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New pill could outperform current KRAS lung cancer drugs

NCT ID NCT06497556

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 2 times

Summary

This phase 3 trial compares a new drug, divarasib, to two existing targeted therapies (sotorasib and adagrasib) in 338 people with advanced or metastatic non-small cell lung cancer that has a specific KRAS G12C mutation and has progressed after prior treatment. Participants take one of the drugs as a pill daily or twice daily. The study measures how long the cancer stays under control and overall survival.

What this could mean

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

Active substance
Divarasib (a targeted cancer drug taken as a pill)
What this could lead to
If successful, divarasib could offer a more effective treatment option for people with a specific type of advanced lung cancer (KRAS G12C mutation).
What could go wrong
This is an early-stage comparison trial; divarasib may not prove better than existing drugs, and side effects are possible. Results may not apply to all lung cancer patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

338 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Nov 2029

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.

Inclusion Criteria: * Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation * Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Documentation of the presence of a KRAS G12C mutation * Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of \>= 12 weeks Exclusion Criteria: * Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib * Malabsorption syndrome or other condition that would interfere with enteral absorption * Known concomitant second oncogenic driver * Mixed small-cell lung cancer or large cell neuroendocrine histology * Known and untreated, or active central nervous system (CNS) metastases * Leptomeningeal disease or carcinomatous meningitis * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently * Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1 * Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor * More than 30 Gy of radiotherapy to the lung within 6 months of randomization * Uncontrolled tumor-related pain * Unresolved toxicities from prior anticancer therapy * History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

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Conditions

The condition(s) this trial relates to.

lung carcinoma lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

KRAS G12C lung cancer Non-small cell lung cancer

Contacts and locations

Locations

  • A.O. Universitaria Di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • ARKE Estudios Clínicos S.A. de C.V.

    Mexico City, 06700, Mexico

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800, Belgium

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300, Belgium

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Ag. Loukas Hospital

    Thessaloniki, 55236, Greece

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212, United States

  • Amphia Ziekenhuis

    Breda, 4818CK, Netherlands

  • Asklepios Fachkliniken GmbH

    Gauting, 82131, Germany

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50139, Italy

  • Banner Health MD Anderson AZ

    Gilbert, Arizona, 85234, United States

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120, United States

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • CH de Saint Quentin

    Saint-Quentin, 2100, France

  • CHRU Brest

    Brest, 29200, France

  • CHRU Lille

    Lille, 59037, France

  • CHU Bordeaux

    Pessac, 33604, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530, Belgium

  • CHU de Liège (Sart Tilman)

    Liège, 4000, Belgium

  • CHUC - Unidade de Pneumologia Oncológica

    Coimbra, 3000-075, Portugal

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Castle Hill Hospital

    Cottingham, HU16 5JQ, United Kingdom

  • Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

    Nice, 06100, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centro Clinico Champalimaud

    Lisbon, 1400-038, Portugal

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001, Portugal

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chru de Strasbourg

    Strasbourg, 67091, France

  • Chu Toulouse

    Bron, 69500, France

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dolno?L?Skie Centrum Onkologii, Pulmonologii I Hematologii

    Wroc?aw, 53-439, Poland

  • Errikos Dynan Hospital

    Athens, 11526, Greece

  • Evangelische Lungenklinik Berlin

    Berlin, 13125, Germany

  • Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)

    St. Petersburg, Florida, 33701-4553, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • GenesisCare North Shore

    St Leonards, New South Wales, 2065, Australia

  • Guy's Hospital - Cancer Centre

    London, SE1 9RT, United Kingdom

  • Gävle Sjukhus

    Gävle, 80187, Sweden

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165, Germany

  • Helsinki University Central Hospital

    Helsinki, 00029, Finland

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hia Sainte Anne

    Toulon, 83041, France

  • Hopital Louis Pradel

    Bron, 69677, France

  • Hopital Tenon

    Paris, 75970, France

  • Hospital Alemao Oswaldo Cruz

    São Paulo, São Paulo, 01323-903, Brazil

  • Hospital Britanico

    Buenos Aires, C1280AEB, Argentina

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Nuestra Senora de Valme

    Seville, Sevilla, 41014, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital Vall Hebron

    Barcelona, Spain

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • IRCCS Istituto Regina Elena (IFO)

    Rome, Lazio, 00144, Italy

  • Institut Catala d Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Instytut Gruzlicy I Chorob Pluc

    Warsaw, 01-138, Poland

  • Irccs Ist. Tumori Giovanni Paolo Ii

    Bari, Apulia, 70124, Italy

  • Isala

    Zwolle, 8025 AB, Netherlands

  • JPS Health Network

    Fort Worth, Texas, 76104, United States

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500, Belgium

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    Essen, 45136, Germany

  • Kindai University Hospital

    Osaka, 590-0197, Japan

  • Klinikum Bogenhausen

    München, 81925, Germany

  • Klinikum Esslingen

    Esslingen am Neckar, 73730, Germany

  • Klinikum Koeln-Merheim

    Cologne, 51109, Germany

  • Klinikum Würzburg Mitte gGmbH

    Würzburg, 97074, Germany

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210, Austria

  • Kuopio Uni Hospital

    Kuopio, 70211, Finland

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Los Angeles Cancer Network

    Los Angeles, California, 90017-4803, United States

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lungenklinik Hemer

    Hemer, 58675, Germany

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112, Australia

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medisch Centrum Haaglanden, locatie Antoniushove

    Leidschendam, 2262 BA, Netherlands

  • Minnesota Oncology Edina

    Edina, Minnesota, 55435, United States

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Taiwan University Hospital

    Taipei, 00100, Taiwan

  • New England Cancer Specialists

    Westbrook, Maine, 04092, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Oncology Associates of Oregon, P.C

    Eugene, Oregon, 97401, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Ospedale Civile SS Annunziata

    Sassari, Sardinia, 07100, Italy

  • Ospedale Policlinico San Martino

    Genoa, Liguria, 16132, Italy

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hosp

    Shatin, Hong Kong

  • Regionshospitalet Gødstrup

    Herning, 7400, Denmark

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT, United Kingdom

  • Royal Marsden Hospital - London

    London, SW3 6JJ, United Kingdom

  • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein

    Löwenstein, 74245, Germany

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC - Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Texas Oncology - Northeast Texas

    Longview, Texas, 75601, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • Theageneio Hospital

    Thessaloniki, 546 39, Greece

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Torbay Hospital

    Torquay, TQ27AA, United Kingdom

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • UCLA Hematology / Oncology Clinic

    Los Angeles, California, 90095, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • UZ Brussel

    Brussels, 1090, Belgium

  • University Hospital of Larissa

    Larissa, 411 10, Greece

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109-0934, United States

  • Universität Des Saarlandes

    Homburg, 66421, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie

    Münster, 48149, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538, Germany

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214, Poland

  • Uoa Sotiria Hospital

    Athens, 115 27, Greece

  • Vajira Hospital

    Bangkok, 10300, Thailand

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • Wakayama Medical University Hospital

    Wakayama, 641-8510, Japan

  • William Osler Health Centre - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • Yale Cancer Center

    New Haven, Connecticut, 06519, United States

  • ZAS Sint Augustinus Wilrijk

    Wilrijk, 2610, Belgium

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD, Netherlands

  • Ziekenhuis St. Jansdal

    Harderwijk, 3844 DG, Netherlands

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