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

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 nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.

Study Overview

• Status: Recruiting
• Conditions: Advanced Non-Small Cell Lung Cancer; Metastatic Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Adagrasib; Drug: Adagrasib; Drug: Adagrasib; Drug: Adagrasib; Drug: Pembrolizumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 806
• Phase: Phase 2; Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Mirati Therapeutics Study Locator Services; Phone Number: 18448935530; Email: miratistudylocator@careboxhealth.com

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Research Site
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Research Site
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Recruiting
      • Research Site
• Austria
  • Linz, Austria, A-4020
    • Recruiting
    • Research Site
  • Vienna, Austria, 1210
    • Recruiting
    • Research Site
  • Carinthia
    • Klagenfurt, Carinthia, Austria, 9020
      • Recruiting
      • Research Site
• Belgium
  • Hasselt, Belgium, 3500
    • Recruiting
    • Research Site
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Research Site
  • Vlaams Brabant
    • Gent, Vlaams Brabant, Belgium, 9000
      • Recruiting
      • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Recruiting
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Completed
      • Research Site
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Research Site
      • Contact: Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Completed
      • Research Site
• Czechia
  • Olomouc, Czechia, 779 00
    • Recruiting
    • Research Site
  • Ostrava, Czechia, 703 00
    • Recruiting
    • Research Site
  • Praha, Czechia, 180 81
    • Recruiting
    • Research Site
  • Central Bohemian
    • Hořovice, Central Bohemian, Czechia, 268 31
      • Recruiting
      • Research Site
• Germany
  • Frankfurt, Germany, 60488
    • Recruiting
    • Research Site
  • Gießen, Germany, 35392
    • Recruiting
    • Research Site
  • Hemer, Germany, 58675
    • Recruiting
    • Research Site
  • Oldenburg, Germany, 26121
    • Recruiting
    • Research Site
  • Baden-Wuerttemberg
    • Esslingen, Baden-Wuerttemberg, Germany, 73730
      • Recruiting
      • Research Site
  • Bavaria
    • Kempten, Bavaria, Germany, 87439
      • Recruiting
      • Research Site
  • Bayern
    • Munchen, Bayern, Germany, 81925
      • Recruiting
      • Research Site
  • Hessen
    • Kassel, Hessen, Germany, 34125
      • Recruiting
      • Research Site
  • Schleswig-Holstein
    • Großhansdorf, Schleswig-Holstein, Germany, 22927
      • Recruiting
      • Research Site
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Research Site
• Hungary
  • Budapest, Hungary, 1121
    • Recruiting
    • Research Site
  • Budapest, Hungary, 1083
    • Recruiting
    • Research Site
  • Budapest, Hungary, 1122
    • Recruiting
    • Research Site
  • Gyöngyös, Hungary, 3200
    • Recruiting
    • Research Site
  • Torokbalint, Hungary, 2045
    • Recruiting
    • Research Site
• Ireland
  • Dublin, Ireland, 9
    • Recruiting
    • Research Site
• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • Research Site
  • Be'er Sheva, Israel, 8410101
    • Recruiting
    • Research Site
  • Haifa, Israel, 3109601
    • Completed
    • Research Site
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Research Site
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Research Site
  • Reẖovot, Israel, 7661041
    • Recruiting
    • Research Site
  • Safed, Israel, 1311001
    • Recruiting
    • Research Site
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Research Site
  • Bologna, Italy, 40138
    • Recruiting
    • Research Site
  • Genova, Italy, 16132
    • Recruiting
    • Research Site
  • Milan, Italy, 20132
    • Recruiting
    • Research Site
  • Milan, Italy, 20141
    • Recruiting
    • Research Site
  • Napoli, Italy, 80131
    • Completed
    • Research Site
  • Parma, Italy, 43126
    • Recruiting
    • Research Site
  • Roma, Italy, 00168
    • Recruiting
    • Research Site
  • Rome, Italy, 00144
    • Recruiting
    • Research Site
  • Varese, Italy, 21100
    • Recruiting
    • Research Site
  • Forli-Cesena
    • Meldola, Forli-Cesena, Italy, 47014
      • Recruiting
      • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Recruiting
    • Research Site
  • Cheongju-si, Korea, Republic of, 28644
    • Recruiting
    • Research Site
  • Daegu, Korea, Republic of, 41404
    • Completed
    • Research Site
  • Goyang-si, Korea, Republic of, 410-769
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Research Site
  • Gyeonggi-do
    • Incheon, Gyeonggi-do, Korea, Republic of, 22332
      • Recruiting
