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New hope for KRAS lung cancer: targeted pill plus immunotherapy in Late-Stage trial

NCT ID NCT07554339

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18 times

Summary

This phase 3 trial tests whether adding the targeted pill calderasib (MK-1084) to the immunotherapy durvalumab helps people with a specific KRAS G12C-mutated lung cancer live longer without their cancer growing. About 310 participants who have finished chemotherapy and radiation without progression will receive either the drug combo or a placebo plus durvalumab. The study aims to see if the combination delays cancer progression and improves survival.

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) plus durvalumab
What this could lead to
If successful, this combination could offer a new treatment option to delay cancer growth or spread in people with a specific KRAS-mutated lung cancer.
What could go wrong
This is an early-phase 3 trial, so results are not guaranteed. The drug combination may cause side effects, and the benefit over standard care is uncertain.

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 310 people

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

Started

Jun 2026

Expected to finish

Aug 2037

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: The main inclusion criteria include but are not limited to the following: * Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology. * Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression. * Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research. * Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result. * If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART). * If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy. * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. * Has a body weight ≥35 kg. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements. * Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received prior treatment (other than definitive CCRT) for NSCLC. * Has a 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. * Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids. * Has an active infection requiring systemic therapy. * Has a history of stem cell/solid organ transplant. * 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

    73 sites in 16 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 0416)

    RECRUITING

    Vitória, Espírito Santo, 29043-260, Brazil

  • ALEXANDRA General Hospital of Athens ( Site 1200)

    RECRUITING

    Athens, Attica, 115 28, Greece

  • Ajou University Hospital ( Site 2504)

    RECRUITING

    Suwon, Kyonggi-do, 16499, South Korea

  • Anhui Provincial Cancer Hospital ( Site 2209)

    RECRUITING

    Hefei, Anhui, 230031, China

  • Asan Medical Center ( Site 2500)

    RECRUITING

    Seoul, 05505, South Korea

  • Athens Medical Center ( Site 1201)

    RECRUITING

    Athens, Attica, 151 25, Greece

  • Beijing Peking Union Medical College Hospital ( Site 2220)

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Chungbuk National University Hospital ( Site 2502)

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinica Adventista Belgrano ( Site 0304)

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430EGF, Argentina

  • Clinique Teissier Groupe ( Site 1006)

    RECRUITING

    Valenciennes, Nord, 59300, France

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)

    RECRUITING

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

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

  • Erciyes University ( Site 1904)

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

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

    RECRUITING

    Rome, Lazio, 00168, Italy

  • Fourth Hospital of Hebei Medical University ( Site 2201)

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • Fudan University Shanghai Cancer Center ( Site 2216)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fundación Instituto Valenciano de Oncología ( Site 1809)

    RECRUITING

    Valencia, Valenciana, Comunitat, 46009, Spain

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)

    RECRUITING

    Münster, North Rhine-Westphalia, 48153, Germany

  • Guangxi Medical University Cancer Hospital ( Site 2202)

    RECRUITING

    Nanning, Guangxi, 530022, China

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)

    RECRUITING

    Madrid, 28007, Spain

  • Hacettepe Universite Hastaneleri ( Site 1900)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Britanico de Buenos Aires ( Site 0305)

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

  • Hospital Clinico San Carlos ( Site 1810)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario La Paz ( Site 1808)

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Virgen Macarena ( Site 1805)

    RECRUITING

    Seville, 41007, Spain

  • Hubei Cancer Hospital ( Site 2203)

    RECRUITING

    Wuhan, Hubei, 430070, China

  • Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)

    RECRUITING

    Girona, Gerona, 17007, Spain

  • Instituto Alexander Fleming ( Site 0301)

    RECRUITING

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1426ANZ, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Keimyung University Dongsan Hospital ( Site 2503)

    RECRUITING

    Daegu, Taegu-Kwangyokshi, 42601, South Korea

  • Kyiv City Clinical Oncology Center ( Site 2015)

