AzTrials
AzTrials

Advanced CancerPhase 2NCT05853575

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

A Phase 2 study testing Adagrasib in people with Advanced Cancer and Metastatic Cancer, run by Mirati Therapeutics Inc. at 98 sites in 18 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adagrasib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
98 sitesin 18 countries
Study dates
1 Feb 2024to 30 Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
  • Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
  • Have recovered from their prior treatment and blood tests are within a safe range.

Who cannot join

  • Have had previous treatment with a drug that targets KRAS G12C.
  • Have cancer that can potentially be removed with surgery.
  • Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mg daily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
  • Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.

Trial locations and contacts

98 sites in 18 countries.

98 sites in 18 countries

France13 sites

  • Local Institution - 554

    Angers, Maine-et-Loire, 49933

  • Local Institution - 559

    Grenoble, Auvergne-Rhône-Alpes, 0

  • Local Institution - 552

    Lorient, Morbihan, 56322

  • Local Institution - 551

    Marseille, Rhône, 13915

  • Local Institution - 555

    Nantes, Pays de la Loire Region, 44093

  • Local Institution - 561

    Nice, Provence-Alpes-Côte d'Azur Region, 06000

  • Local Institution - 562

    Paris, 75014

  • Local Institution - 556

    Pessac, Gironde, 33604

  • Local Institution - 557

    Poitiers, Poitou-Charentes, 86000

  • Local Institution - 558

    Quimper, 29000

  • Local Institution - 553

    Saint-Herblain, Loire-Atlantique, 44800

  • Local Institution - 550

    Saint-Mandé, 94163

  • Local Institution - 560

    Villefranche-sur-Saône, Rhône, 69655

Other trials in France

Spain12 sites

  • Local Institution - 683

    Barcelona, 08025

  • Local Institution - 687

    Barcelona, 08028

  • Local Institution - 681

    Barcelona, 08035

  • Local Institution - 675

    Madrid, 28007

  • Local Institution - 679

    Madrid, 28033

  • Local Institution - 688

    Madrid, 28040

  • Local Institution - 678

    Málaga, Andalusia, 29010

  • Local Institution - 676

    Oviedo, Principality of Asturias, 33011

  • Local Institution - 685

    Palma de Mallorca, Balearic Islands, 07120

  • Local Institution - 680

    Santiago de Compostela, A Coruña, 15706

  • Local Institution - 682

    Seville, 41009

  • Local Institution - 677

    Valencia, 46010

Other trials in Spain

Turkey (Türkiye)10 sites

  • Local Institution - 705

    Ankara, Ankara/Cankaya, 06520

  • Local Institution - 702

    Ankara, Etlik/Ankara, 06010

  • Local Institution - 704

    Ankara, 06200

  • Local Institution - 701

    Ankara, 06680

  • Local Institution - 706

    Ankara, 06800

  • Local Institution - 700

    Edirne, 22030

  • Local Institution - 709

    Istanbul, Samsun, 34214

  • Local Institution - 710

    Istanbul, Samsun, 34846

  • Local Institution - 707

    Istanbul, 34722

  • Local Institution - 708

    Izmir, 35100

Other trials in Turkey (Türkiye)

