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New combo aims to stop KRAS-Mutant lung cancer from coming back

NCT ID NCT07431827

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 15, 2026 · Updated 16 times

Summary

This Phase 3 trial is testing whether adding an experimental drug called calderasib (MK-1084) to standard immunotherapy (pembrolizumab) can keep non-small cell lung cancer from returning after surgery. The study enrolls 400 people with a specific KRAS G12C mutation whose cancer was completely removed. Participants receive either the drug combination or a placebo plus immunotherapy, and researchers will track how long they remain cancer-free.

What this could mean

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

Active substance
Calderasib (MK-1084) oral tablet plus pembrolizumab and hyaluronidase injection
What this could lead to
If successful, this combination could help prevent lung cancer from returning after surgery in people with a specific KRAS mutation.
What could go wrong
This is an early-stage Phase 3 trial with no results yet. The added drug may cause side effects or not improve outcomes over standard treatment.

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

About 400 people

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

Started

Mar 2026

Expected to finish

Oct 2039

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: * Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria: * Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC * Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy. * Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation * No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention. * Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention * Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable Exclusion Criteria: * Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention * Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption) * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has not adequately recovered from major surgery or has ongoing surgical complications

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0414)

    RECRUITING

    Vitória, Espírito Santo, 29043-260, Brazil

  • Adana Medical Park Seyhan Hastanesi ( Site 1827)

    RECRUITING

    Adana, 1140, Turkey (Türkiye)

  • Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825)

    RECRUITING

    Ankara, 06280, Turkey (Türkiye)

  • Ankara Bilkent Şehir Hastanesi ( Site 1811)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center ( Site 3600)

    RECRUITING

    Seoul, 05505, South Korea

  • Athens Medical Center ( Site 1202)

    RECRUITING

    Athens, Attica, 151 25, Greece

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1812)

    RECRUITING

    Adana, 01250, Turkey (Türkiye)

  • Beijing Cancer hospital ( Site 2106)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0216)

    RECRUITING

    Chicoutimi, Quebec, G7H 5H6, Canada

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)

    RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Centre Hospitalier de l'Université de Montréal ( Site 0219)

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Centre de Cancérologie du Grand Montpellier ( Site 1016)

    RECRUITING

    Montpellier, Languedoc-Roussillon, 34070, France

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)

    RECRUITING

    CABA, C1431FWO, Argentina

  • Centro de Oncología de Precisión ( Site 0503)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Chongqing University Three Gorges Hospital ( Site 2138)

    RECRUITING

    Chongqing, Chongqing Municipality, 404199, China

  • Clínica MEDS La Dehesa ( Site 0509)

    RECRUITING

    Lo Barnechea, Region M. de Santiago, 7691236, Chile

  • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)

    RECRUITING

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)

    RECRUITING

    Lviv, Lviv Oblast, 79031, Ukraine

  • Errikos Dunant Hospital Center ( Site 1201)

    RECRUITING

    Athens, Attica, 115 26, Greece

  • Evangelismos General Hospital of Athens ( Site 1204)

    RECRUITING

    Athens, Attica, 106 76, Greece

  • FALP ( Site 0501)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0601)

    RECRUITING

    Bogota, Cundinamarca, 110131, Colombia

  • Faculdade de Medicina do ABC ( Site 0415)

    RECRUITING

    Santo André, São Paulo, 09060-870, Brazil

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)

    RECRUITING

    Roma, 00168, Italy

  • Fourth Hospital Of Hebei Medical University ( Site 2107)

    RECRUITING

    Hshijiazhuang, Hebei, 050010, China

  • Fudan University Shanghai Cancer Center ( Site 2137)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital ( Site 2122)

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fukushima Medical University Hospital ( Site 2202)

    RECRUITING

    Fukushima, 960-1295, Japan

  • G. Papanikolaou General Hospital ( Site 1203)

    RECRUITING

    Thessaloniki, Central Macedonia, 570 10, Greece

  • Guangxi Medical University Cancer Hospital ( Site 2115)

    RECRUITING

    Nanning, Guangxi, 530200, China

  • H.R.U Malaga - Hospital General ( Site 1708)

    RECRUITING

    Málaga, 29010, Spain

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707)

    RECRUITING

    Madrid, 28223, Spain

  • Hacettepe Universite Hastaneleri ( Site 1810)

    RECRUITING

    Ankara, 06410, Turkey (Türkiye)

  • Hospital Alemao Oswaldo Cruz ( Site 0416)

    RECRUITING

    São Paulo, 01327-001, Brazil

  • Hospital Clinico San Carlos ( Site 1706)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Insular de Gran Canaria ( Site 1704)

    RECRUITING

    Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

  • Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306)

    RECRUITING

    CABA, C1199ABB, Argentina

  • Hospital Puerta de Hierro ( Site 1705)

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitari Vall d'Hebron ( Site 1700)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena ( Site 1709)

    RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario la Paz ( Site 1710)

    RECRUITING

    Madrid, 28046, Spain

  • Institut Català d'Oncologia (ICO) - Girona ( Site 1703)

    RECRUITING

    Girona, Gerona, 17007, Spain

  • Instituto Alexander Fleming ( Site 0310)

