NCT04613596ClinicalTrials.gov

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

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En resumen

Fase 2 / Fase 3626 participantes buscados770 centros47 países

Categorías

Oncología71%Respiratorio29%

Registrado en 1 registro

ClinicalTrials.govNCT04613596Abrir este registro en ClinicalTrials.govSincronizado hace 6 días

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2020-11-03; recorded start 2020-12-02
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 19 other studies in this databaseCounted from the lead sponsor named in the record (Mirati Therapeutics Inc.)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 770 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 626 participants (target), run at 770 sites, across 47 countries.

How this score is built

Enrolment27/40
626 participants (target)
Site count25/25
770 sites
Country count15/15
47 countries
Planned duration10/10
Planned over about 109 months
Sponsor scale4/10
Mirati Therapeutics Inc. has led 19 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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: 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 \> 2.0 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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2 / Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	NONE (0)
Inscripción	626 participantes buscados

Patrocinador y colaboradores

Mirati Therapeutics Inc. Patrocinador

Grupos e intervenciones

Phase 2 Cohort 1a: PD-L1 TPS <1%EXPERIMENTAL
Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
Phase 2 Cohort 1b: PD-L1 TPS <1%EXPERIMENTAL
Cohort 1b: Adagrasib BID monotherapy
Phase 2 Cohort 2: PD-L1 TPS ≥1%EXPERIMENTAL
Cohort 2: Adagrasib BID in combination with pembrolizumab
Phase 3 Cohort 3 Investigational ArmEXPERIMENTAL
Adagrasib BID in combination with pembrolizumab
Phase 3 Cohort 4 Comparator ArmACTIVE_COMPARATOR
Pembrolizumab

Intervenciones

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

Variables de resultado

Variable de resultado principal
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)
Plazo 22 months
Variable de resultado principal
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
Plazo 36 months
Variable de resultado secundaria
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.
Plazo 22 months
Variable de resultado secundaria
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.
Plazo 22 months
Variable de resultado secundaria
Phase 2: Progression Free Survival
Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.
Plazo 22 months
Variable de resultado secundaria
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
1-Year Survival rate
Plazo 12 months
Variable de resultado secundaria
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Overall Survival (OS)
Plazo 22 months
Variable de resultado secundaria
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
Plazo 22 months
Variable de resultado secundaria
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.
Plazo 36 months
Variable de resultado secundaria
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
Plazo 36 months
Variable de resultado secundaria
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.
Plazo 36 months
Variable de resultado secundaria
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.
Plazo 36 months
Variable de resultado secundaria
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.
Plazo 36 months

Fechas

Fechas
Fecha de inicio	2 de diciembre de 2020 (real)
Finalización principal	31 de octubre de 2028 (estimada)
Finalización	31 de octubre de 2029 (estimada)
Primera publicación	3 de noviembre de 2020 (real)
Última actualización	16 de septiembre de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	septiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

378 centros están en reclutamiento

Argentina

Argentina
Centro	Ciudad	Estado o región	Estado
Aresma - Clinica Adventista Belgrano	Belgrano	Buenos Aires	En reclutamiento
Local Institution - 007-5002	Buenos Aires		Aún no recluta
Instituto Medico Especializado Alexander Fleming	Buenos Aires		En reclutamiento
Instituto Argentino de Diagnostico y Tratamiento	Ciudad Autonoma de Buenos Aires	Buenos Aires	En reclutamiento
Fundacion Respirar	Ciudad Autonoma de Buenos Aires	Buenos Aires	En reclutamiento
Local Institution - Unk043	Ciudad Autonoma de Buenos Aires	Buenos Aires	Activo, sin reclutar
Instituto Oncologico de Cordoba (IONC)	Córdoba		En reclutamiento
Local Institution - 007-436	Pergamino	Buenos Aires	Aún no recluta
Local Institution - Unk033	Porto Alegre		Activo, sin reclutar
Sanatorio Parque	Rosario	Santa Fe Province	En reclutamiento
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province	En reclutamiento
Local Institution - Unk020	Río Cuarto		Activo, sin reclutar
Centro Oncologico Korben	San Pedro	Buenos Aires	En reclutamiento
Local Institution - 007-433	Viedma		Aún no recluta

Australia

Australia
Centro	Ciudad	Estado
Ballarat Regional Integrated Cancer Center	Ballarat	En reclutamiento
Flinders Medical Centre	Bedford Park	En reclutamiento
Local Institution - 007-004	Clayton	Retirado
Canberra Hospital	Garran	En reclutamiento
Icon Cancer Centre	Hyde Park	En reclutamiento
Port Macquarie Base Hospital	Port Macquarie	En reclutamiento
Cancer Care Wollongong	Wollongong	En reclutamiento
Princess Alexandra Hospital	Woolloongabba	En reclutamiento

Austria

Austria
Centro	Ciudad	Estado
Klinikum Klagenfurt Am Worthersee	Klagenfurt	En reclutamiento
Universitatsklinikum Krems	Krems	En reclutamiento
Ordensklinikum Linz Elisabethinen	Linz	En reclutamiento
Wiener Gesundheitsverbund - Klinik Hietzing	Vienna	En reclutamiento
Wiener Gesundheitsverbund - Klinik Floridsdorf	Vienna	En reclutamiento
Medizinische Universitat Wien	Vienna	En reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado
Universitair Ziekenhuis Antwerpen	Edegem	En reclutamiento
Algemeen Ziekenhuis Maria Middelares	Ghent	En reclutamiento
Jessa Ziekenhuis - Campus Virga Jesse	Hasselt	En reclutamiento
Local Institution - 007-152	Roeselare	Retirado

Brazil

Brazil
Centro	Ciudad	Estado o región	Estado
Local Institution - Unk060	Barretos		Activo, sin reclutar
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor	Barretos		En reclutamiento
CEPON - Centro de Pesquisas Oncologicas	Florianópolis	Santa Catarina	En reclutamiento
Local Institution - Unk002	Ijuí		Activo, sin reclutar
Local Institution - Unk050	Lajeado	Rio Grande do Sul	Activo, sin reclutar
Liga Contra o Cancer - Centro Avancado de Oncologia	Natal	Rio Grande do Norte	En reclutamiento
Local Institution - 007-5052	Porto Alegre	Rio Grande do Sul	Aún no recluta
Local Institution - Unk015	Porto Alegre	Rio Grande do Sul	Activo, sin reclutar
Hospital Nossa Senhora da Conceicao	Porto Alegre		En reclutamiento
Local Institution - Unk003	Rio de Janeiro		Activo, sin reclutar
Hospital Santa Izabel	Salvador	Estado de Bahia	En reclutamiento
Local Institution - Unk019	São José do Rio Preto		Activo, sin reclutar
Local Institution - Unk074	São Paulo		Activo, sin reclutar

Bulgaria

Bulgaria
Centro	Ciudad	Estado
Multiprofile Hospital For Active Treatment - Dr. Tota Venkova	Gabrovo	En reclutamiento
Specialized Hospital for Active Oncology Treatment - Haskovo SLLC (SBALO - Haskovo - EOOD)	Haskovo	En reclutamiento
Complex Oncology Center - Plovdiv - Base II	Plovdiv	En reclutamiento
University Multiprofile Hospital for Active Treatment St. Ivan Rilski	Sofia	En reclutamiento
Complex Oncology Center - Vratsa	Vratsa	En reclutamiento

En el registro figuran 720 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04613596