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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04613596




Registration number
NCT04613596
Ethics application status
Date submitted
28/10/2020
Date registered
3/11/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
CA239-0009
Secondary ID [2] 0 0
CA239-0009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Non-Small Cell Lung Cancer 0 0
Metastatic Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Adagrasib
Treatment: Drugs - Pembrolizumab

Experimental: Phase 2 Cohort 1a: PD-L1 TPS <1% - Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab

Experimental: Phase 2 Cohort 1b: PD-L1 TPS <1% - Cohort 1b: Adagrasib BID monotherapy

Experimental: Phase 2 Cohort 2: PD-L1 TPS =1% - Cohort 2: Adagrasib BID in combination with pembrolizumab

Experimental: Phase 3 Cohort 3 Investigational Arm - Adagrasib BID in combination with pembrolizumab

Active comparator: Phase 3 Cohort 4 Comparator Arm - Pembrolizumab


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

Treatment: Drugs: Adagrasib
Adagrasib 600 mg BID monotherapy (Cohort 1b)

Treatment: Drugs: Adagrasib
adagrasib 400 mg BID in combination with pembrolizumab

Treatment: Drugs: Adagrasib
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg IV Q3W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Timepoint [1] 0 0
22 months
Primary outcome [2] 0 0
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
Timepoint [2] 0 0
36 months
Secondary outcome [1] 0 0
Phase 2: To characterize the safety and tolerability of study treatments in selected populations
Timepoint [1] 0 0
22 months
Secondary outcome [2] 0 0
Phase 2: Duration of Response
Timepoint [2] 0 0
22 months
Secondary outcome [3] 0 0
Phase 2: Progression Free Survival
Timepoint [3] 0 0
22 months
Secondary outcome [4] 0 0
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Phase 2: To evaluate secondary efficacy endpoints using the study treatment in selected populations
Timepoint [5] 0 0
22 months
Secondary outcome [6] 0 0
Phase 2: To evaluate the pharmacokinetics (PK) of study treatments by measuring blood plasma MRTX849 and potential metabolite concentrations.
Timepoint [6] 0 0
22 months
Secondary outcome [7] 0 0
Phase 3: To evaluate the safety and tolerability in the study population
Timepoint [7] 0 0
36 months
Secondary outcome [8] 0 0
Phase 3: To evaluate the PK of adagrasib administered in the study population
Timepoint [8] 0 0
36 months
Secondary outcome [9] 0 0
Phase 3: To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population
Timepoint [9] 0 0
36 months
Secondary outcome [10] 0 0
Phase 3: Progression Free Survival per RECIST 1.1 by Investigator
Timepoint [10] 0 0
36 months
Secondary outcome [11] 0 0
Phase 3: Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR
Timepoint [11] 0 0
36 months
Secondary outcome [12] 0 0
Phase 3: Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR
Timepoint [12] 0 0
36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2029
Actual
Sample size
Target
806
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Ballarat Regional Integrated Cancer Center - Ballarat
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Local Institution - 007-004 - Clayton
Recruitment hospital [4] 0 0
Local Institution - 007-006 - Garran
Recruitment hospital [5] 0 0
Cancer Care Wollongong - Wollongong
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Philippines
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Cebu City
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Philippines
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Iloilo City
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Philippines
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Makati City
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Philippines
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Molo
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Philippines
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Quezon City
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Gdansk
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Kielce
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Lublin
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Sisli
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Edinburgh
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Kent
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Manchester
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mirati Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04613596