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Lung cancer drug adagrasib: which dose works best?

NCT ID NCT05853575

Disease control Sponsor: Mirati Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This phase 2 study compares two dosing schedules of the targeted drug adagrasib (Krazati) in 200 adults with advanced non-small cell lung cancer that has a specific KRAS G12C mutation. Participants have already tried chemotherapy and immunotherapy. The goal is to see if a lower dose taken with food works as well as the standard higher dose, potentially reducing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adagrasib (Krazati), a targeted cancer drug
What this could lead to
If successful, this could identify a more effective or better-tolerated dosing schedule for adagrasib in KRAS G12C lung cancer, improving treatment options.
What could go wrong
This is a phase 2 trial with only 200 participants, so results may not apply to all patients. The drug may cause side effects, and the lower dose might be less effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

cancer lung cancer lung neoplasm metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced cancer Malignant neoplasm of lung Metastatic cancer

Contacts and locations

Locations

  • Local Institution - 100

    Durham, North Carolina, 27705, United States

  • Local Institution - 101

    Santa Rosa, California, 95403, United States

  • Local Institution - 102

    São Paulo, 01509-900, Brazil

  • Local Institution - 105

    Kansas City, Missouri, 64128, United States

  • Local Institution - 106

    Dallas, Texas, 75216-7167, United States

  • Local Institution - 125

    Toluca, 50090, Mexico

  • Local Institution - 127

    Colonia Roma, Mexico City, 06760, Mexico

  • Local Institution - 129

    Colonia Nápoles, Mexico City, 3810, Mexico

  • Local Institution - 175

    São Paulo, 01509-900, Brazil

  • Local Institution - 177

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Local Institution - 178

    Belo Horizonte, São Paulo, 30360-680, Brazil

  • Local Institution - 179

    Taichung, Taichung, 404327, Taiwan

  • Local Institution - 181

    Salvador, Estado de Bahia, 41950-640, Brazil

  • Local Institution - 182

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Local Institution - 325

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

  • Local Institution - 326

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

  • Local Institution - 327

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

  • Local Institution - 328

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

  • Local Institution - 350

    Taichung, Taichung, 404327, Taiwan

  • Local Institution - 352

    Kaohsuing City, Kaohsiung, 833401, Taiwan

  • Local Institution - 353

    Taichung, Taichung, 402306, Taiwan

  • Local Institution - 375

    Khon Kaen, 40002, Thailand

  • Local Institution - 376

    Muang, Chiang Mai, 50200, Thailand

  • Local Institution - 377

    Bangkok, Krung Thep Maha Nakhon [Bangko, 10700, Thailand

  • Local Institution - 378

    Songkhla, 90110, Thailand

  • Local Institution - 400

    Osaka, Ôsaka [Osaka], 541-8567, Japan

  • Local Institution - 401

    Tōon, Ehime, 791-0295, Japan

  • Local Institution - 402

    Kashiwa, Tiba [Chiba], 277-8577, Japan

  • Local Institution - 403

    Nishinomiya, Hyôgo [Hyogo], 663-8501, Japan

  • Local Institution - 527

    Zagreb, City of Zagreb, 10000, Croatia

  • Local Institution - 529

    Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

  • Local Institution - 550

    Saint-Mandé, 94163, France

  • Local Institution - 551

    Marseille, Rhône, 13915, France

  • Local Institution - 552

    Lorient, Morbihan, 56322, France

  • Local Institution - 553

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Local Institution - 554

    Angers, Maine-et-Loire, 49933, France

  • Local Institution - 555

    Nantes, Pays de la Loire Region, 44093, France

  • Local Institution - 556

    Pessac, Gironde, 33604, France