    RECRUITING

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Instituto Médico de Alta Tecnología S.A.S. ( Site 0605)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826)

    RECRUITING

    Istanbul, 34865, Turkey (Türkiye)

  • Keimyung University Dongsan Hospital ( Site 3605)

    RECRUITING

    Daegu, Taegu-Kwangyokshi, 42601, South Korea

  • Liv Hospital Ankara ( Site 1828)

    RECRUITING

    Ankara, 6680, Turkey (Türkiye)

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

    RECRUITING

    Lviv, Lviv Oblast, 79059, Ukraine

  • ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)

    RECRUITING

    Rivne, Rivne Oblast, 33010, Ukraine

  • Mackay Memorial Hospital ( Site 3701)

    RECRUITING

    Taipei, 10449, Taiwan

  • Medical Center "Mriya Med-Service" ( Site 1911)

    RECRUITING

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)

    RECRUITING

    Kyiv, 03057, Ukraine

  • Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824)

    RECRUITING

    Mersin, 33240, Turkey (Türkiye)

  • Metaxa Cancer Hospital of Piraeus ( Site 1207)

    RECRUITING

    Piraeus, Attica, 185 37, Greece

  • Moncton Hospital ( Site 0200)

    RECRUITING

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)

    RECRUITING

    Lutsk, Volyn Oblast, 43018, Ukraine

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)

    RECRUITING

    Odesa, Odesa Oblast, 65025, Ukraine

  • National Cancer Center ( Site 3603)

    RECRUITING

    Goyang-si, Kyonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital ( Site 3706)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Cancer Center (NTUCC) ( Site 3707)

    RECRUITING

    Taipei, 106, Taiwan

  • Ningbo No. 2 Hospital ( Site 2124)

    RECRUITING

    Ningbo, Zhejiang, 315010, China

  • Northern Beaches Hospital ( Site 3009)

    RECRUITING

    Frenchs Forest, New South Wales, 2086, Australia

  • Oncologos Del Occidente ( Site 0606)

    RECRUITING

    Pereira, Risaralda Department, 661001, Colombia

  • PRONUTRIR ( Site 0425)

    RECRUITING

    Fortaleza, Ceará, 60810-180, Brazil

  • Peking Union Medical College Hospital ( Site 2105)

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Peking University People's Hospital ( Site 2100)

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Peninsula University Hospital ( Site 3011)

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

  • Queen Alexandra Hospital ( Site 2011)

    RECRUITING

    Portsmouth, PO6 3LY, United Kingdom

  • Queen Mary Hospital ( Site 3100)

    RECRUITING

    Hong Kong, Hong Kong

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 1816)

    RECRUITING

    Rize, 53020, Turkey (Türkiye)

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)

    RECRUITING

    Chernivtsi, Chernivetska Oblast, 58013, Ukraine

  • Sakarya Egitim ve Arastırma Hastanesi ( Site 1817)

    RECRUITING

    Sakarya, 54100, Turkey (Türkiye)

  • Sanatorio Parque ( Site 0311)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Severance Hospital Yonsei University Health System ( Site 3601)

    RECRUITING

    Seoul, 03722, South Korea

  • Shalimov Institute of Surgery and Transplantation ( Site 1907)

    RECRUITING

    Kyiv, 03126, Ukraine

  • Shanghai Pulmonary Hospital ( Site 2125)

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Sichuan Cancer hospital ( Site 2101)

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 2118)

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Sun Yat-sen University Cancer Center ( Site 2134)

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1206)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Taipei Medical University Shuang Ho Hospital ( Site 3700)

    RECRUITING

    New Taipei City, 235, Taiwan

  • The Affiliated Cancer Hospital of Xinjiang Medical ( Site 2110)

    RECRUITING

    Urumuqi, Xinjiang, 830054, China

  • The Catholic University of Korea St. Vincent s Hospital ( Site 3602)

    RECRUITING

    Suwon, Kyonggi-do, 16247, South Korea

  • The First Affiliated Hospital Of Fujian Medical University ( Site 2123)

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Nanchang University ( Site 2121)

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • The Third Peoples Hospital Of Chengdu ( Site 2141)

    RECRUITING

    Chengdu, Sichuan, 610031, China

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 2103)

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 2140)

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Tri-Service General Hospital ( Site 3708)

    RECRUITING

    Taipei, 11490, Taiwan

  • Tuen Mun Hospital ( Site 3102)

    RECRUITING

    Hong Kong, Hong Kong

  • Ukrainian Center of Tomotherapy ( Site 1917)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139)

    RECRUITING

    Wuhan, Hubei, 430048, China

  • West China Hospital, Sichuan University ( Site 2142)

    RECRUITING

    Chengdu, Sichuan, 610000, China

  • Xiangya Hospital Central South University ( Site 2136)

    RECRUITING

    Changsha, Hunan, 410008, China

  • Yunnan Province Cancer Hospital ( Site 2131)

    RECRUITING

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital ( Site 2117)

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital of Fudan University ( Site 2119)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815)

    RECRUITING

    Malatya, 44280, Turkey (Türkiye)

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