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New hope for lung cancer patients with a specific gene mutation

NCT ID NCT05789082

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Updated 6 times

Summary

This study tests a drug called divarasib, either alone or with other cancer treatments, in people with advanced lung cancer that has a specific genetic change (KRAS G12C). The goal is to see if the drug is safe and works to shrink or control the cancer. About 320 people who have not had treatment before will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 320 people

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

Started

Jun 2023

Expected to finish

Jan 2032

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: * Confirmation of Biomarker eligibility * Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy * No prior systemic treatment for advanced unresectable or metastatic NSCLC * Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment. Exclusion Criteria: * Known concomitant second oncogenic driver with available targeted treatment * Squamous cell histology NSCLC * Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C) * Prior treatment with a KRAS G12C inhibitor * Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only) * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment * History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer * Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia * Co-morbid condition that is an absolute contraindication to treatment with corticosteroids * Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation. * Participants with brain metastases for whom complete surgical resections is clinically appropriate

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    55 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O. Universitaria S. Luigi Gonzaga

    RECRUITING

    Orbassano, Piedmont, 10043, Italy

  • AZ Delta (Campus Rumbeke)

    RECRUITING

    Roeselare, 8800, Belgium

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Barts & London School of Med

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Centro Oncologico Riojano Integral (CORI)

    RECRUITING

    La Rioja, F5300COE, Argentina

  • Chang Gung Medical Foundation - Linkou

    RECRUITING

    Taoyuan, 333, Taiwan

  • City of Hope - Long Beach Elm

    WITHDRAWN

    Long Beach, California, 90813, United States

  • City of Hope - Seacliff

    WITHDRAWN

    Huntington Beach, California, 92648, United States

  • City of Hope National Medical Center

    WITHDRAWN

    Duarte, California, 91010, United States

  • City of Hope at Irvine Lennar

    WITHDRAWN

    Irvine, California, 92618, United States

  • Clinica Adventista Belgrano

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

  • Clinique Ste-Elisabeth

    RECRUITING

    Namur, 5000, Belgium

  • Cliniques Universitaires St-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Concord Repatriation General Hospital

    COMPLETED

    Concord, New South Wales, 2139, Australia

  • Florida Cancer Specialists - EAST - SCRI - PPDS

    RECRUITING

    West Palm Beach, Florida, 33401-3406, United States

  • Florida Cancer Specialists - NORTH - SCRI - PPDS

    RECRUITING

    St. Petersburg, Florida, 33705-1400, United States

  • Florida Cancer Specialists - SOUTH - SCRI - PPDS

    RECRUITING

    Fort Myers, Florida, 33901-8108, United States

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, 150081, China

  • Hospital Britanico

    RECRUITING

    Buenos Aires, C1280AEB, Argentina

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital de Cancer de Barretos

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Hunan Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Changsha, 410013, China

  • ICO Badalona-H.U. Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Inselspital Bern

    WITHDRAWN

    Bern, 3010, Switzerland

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    RECRUITING

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Istituto Nazionale Dei Tumori (Int)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale

    WITHDRAWN

    Naples, Campania, 80131, Italy

  • Jessa Zkh (Campus Virga Jesse)

    RECRUITING

    Hasselt, 3500, Belgium

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Kindai University Hospital

    RECRUITING

    Osaka, 589-8511, Japan

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    RECRUITING

    Krakow, 31-202, Poland

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Montefiore Medical Center - Montefiore Medical Park

    RECRUITING

    The Bronx, New York, 10461, United States

  • Mount SInai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • NKI The Netherlands Cancer Institute

    ACTIVE_NOT_RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • NYU Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • National Cancer Center Hospital

    COMPLETED

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, Taiwan

  • National Taiwan Uni Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Oncology & Hematology Associates of Southwest Virginia, Inc

    RECRUITING

    Blacksburg, Virginia, 24060, United States

  • Ottawa Hospital Regional Cancer Centre

    RECRUITING

    Ottawa, Ontario, K1H 8M2, Canada

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario Agostino Gemelli IRCCS

    ACTIVE_NOT_RECRUITING

    Rome, Lazio, 00168, Italy

  • Princess Margaret Cancer Center

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • Rabin MC

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 411 36, Sweden

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Shanghai Pulmonary Hospital

    ACTIVE_NOT_RECRUITING

    Shanghai, 200433, China

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407, Taiwan

  • Tel Aviv Sourasky Medical Ctr

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The Cancer Institute Hospital of JFCR

    WITHDRAWN

    Tokyo, 135-8550, Japan

  • UCSD Moores Cancer Center

    WITHDRAWN

    La Jolla, California, 92093, United States

  • UMC St Radboud

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Universitätsspital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gda?sk, 80-214, Poland

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    RECRUITING

    Barcelona, 08035, Spain

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Wakayama Medical University Hospital

    WITHDRAWN

    Wakayama, 641-8510, Japan

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    RECRUITING

    Olsztyn, 10-357, Poland

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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