    RECRUITING

    Kyiv, Kyivska Oblast, 03115, Ukraine

  • Leids Universitair Medisch Centrum ( Site 1503)

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Liv Hospital Ankara ( Site 1911)

    RECRUITING

    Ankara, 06680, Turkey (Türkiye)

  • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)

    RECRUITING

    Lviv, Lviv Oblast, 79031, Ukraine

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)

    RECRUITING

    Lviv, Lviv Oblast, 79059, Ukraine

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)

    RECRUITING

    Rivne, Rivne Oblast, 33010, Ukraine

  • Mackay Memorial Hospital ( Site 2611)

    RECRUITING

    Taipei, 10449, Taiwan

  • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)

    RECRUITING

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)

    RECRUITING

    Kyiv, 03057, Ukraine

  • Metaxa Cancer Hospital of Piraeus ( Site 1203)

    RECRUITING

    Piraeus, Attica, 185 37, Greece

  • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)

    RECRUITING

    Odesa, Odesa Oblast, 65025, Ukraine

  • NHO Revive Research Institute LLC ( Site 0118)

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • Nanjing Drum Tower Hospital ( Site 2224)

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • National Cancer Center ( Site 2505)

    RECRUITING

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

  • National Cheng Kung University Hospital ( Site 2601)

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Cancer Center (NTUCC) ( Site 2610)

    RECRUITING

    Taipei, 106, Taiwan

  • New York Oncology Hematology P.C ( Site 9000)

    RECRUITING

    Albany, New York, 12206, United States

  • Northern Beaches Hospital ( Site 2401)

    RECRUITING

    Frenchs Forest, New South Wales, 2086, Australia

  • Princess Alexandra Hospital ( Site 2406)

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

  • Radboudumc ( Site 1504)

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)

    RECRUITING

    Chernivtsi, Chernivetska Oblast, 58013, Ukraine

  • Sanatorio Parque ( Site 0302)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Sendai Kousei Hospital ( Site 2300)

    RECRUITING

    Sendai, Miyagi, 981-0914, Japan

  • Severance Hospital, Yonsei University Health System ( Site 2501)

    RECRUITING

    Seoul, 03722, South Korea

  • Shalimov Institute of Surgery and Transplantation ( Site 2003)

    RECRUITING

    Kyiv, Kyivska Oblast, 03680, Ukraine

  • Shandong Cancer Hospital ( Site 2200)

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital ( Site 2227)

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sichuan Cancer hospital. ( Site 2218)

    RECRUITING

    Chengdu, Sichuan, 610213, China

  • Taipei Medical University Shuang Ho Hospital ( Site 2612)

    RECRUITING

    New Taipei City, 23561, Taiwan

  • Taizhou Hospital of Zhejiang Province ( Site 2223)

    RECRUITING

    Linhai, Zhejiang, 318000, China

  • The First Affiliated Hospital of Xiamen University. ( Site 2239)

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The Second Xiangya Hospital Of Central South University ( Site 2207)

    RECRUITING

    Changsha, Hunan, 410011, China

  • Tri-Service General Hospital ( Site 2608)

    RECRUITING

    Taipei, 114, Taiwan

  • Ukrainian Center of Tomotherapy ( Site 2014)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)

    RECRUITING

    Wuhan, Hubei, 430048, China

  • University General Hospital of Alexandroupoli ( Site 1206)

    RECRUITING

    Alexandroupoli, East Macedonia and Thrace, 681 00, Greece

  • University Medical Center Groningen ( Site 1505)

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Volyn Regional Clinical Hospital ( Site 2010)

    RECRUITING

    Lutsk, Volyn Oblast, 43018, Ukraine

  • WakeMed Raleigh Campus ( Site 0144)

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)

    RECRUITING

    Xiamen, Fujian, 361000, China

  • Zhongshan Hospital affiliated to Fudan University ( Site 2215)

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

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