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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 2 / Fase 3626 partecipanti ricercati770 centri47 paesi

Categorie

Oncologia71%Apparato respiratorio29%

Registrato in 1 registro

ClinicalTrials.govNCT04613596Apri questa scheda su ClinicalTrials.govSincronizzato 5 giorni fa

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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.

Sintesi

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.

Patologie

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

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 2 / Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	NONE (0)
Arruolamento	626 partecipanti ricercati

Sponsor e collaboratori

Mirati Therapeutics Inc. Sponsor

Bracci e interventi

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

Interventi

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

Esiti misurati

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

Date

Date
Data di inizio	2 dicembre 2020 (effettiva)
Conclusione primaria	31 ottobre 2028 (stimata)
Conclusione	31 ottobre 2029 (stimata)
Prima pubblicazione	3 novembre 2020 (effettiva)
Ultimo aggiornamento	16 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

378 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato o regione	Stato
Aresma - Clinica Adventista Belgrano	Belgrano	Buenos Aires	In reclutamento
Local Institution - 007-5002	Buenos Aires		Non ancora in reclutamento
Instituto Medico Especializado Alexander Fleming	Buenos Aires		In reclutamento
Instituto Argentino de Diagnostico y Tratamiento	Ciudad Autonoma de Buenos Aires	Buenos Aires	In reclutamento
Fundacion Respirar	Ciudad Autonoma de Buenos Aires	Buenos Aires	In reclutamento
Local Institution - Unk043	Ciudad Autonoma de Buenos Aires	Buenos Aires	Attivo, non in reclutamento
Instituto Oncologico de Cordoba (IONC)	Córdoba		In reclutamento
Local Institution - 007-436	Pergamino	Buenos Aires	Non ancora in reclutamento
Local Institution - Unk033	Porto Alegre		Attivo, non in reclutamento
Sanatorio Parque	Rosario	Santa Fe Province	In reclutamento
Instituto de Oncologia de Rosario	Rosario	Santa Fe Province	In reclutamento
Local Institution - Unk020	Río Cuarto		Attivo, non in reclutamento
Centro Oncologico Korben	San Pedro	Buenos Aires	In reclutamento
Local Institution - 007-433	Viedma		Non ancora in reclutamento

Australia

Australia
Struttura	Città	Stato
Ballarat Regional Integrated Cancer Center	Ballarat	In reclutamento
Flinders Medical Centre	Bedford Park	In reclutamento
Local Institution - 007-004	Clayton	Ritirato
Canberra Hospital	Garran	In reclutamento
Icon Cancer Centre	Hyde Park	In reclutamento
Port Macquarie Base Hospital	Port Macquarie	In reclutamento
Cancer Care Wollongong	Wollongong	In reclutamento
Princess Alexandra Hospital	Woolloongabba	In reclutamento

Austria

Austria
Struttura	Città	Stato
Klinikum Klagenfurt Am Worthersee	Klagenfurt	In reclutamento
Universitatsklinikum Krems	Krems	In reclutamento
Ordensklinikum Linz Elisabethinen	Linz	In reclutamento
Wiener Gesundheitsverbund - Klinik Hietzing	Vienna	In reclutamento
Wiener Gesundheitsverbund - Klinik Floridsdorf	Vienna	In reclutamento
Medizinische Universitat Wien	Vienna	In reclutamento

Belgium

Belgium
Struttura	Città	Stato
Universitair Ziekenhuis Antwerpen	Edegem	In reclutamento
Algemeen Ziekenhuis Maria Middelares	Ghent	In reclutamento
Jessa Ziekenhuis - Campus Virga Jesse	Hasselt	In reclutamento
Local Institution - 007-152	Roeselare	Ritirato

Brazil

Brazil
Struttura	Città	Stato o regione	Stato
Local Institution - Unk060	Barretos		Attivo, non in reclutamento
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor	Barretos		In reclutamento
CEPON - Centro de Pesquisas Oncologicas	Florianópolis	Santa Catarina	In reclutamento
Local Institution - Unk002	Ijuí		Attivo, non in reclutamento
Local Institution - Unk050	Lajeado	Rio Grande do Sul	Attivo, non in reclutamento
Liga Contra o Cancer - Centro Avancado de Oncologia	Natal	Rio Grande do Norte	In reclutamento
Local Institution - 007-5052	Porto Alegre	Rio Grande do Sul	Non ancora in reclutamento
Local Institution - Unk015	Porto Alegre	Rio Grande do Sul	Attivo, non in reclutamento
Hospital Nossa Senhora da Conceicao	Porto Alegre		In reclutamento
Local Institution - Unk003	Rio de Janeiro		Attivo, non in reclutamento
Hospital Santa Izabel	Salvador	Estado de Bahia	In reclutamento
Local Institution - Unk019	São José do Rio Preto		Attivo, non in reclutamento
Local Institution - Unk074	São Paulo		Attivo, non in reclutamento

Bulgaria

Bulgaria
Struttura	Città	Stato
Multiprofile Hospital For Active Treatment - Dr. Tota Venkova	Gabrovo	In reclutamento
Specialized Hospital for Active Oncology Treatment - Haskovo SLLC (SBALO - Haskovo - EOOD)	Haskovo	In reclutamento
Complex Oncology Center - Plovdiv - Base II	Plovdiv	In reclutamento
University Multiprofile Hospital for Active Treatment St. Ivan Rilski	Sofia	In reclutamento
Complex Oncology Center - Vratsa	Vratsa	In reclutamento

Nella scheda del registro sono indicati altri 720 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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