      • Research Site
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • Recruiting
      • Research Site
• Netherlands
  • Harderwijk, Netherlands, 3844 DG
    • Recruiting
    • Research Site
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • Research Site
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Recruiting
      • Research Site
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Recruiting
      • Research Site
• Poland
  • Lublin, Poland, 20-064
    • Recruiting
    • Research Site
  • Otwock, Poland, 05-400
    • Recruiting
    • Research Site
  • Skorzewo, Poland, 60-185
    • Completed
    • Research Site
  • Toruń, Poland, 87-100
    • Recruiting
    • Research Site
  • Gdansk
    • Gdańsk, Gdansk, Poland, 80-952
      • Completed
      • Research Site
• Portugal
  • Lisbon, Portugal, 1998-018
    • Recruiting
    • Research Site
  • Porto, Portugal, 4099-001
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08036
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08025
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08028
    • Recruiting
    • Research Site
  • Madrid, Spain, 28027
    • Recruiting
    • Research Site
  • Madrid, Spain, 28040
    • Recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Completed
    • Research Site
  • Málaga, Spain, 29011
    • Recruiting
    • Research Site
  • Santiago De Compostela, Spain, 15706
    • Recruiting
    • Research Site
  • Sevilla, Spain, 41013
    • Recruiting
    • Research Site
  • Valencia, Spain, 46010
    • Recruiting
    • Research Site
  • Valencia, Spain, 46026
    • Recruiting
    • Research Site
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08908
      • Recruiting
      • Research Site
  • La Coruña
    • A Coruña, La Coruña, Spain, 15006
      • Recruiting
      • Research Site
• Taiwan
  • Tainan City, Taiwan, 73657
    • Recruiting
    • Research Site
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • Research Site
  • England
    • Birmingham, England, United Kingdom, B9 5SS
      • Recruiting
      • Research Site
    • Guildford, England, United Kingdom, GU2 7XX
      • Recruiting
      • Research Site
    • London, England, United Kingdom, SE1 9RT
      • Recruiting
      • Research Site
    • Manchester, England, United Kingdom, M20 4BX
      • Recruiting
      • Research Site
• United States
  • Arizona
    • Prescott Valley, Arizona, United States, 86314
      • Completed
      • Research Site
    • Tucson, Arizona, United States, 85715
      • Recruiting
      • Research Site
  • Arkansas
    • Springdale, Arkansas, United States, 72762
      • Completed
      • Research Site
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Research Site
    • Long Beach, California, United States, 90806
      • Recruiting
      • Research Site
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Research Site
    • San Francisco, California, United States, 94121
      • Recruiting
      • Research Site
    • San Francisco, California, United States, 94143
      • Completed
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Research Site
    • Stockton, California, United States, 95219
      • Recruiting
      • Research Site
    • Whittier, California, United States, 90602
      • Completed
      • Research Site
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Research Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Recruiting
      • Research Site
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Recruiting
      • Research Site
    • Fort Myers, Florida, United States, 33901
      • Recruiting
      • Research Site
    • Fort Myers, Florida, United States, 33907
      • Recruiting
      • Research Site
    • Jacksonville, Florida, United States, 32204
      • Recruiting
      • Research Site
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Research Site
    • Miami, Florida, United States, 33125
      • Recruiting
      • Research Site
    • Orlando, Florida, United States, 32804
      • Recruiting
      • Research Site
    • Pensacola, Florida, United States, 32503
      • Recruiting
      • Research Site
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • Research Site
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Research Site
    • West Palm Beach, Florida, United States, 33401
      • Recruiting
      • Research Site
  • Georgia
    • Athens, Georgia, United States, 30607
      • Recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Research Site
    • Niles, Illinois, United States, 60714
      • Recruiting
      • Research Site
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Research Site
  • Indiana
    • Goshen, Indiana, United States, 46580
      • Recruiting
      • Research Site
  • Kansas
    • Wichita, Kansas, United States, 67460
      • Recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Recruiting
