Comparing 5 approaches for advanced non-small cell lung cancer
Official 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
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
- Phase 2
- 5 groups
- Sites in Edmonton, Vancouver and 4 more cities
- Recruiting
Interventions (5)
- Medication
Adagrasib
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
- Medication
Adagrasib
Adagrasib 600 mg BID monotherapy (Cohort 1b)
- Medication
Adagrasib
adagrasib 400 mg BID in combination with pembrolizumab
- Medication
Adagrasib
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
- Medication
Pembrolizumab
Pembrolizumab 200 mg IV Q3W
Canadian Sites (6)
4 of 6 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
- Recruiting
British Columbia Cancer Agency - Vancouver
Vancouver, British Columbia
- Recruiting
Ottawa Hospital - General Campus
Ottawa, Ontario
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Withdrawn
Local Institution - 007-489
London, Ontario
- Not currently recruiting
Local Institution - 007-490
Montreal, Quebec
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
- +Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
- +No evidence of brain metastases
- +Untreated brain metastases not needing immediate local therapy
- +Previously treated brain metastases not needing immediate local therapy
- +Phase 3: Presence of measurable disease per RECIST1.1
- +Phase 3: CNS InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → - Based on screeningScreeningThe checks done before joining, to see whether a study fits.Read more → brain imaging, patients must have one of the following:
Exclusion
- −Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Active brain metastases
- −Any untreated brain lesions \> 2.0 cm in size
- −Ongoing use of systemic corticosteroids for controlControl groupThe group a new treatment is measured against.Read more → of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
- −Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: Patients with known central nervous system (CNS) lesions must not have any of the following:
- −Any brainstem lesions
- −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 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 5 groups in this study.
Groups A, B, C and D receive Adagrasib.
Registry label: A: Phase 2 Cohort 1a: PD-L1 TPS <1% · B: Phase 2 Cohort 1b: PD-L1 TPS <1% · C: Phase 2 Cohort 2: PD-L1 TPS ≥1% · D: Phase 3 Cohort 3 Investigational Arm
Group E, the comparison group, receives Pembrolizumab.
Registry label: E: Phase 3 Cohort 4 Comparator Arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 626 people.
The study is currently expected to finish around October 2029.
The main measurement is taken over: 22 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC — measured over 22 months.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab — measured over 36 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04613596 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AdagrasibDrug
Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AdagrasibDrug
Adagrasib 600 mg BID monotherapy (Cohort 1b)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AdagrasibDrug
adagrasib 400 mg BID in combination with pembrolizumab
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AdagrasibDrug
Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
Pembrolizumab 200 mg IV Q3W
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 22 months.
The study as a whole is currently expected to finish around 2029-10-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 626 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (9)
USOR - Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Local Institution - 007-589A
Edina, Minnesota, United States
Local Institution - Unk006
Minneapolis, Minnesota, United States
Local Institution - 007-822
Minneapolis, Minnesota, United States
Local Institution - 007-830
Rochester, Minnesota, United States
New York Oncology Hematology - Albany Medical Center
Albany, New York, United States
Local Institution - Unk077
Rhinebeck, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.