Romania8 sites

  • Local Institution - 732

    Cluj-Napoca, Cluj, 400641

  • Local Institution - 729

    Craiova, Dolj, 200385

  • Local Institution - 734

    Craiova, Dolj, 200746

  • Local Institution - 733

    Iași, 700106

  • Local Institution - 731

    Ovidiu, Constanța County, 905900

  • Local Institution - 725

    Sibiu, 550245

  • Local Institution - 728

    Suceava, 720214

  • Local Institution - 730

    Timișoara, Timiș County, 300166

Other trials in Romania

Brazil6 sites

  • Local Institution - 178

    Belo Horizonte, São Paulo, 30360-680

  • Local Institution - 182

    Itajaí, Santa Catarina, 88301-220

  • Local Institution - 177

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 181

    Salvador, Estado de Bahia, 41950-640

  • Local Institution - 102

    São Paulo, 01509-900

  • Local Institution - 175

    São Paulo, 01509-900

Other trials in Brazil

Greece6 sites

  • Local Institution - 575

    Athens, Attica, 11528

  • Local Institution - 579

    Haidari - Athens, Pella, 12462

  • Local Institution - 577

    Pátrai, Achaïa, 265 04

  • Local Institution - 580

    Thessaloniki, North Aegean, 552 36

  • Local Institution - 576

    Thessaloniki, 54639

  • Local Institution - 581

    Thessaloniki, 56429

Other trials in Greece

Italy6 sites

  • Local Institution - 780

    Candiolo, Torino, 10060

  • Local Institution - 779

    Milan, 20141

  • Local Institution - 777

    Novara, Piedmont, 28100

  • Local Institution - 775

    Perugia, 6132

  • Local Institution - 778

    Pesaro, Pesaro E Urbino, 61122

  • Local Institution - 776

    Roma, 00144

Other trials in Italy

Israel5 sites

  • Local Institution - 629

    Haifa, Tel Aviv, 31048

  • Local Institution - 627

    Haifa, 3109601

  • Local Institution - 625

    Jerusalem, Jerusalem, 9103102

  • Local Institution - 628

    Tel Aviv, Tel Aviv, 64239

  • Local Institution - 626

    Tel Aviv, 6423906

Other trials in Israel

United States4 sites

  • Local Institution - 106

    Dallas, Texas, 75216-7167

  • Local Institution - 100

    Durham, North Carolina, 27705

  • Local Institution - 105

    Kansas City, Missouri, 64128

  • Local Institution - 101

    Santa Rosa, California, 95403

Other trials in United States

Japan4 sites

  • Local Institution - 402

    Kashiwa, Tiba [Chiba], 277-8577

  • Local Institution - 403

    Nishinomiya, Hyôgo [Hyogo], 663-8501

  • Local Institution - 400

    Osaka, Ôsaka [Osaka], 541-8567

  • Local Institution - 401

    Tōon, Ehime, 791-0295

Other trials in Japan

South Korea4 sites

  • Local Institution - 327

    Goyang-si, Gyeonggido [Kyonggi-do], 10408

  • Local Institution - 325

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351

  • Local Institution - 328

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06273

  • Local Institution - 326

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 08308

Other trials in South Korea

Taiwan4 sites

  • Local Institution - 352

    Kaohsuing City, Kaohsiung, 833401

  • Local Institution - 353

    Taichung, Taichung, 402306

  • Local Institution - 179

    Taichung, Taichung, 404327

  • Local Institution - 350

    Taichung, Taichung, 404327

Other trials in Taiwan

Thailand4 sites

  • Local Institution - 377

    Bangkok, Krung Thep Maha Nakhon [Bangko, 10700

  • Local Institution - 375

    Khon Kaen, 40002

  • Local Institution - 376

    Muang, Chiang Mai, 50200

  • Local Institution - 378

    Songkhla, 90110

Other trials in Thailand

Mexico3 sites

  • Local Institution - 129

    Colonia Nápoles, Mexico City, 3810

  • Local Institution - 127

    Colonia Roma, Mexico City, 06760

  • Local Institution - 125

    Toluca, 50090

Other trials in Mexico

Poland3 sites

  • Local Institution - 651

    Gdynia, Pomeranian Voivodeship, 81-519

  • Local Institution - 650

    Krakow, Lesser Poland Voivodeship, 30-727

  • Local Institution - 653

    Lublin, 20-064

Other trials in Poland

Croatia2 sites

  • Local Institution - 529

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Local Institution - 527

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Netherlands2 sites

  • Local Institution - 800

    Amsterdam, North Holland, 1066 CX

  • Local Institution - 801

    Utrecht, 3543 AZ

Other trials in Netherlands

Serbia2 sites

  • Local Institution - 752

    Kragujevac, Šumadijski Okrug, 34000

  • Local Institution - 754

    Nis, Vojvodina, 11000

Other trials in Serbia

About this study

Official title: A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Read the detailed description

CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Being tested
Adagrasib
Keywords
KRAS G12C, Non-small cell lung cancer, Metastatic cancer, NSCLC
Medical subject headings
Neoplasm Metastasis, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdagrasibDrug

    Also called MRTX849, Krazati

    KRAS G12C inhibitor

Study groups in NCT05853575
Study groupRoleWhat they receive
Adagrasib 600mg BIDExperimentalAdagrasib 600mg BID without regard to food
Receives: Drug: Adagrasib
Adagrasib 400mg BIDExperimentalAdagrasib 400mg BID with food
Receives: Drug: Adagrasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.

    Measured: 30 months

Secondary outcomes (7)

  1. Evaluate Overall Survival (OS).

    Overall survival is defined as time from date of randomization to date of death due to any cause.

    Measured: 45 months

  2. Evaluate Progression Free Survival (PFS).

    Progression-free survival is defined as time from date of randomization to date of first progression per RECIST 1.1 or death from any cause, whichever occurs first.

    Measured: 30 months

  3. Evaluate Duration of Response (DOR).

    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 PD (per BICR review) or death due to any cause, whichever occurs first.

    Measured: 30 months

  4. Safety and tolerability in the study population.

    Safety characterized by number of participants with AEs, with abnormal laboratory test results and number of patients modifying or discontinuing study treatment due to an AE:

    1. Type, incidence, severity, timing, seriousness, and relationship to study treatment of Adverse Events.
    2. Laboratory abnormalities as measured by changes in lab results such as hematologic or chemistry parameters while on study treatment.
    3. Number of patients modifying or discontinuing study treatment due to Adverse Event.

    Measured: 30 months

  5. Population pharmacokinetic (PK) Model Derived Area Under the Curve During the Dosing Interval at Steady State (AUCtau,ss).

    Sparse concentration data from this study will be pooled with other studies and analyzed using population PK methods to derive individual exposure parameters. Data for this Outcome Measure will not be reported here since ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

    Measured: Pre-dose and 4-6 hours post dose; up to 6 months.

  6. Patient-reported symptoms during adagrasib administration from first dose to 28 days after last dose of adagrasib.

    Patient reported outcomes (PROs) will be used to assess symptomatic toxicity of adagrasib using the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Measurement System. PRO items reflect the specific symptom 1) frequency, severity, interference with usual or daily activities, 2) amount, or 3) presence or absence. PRO-CTCAE responses are scored from 0 (low) to 4 (high), or 0/1 for absent/present, and scores for each attribute (frequency, severity and/or interference) are presented descriptively.

    Measured: 30 months

  7. Patient -reported quality of life during adagrasib administration from first dose to End of Treatment visit.

    Patient reported quality of life questionnaire will be used to assess five dimensions of patient health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using the 5-Level EQ-5D version (EQ-5D-5L) established by the EuroQol Group. This is presented descriptively, and patient responses correspond to a value of 1 (low) or 5 (high). Additionally, a one- page Visual Analog Scale (VAS) will be provided to patients so they may report their self-rated health from the best (100) and worst (0) health imaginable.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start1 Feb 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853575
Sponsor's protocol ID
CA239-0012
Other IDs
2023-503523-25, CA239-0012, 849-021, 2023
Status last verified
Aug 2026
First submitted
12 Apr 2023
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adagrasib in people with Advanced Cancer and Metastatic Cancer, run by Mirati Therapeutics Inc. at 98 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in France, Spain, Turkey (Türkiye), Romania, Brazil and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in