      • Research Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Completed
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Completed
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Research Site
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Recruiting
      • Research Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Recruiting
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Recruiting
      • Research Site
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Research Site
    • Hackensack, New Jersey, United States, 07601
      • Completed
      • Research Site
  • New York
    • Albany, New York, United States, 12206
      • Recruiting
      • Research Site
    • Bronx, New York, United States, 10467
      • Recruiting
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Research Site
    • Columbus, Ohio, United States, 43219
      • Recruiting
      • Research Site
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Research Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Research Site
    • Salem, Oregon, United States, 97301
      • Recruiting
      • Research Site
    • Tigard, Oregon, United States, 97223
      • Recruiting
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Research Site
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • Research Site
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Research Site
  • Texas
    • Amarillo, Texas, United States, 79124
      • Recruiting
      • Research Site
    • Arlington, Texas, United States, 76012
      • Completed
      • Research Site
    • Austin, Texas, United States, 78745
      • Recruiting
      • Research Site
    • Bedford, Texas, United States, 76022
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Research Site
    • Denison, Texas, United States, 75020
      • Recruiting
      • Research Site
    • Fredericksburg, Texas, United States, 78624
      • Completed
      • Research Site
    • The Woodlands, Texas, United States, 77380
      • Completed
      • Research Site
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Research Site
    • Richmond, Virginia, United States, 23230
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1%; Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab	Drug: Adagrasib; Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a); Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 600 mg BID monotherapy (Cohort 1b); Drug: Adagrasib; adagrasib 400 mg BID in combination with pembrolizumab; Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W; Other Names: Pemrolizumab
Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1%; Cohort 1b: Adagrasib BID monotherapy	Drug: Adagrasib; Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a); Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 600 mg BID monotherapy (Cohort 1b); Drug: Adagrasib; adagrasib 400 mg BID in combination with pembrolizumab; Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W; Other Names: Pemrolizumab
Experimental: Phase 2 Cohort 2: PD-L1 TPS ≥1%; Cohort 2: Adagrasib BID in combination with pembrolizumab	Drug: Adagrasib; Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a); Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 600 mg BID monotherapy (Cohort 1b); Drug: Adagrasib; adagrasib 400 mg BID in combination with pembrolizumab; Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W; Other Names: Pemrolizumab
Experimental: Phase 3 Cohort 3 Investigational Arm; Adagrasib BID in combination with pembrolizumab	Drug: Adagrasib; Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a); Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 600 mg BID monotherapy (Cohort 1b); Drug: Adagrasib; adagrasib 400 mg BID in combination with pembrolizumab; Other Names: Pembrolizumab; Drug: Adagrasib; Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W; Other Names: Pemrolizumab
Active Comparator: Phase 3 Cohort 4 Comparator Arm; Pembrolizumab	Drug: Pembrolizumab; Pembrolizumab 200 mg IV Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations	1-Year Survival rate	12 months
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations	Overall Survival (OS)	22 months
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
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
Phase 3: To evaluate the PK of adagrasib administered in the study population	Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations	36 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Barbara Wamil, MD, Mirati Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Non-small cell lung cancer; KRAS G12C; Metastatic Non-Small Cell Lung Cancer; Adagrasib; TPS; Krazati
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Pembrolizumab; Adagrasib
• Other Study ID Numbers: 849-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No