xMedica

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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 2 / المرحلة 3مطلوب 626 مشاركاً770 موقعاً47 دولة

الفئات

علم الأورام71%الجهاز التنفسي29%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

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

ملخص

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.

الحالات

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

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2 / المرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 626 مشاركاً

الجهة الراعية والمتعاونون

  • Mirati Therapeutics Inc. الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء Adagrasib

    Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

  • دواء Adagrasib

    Adagrasib 600 mg BID monotherapy (Cohort 1b)

  • دواء Adagrasib

    adagrasib 400 mg BID in combination with pembrolizumab

  • دواء Adagrasib

    Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

  • دواء Pembrolizumab

    Pembrolizumab 200 mg IV Q3W

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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)

    الإطار الزمني 22 months

  2. مقياس النتيجة الأولي

    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

    الإطار الزمني 36 months

  3. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 22 months

  4. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 22 months

  5. مقياس النتيجة الثانوي

    Phase 2: Progression Free Survival

    Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

    الإطار الزمني 22 months

  6. مقياس النتيجة الثانوي

    Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations

    1-Year Survival rate

    الإطار الزمني 12 months

  7. مقياس النتيجة الثانوي

    Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations

    Overall Survival (OS)

    الإطار الزمني 22 months

  8. مقياس النتيجة الثانوي

    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

    الإطار الزمني 22 months

  9. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 36 months

  10. مقياس النتيجة الثانوي

    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

    الإطار الزمني 36 months

  11. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 36 months

  12. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 36 months

  13. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 36 months

التواريخ

تاريخ البدء2 ديسمبر 2020 (فعلي)
الإتمام الأولي31 أكتوبر 2028 (تقديري)
الإتمام31 أكتوبر 2029 (تقديري)
أول نشر3 نوفمبر 2020 (فعلي)
آخر تحديث16 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

378 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Aresma - Clinica Adventista BelgranoBelgranoBuenos Airesقيد التجنيد
Local Institution - 007-5002Buenos Airesلم يبدأ التجنيد بعد
Instituto Medico Especializado Alexander FlemingBuenos Airesقيد التجنيد
Instituto Argentino de Diagnostico y TratamientoCiudad Autonoma de Buenos AiresBuenos Airesقيد التجنيد
Fundacion RespirarCiudad Autonoma de Buenos AiresBuenos Airesقيد التجنيد
Local Institution - Unk043Ciudad Autonoma de Buenos AiresBuenos Airesنشط، دون تجنيد
Instituto Oncologico de Cordoba (IONC)Córdobaقيد التجنيد
Local Institution - 007-436PergaminoBuenos Airesلم يبدأ التجنيد بعد
Local Institution - Unk033Porto Alegreنشط، دون تجنيد
Sanatorio ParqueRosarioSanta Fe Provinceقيد التجنيد
Instituto de Oncologia de RosarioRosarioSanta Fe Provinceقيد التجنيد
Local Institution - Unk020Río Cuartoنشط، دون تجنيد
Centro Oncologico KorbenSan PedroBuenos Airesقيد التجنيد
Local Institution - 007-433Viedmaلم يبدأ التجنيد بعد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Ballarat Regional Integrated Cancer CenterBallaratقيد التجنيد
Flinders Medical CentreBedford Parkقيد التجنيد
Local Institution - 007-004Claytonمسحوب
Canberra HospitalGarranقيد التجنيد
Icon Cancer CentreHyde Parkقيد التجنيد
Port Macquarie Base HospitalPort Macquarieقيد التجنيد
Cancer Care WollongongWollongongقيد التجنيد
Princess Alexandra HospitalWoolloongabbaقيد التجنيد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Klinikum Klagenfurt Am WortherseeKlagenfurtقيد التجنيد
Universitatsklinikum KremsKremsقيد التجنيد
Ordensklinikum Linz ElisabethinenLinzقيد التجنيد
Wiener Gesundheitsverbund - Klinik HietzingViennaقيد التجنيد
Wiener Gesundheitsverbund - Klinik FloridsdorfViennaقيد التجنيد
Medizinische Universitat WienViennaقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Universitair Ziekenhuis AntwerpenEdegemقيد التجنيد
Algemeen Ziekenhuis Maria MiddelaresGhentقيد التجنيد
Jessa Ziekenhuis - Campus Virga JesseHasseltقيد التجنيد
Local Institution - 007-152Roeselareمسحوب

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Local Institution - Unk060Barretosنشط، دون تجنيد
Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de AmorBarretosقيد التجنيد
CEPON - Centro de Pesquisas OncologicasFlorianópolisSanta Catarinaقيد التجنيد
Local Institution - Unk002Ijuíنشط، دون تجنيد
Local Institution - Unk050LajeadoRio Grande do Sulنشط، دون تجنيد
Liga Contra o Cancer - Centro Avancado de OncologiaNatalRio Grande do Norteقيد التجنيد
Local Institution - 007-5052Porto AlegreRio Grande do Sulلم يبدأ التجنيد بعد
Local Institution - Unk015Porto AlegreRio Grande do Sulنشط، دون تجنيد
Hospital Nossa Senhora da ConceicaoPorto Alegreقيد التجنيد
Local Institution - Unk003Rio de Janeiroنشط، دون تجنيد
Hospital Santa IzabelSalvadorEstado de Bahiaقيد التجنيد
Local Institution - Unk019São José do Rio Pretoنشط، دون تجنيد
Local Institution - Unk074São Pauloنشط، دون تجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
Multiprofile Hospital For Active Treatment - Dr. Tota VenkovaGabrovoقيد التجنيد
Specialized Hospital for Active Oncology Treatment - Haskovo SLLC (SBALO - Haskovo - EOOD)Haskovoقيد التجنيد
Complex Oncology Center - Plovdiv - Base IIPlovdivقيد التجنيد
University Multiprofile Hospital for Active Treatment St. Ivan RilskiSofiaقيد التجنيد
Complex Oncology Center - VratsaVratsaقيد التجنيد

يُدرَج 720 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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