcelona
Spain	Local Institution - Unk081	Bilbao
Spain	Local Institution - Unk063	Burgos
Spain	Local Institution - Unk014	Jerez de la Frontera
Spain	Local Institution - 007-628	Las Palmas de Gran Canaria
Spain	Local Institution - Unk012	Leon
Spain	Institut Catala dOncologia - Hospital Duran i Reynals (ICO LHospitalet)	LHospitalet de Llobregat
Spain	Clinica Universidad de Navarra - Madrid	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Regional Universitario de Malaga - Hospital Civil	Malaga
Spain	Local Institution - 007-604	Santander
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Sweden	Local Institution - Unk013	Gavle
Taiwan	Local Institution - 007-124	Taichung
Taiwan	Local Institution - 007-127	Taichung
Taiwan	Local Institution - 007-128	Taichung City
Taiwan	Local Institution - 007-122	Tainan
Taiwan	Chi Mei Hospital - Liouying	Tainan City
Taiwan	Local Institution - 007-120	Taipei City
Taiwan	Local Institution - 007-126	Taipei City
Taiwan	Local Institution - 007-125	Taoyuan
Turkey	Local Institution - 007-061	Alanya
Turkey	Local Institution - 007-096	Altindag
Turkey	Local Institution - 007-066	Ankara
Turkey	Local Institution - 007-3810	Antalya
Turkey	Local Institution - 007-098	Bahcelievler
Turkey	Local Institution - 007-060	Bornova
Turkey	Local Institution - 007-055	Cankaya
Turkey	Local Institution - 007-054	Edirne
Turkey	Local Institution - 007-069	Istanbul
Turkey	Local Institution - 007-099	Izmir
Turkey	Local Institution - 007-3811	Kocaeli
Turkey	Local Institution - 007-097	Malatya
Turkey	Local Institution - 007-068	Mamak
Turkey	Local Institution - 007-062	Sisli
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Local Institution - 007-415	Edinburgh
United Kingdom	Local Institution - 007-403	Kent
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Guys and Saint Thomas NHS Foundation Trust	London
United Kingdom	Local Institution - 007-402	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Surrey
United States	New York Oncology Hematology - Albany Medical Center	Albany	New York
United States	Local Institution - Unk041	Allentown	Pennsylvania
United States	Providence - Saint Joseph Home Health - Anaheim	Anaheim	California
United States	University Cancer & Blood Center (UCBC) - Athens	Athens	Georgia
United States	Local Institution - Unk052	Atlanta	Georgia
United States	USOR - Texas Oncology - South Austin	Austin	Texas
United States	GenesisCare USA	Aventura	Florida
United States	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Local Institution - Unk011	Baton Rouge	Louisiana
United States	Bay Pines Veterans Affairs Healthcare System	Bay Pines	Florida
United States	Local Institution - 007-993	Belleville	New Jersey
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	USOR - Minnesota Oncology - Burnsville	Burnsville	Minnesota
United States	TOI Clinical Research (ICIR)	Cerritos	California
United States	Local Institution - Unk038	Charleston	South Carolina
United States	Local Institution - 007-955	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	USOR - Oncology Hematology Care - Blue Ash	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Mark H. Zangmeister Cancer Center	Columbus	Ohio
United States	Local Institution - 007-592	Dallas	Texas
United States	Local Institution - Unk059	Dallas	Texas
United States	Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	USOR - Texas Oncology Northeast Texas - Denison	Denison	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Astera Cancer Care - East Brunswick	East Brunswick	New Jersey
United States	USOR - Willamette Valley Cancer Institute and Research Center - Eugene	Eugene	Oregon
United States	USOR - Virginia Cancer Specialists - Fairfax Office	Fairfax	Virginia
United States	SCRI - Florida Cancer Specialists - South Region Research Office	Fort Myers	Florida
United States	USOR - Texas Oncology - Fredericksburg	Fredericksburg	Texas
United States	West Cancer Center & Research Institute - East Campus	Germantown	Tennessee
United States	Goshen Center for Cancer Care	Goshen	Indiana
United States	John Theurer Cancer Center	Hackensack	New Jersey
United States	Local Institution - 007-897	Honolulu	Hawaii
United States	Local Institution - Unk005	Honolulu	Hawaii
United States	Local Institution - 007-848	Houston	Texas
United States	Local Institution - Unk064	Huntington	West Virginia
United States	Local Institution - 007-999	Irving	Texas
United States	Jackson Oncology Associates - The Hederman Cancer Center	Jackson	Mississippi
United States	21st Century Oncology of Jacksonville - North Lee Street	Jacksonville	Florida
United States	Cancer Specialists of North Florida - Southpoint	Jacksonville	Florida
United States	Local Institution - 007-829	Jacksonville	Florida
United States	Kettering Health Cancer Center - Main Campus	Kettering	Ohio
United States	OptumCare Nevada	Las Vegas	Nevada