  • Local Institution - 557

    Poitiers, Poitou-Charentes, 86000, France

  • Local Institution - 558

    Quimper, 29000, France

  • Local Institution - 559

    Grenoble, Auvergne-Rhône-Alpes, 0, France

  • Local Institution - 560

    Villefranche-sur-Saône, Rhône, 69655, France

  • Local Institution - 561

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

  • Local Institution - 562

    Paris, 75014, France

  • Local Institution - 575

    Athens, Attica, 11528, Greece

  • Local Institution - 576

    Thessaloniki, 54639, Greece

  • Local Institution - 577

    Pátrai, Achaïa, 265 04, Greece

  • Local Institution - 579

    Haidari - Athens, Pella, 12462, Greece

  • Local Institution - 580

    Thessaloniki, North Aegean, 552 36, Greece

  • Local Institution - 581

    Thessaloniki, 56429, Greece

  • Local Institution - 625

    Jerusalem, Jerusalem, 9103102, Israel

  • Local Institution - 626

    Tel Aviv, 6423906, Israel

  • Local Institution - 627

    Haifa, 3109601, Israel

  • Local Institution - 628

    Tel Aviv, Tel Aviv, 64239, Israel

  • Local Institution - 629

    Haifa, Tel Aviv, 31048, Israel

  • Local Institution - 650

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Local Institution - 651

    Gdynia, Pomeranian Voivodeship, 81-519, Poland

  • Local Institution - 653

    Lublin, 20-064, Poland

  • Local Institution - 675

    Madrid, 28007, Spain

  • Local Institution - 676

    Oviedo, Principality of Asturias, 33011, Spain

  • Local Institution - 677

    Valencia, 46010, Spain

  • Local Institution - 678

    Málaga, Andalusia, 29010, Spain

  • Local Institution - 679

    Madrid, 28033, Spain

  • Local Institution - 680

    Santiago de Compostela, A Coruña, 15706, Spain

  • Local Institution - 681

    Barcelona, 08035, Spain

  • Local Institution - 682

    Seville, 41009, Spain

  • Local Institution - 683

    Barcelona, 08025, Spain

  • Local Institution - 685

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Local Institution - 687

    Barcelona, 08028, Spain

  • Local Institution - 688

    Madrid, 28040, Spain

  • Local Institution - 700

    Edirne, 22030, Turkey (Türkiye)

  • Local Institution - 701

    Ankara, 06680, Turkey (Türkiye)

  • Local Institution - 702

    Ankara, Etlik/Ankara, 06010, Turkey (Türkiye)

  • Local Institution - 704

    Ankara, 06200, Turkey (Türkiye)

  • Local Institution - 705

    Ankara, Ankara/Cankaya, 06520, Turkey (Türkiye)

  • Local Institution - 706

    Ankara, 06800, Turkey (Türkiye)

  • Local Institution - 707

    Istanbul, 34722, Turkey (Türkiye)

  • Local Institution - 708

    Izmir, 35100, Turkey (Türkiye)

  • Local Institution - 709

    Istanbul, Samsun, 34214, Turkey (Türkiye)

  • Local Institution - 710

    Istanbul, Samsun, 34846, Turkey (Türkiye)

  • Local Institution - 725

    Sibiu, 550245, Romania

  • Local Institution - 728

    Suceava, 720214, Romania

  • Local Institution - 729

    Craiova, Dolj, 200385, Romania

  • Local Institution - 730

    Timișoara, Timiș County, 300166, Romania

  • Local Institution - 731

    Ovidiu, Constanța County, 905900, Romania

  • Local Institution - 732

    Cluj-Napoca, Cluj, 400641, Romania

  • Local Institution - 733

    Iași, 700106, Romania

  • Local Institution - 734

    Craiova, Dolj, 200746, Romania

  • Local Institution - 752

    Kragujevac, Šumadijski Okrug, 34000, Serbia

  • Local Institution - 754

    Nis, Vojvodina, 11000, Serbia

  • Local Institution - 775

    Perugia, 6132, Italy

  • Local Institution - 776

    Roma, 00144, Italy

  • Local Institution - 777

    Novara, Piedmont, 28100, Italy

  • Local Institution - 778

    Pesaro, Pesaro E Urbino, 61122, Italy

  • Local Institution - 779

    Milan, 20141, Italy

  • Local Institution - 780

    Candiolo, Torino, 10060, Italy

  • Local Institution - 800

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Local Institution - 801

    Utrecht, 3543 AZ, Netherlands

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