United States	Lexington Medical Cancer Center Hematology/Oncology	Lexington	Kentucky
United States	USOR - Rocky Mountain Cancer Centers - Lone Tree	Lone Tree	Colorado
United States	MemorialCare - Long Beach Medical Center	Long Beach	California
United States	TRIO - Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	Local Institution - 007-579	Los Angeles	California
United States	Local Institution - 007-388	Louisville	Kentucky
United States	Local Institution - Unk057	Madison	Wisconsin
United States	Local Institution - Unk068	Madison	Wisconsin
United States	Local Institution - 007-786	Marietta	Georgia
United States	Local Institution - 007-064	Maywood	Illinois
United States	Miami Veterans Affairs Healthcare System	Miami	Florida
United States	Local Institution - 007-822	Minneapolis	Minnesota
United States	Local Institution - Unk006	Minneapolis	Minnesota
United States	Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology	Nashville	Tennessee
United States	USOR - Illinois Cancer Specialists - Niles	Niles	Illinois
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	USOR - Texas Oncology - Odessa West Texas Cancer Center	Odessa	Texas
United States	Nebraska Cancer Specialists - Midwest Cancer Center - Legacy	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Advocate Medical Group Oncology	Park Ridge	Illinois
United States	USOR - Woodlands Medical Specialists	Pensacola	Florida
United States	Local Institution - Unk061	Peoria	Illinois
United States	Local Institution - 007-5477	Pittsburgh	Pennsylvania
United States	USOR - Arizona Oncology - Prescott Valley	Prescott Valley	Arizona
United States	Local Institution - 007-960	Providence	Rhode Island
United States	Local Institution - Unk045	Rancho Mirage	California
United States	Local Institution - Unk077	Rhinebeck	New York
United States	Virginia Cancer Institute - West End	Richmond	Virginia
United States	Local Institution - 007-830	Rochester	Minnesota
United States	Oregon Oncology Specialists	Salem	Oregon
United States	Local Institution - 007-912	Salt Lake City	Utah
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Providence Medical Group - Santa Rosa	Santa Rosa	California
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Local Institution - 007-5475	Spartanburg	South Carolina
United States	Highlands Oncology Group - Springdale	Springdale	Arkansas
United States	Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)	Stockton	California
United States	SCRI - Florida Cancer Specialists - Tallahassee Cancer Center	Tallahassee	Florida
United States	James A. Haley Veterans Hospital	Tampa	Florida
United States	Local Institution - Unk065	Tampa	Florida
United States	Local Institution - 007-784	Teaneck	New Jersey
United States	USOR - Texas Oncology - The Woodlands	The Woodlands	Texas
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center	Vancouver	Washington
United States	Local Institution - 007-5476	Washington	District of Columbia
United States	SCRI - Florida Cancer Specialists - West Palm Beach	West Palm Beach	Florida
United States	Local Institution - Unk072	Weston	Florida
United States	Local Institution - Unk032	Westwood	Kansas
United States	Cancer Center of Kansas - Wichita - Heritage Plaza	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Singapore,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	22 months
Primary	Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab	Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival	36 months
Secondary	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.	22 months
Secondary	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.	22 months
Secondary	Phase 2: Progression Free Survival	Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.	22 months
Secondary	Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations	1-Year Survival rate	12 months
Secondary	Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations	Overall Survival (OS)	22 months
Secondary	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	22 months
Secondary	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.	36 months
Secondary	Phase 3: To evaluate the PK of adagrasib administered in the study population	Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations	36 months
Secondary	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	36 months
Secondary	Phase 3: Progression Free Survival per RECIST 1.1 by Investigator	Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.	36 months
Secondary	Phase 3: Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR	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.	36 months
Secondary	Phase 3: Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR	Defined as the percent of patients documented to have a confirmed CR or PR.	36 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting