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New drug combo targets Hard-to-Treat lung cancer mutation

NCT ID NCT07252739

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 8 times

Summary

This study tests a new targeted therapy pill called MK-1084, alone or with other drugs, for people with advanced non-small cell lung cancer that has a specific genetic change called KRAS G12C. The goal is to see if the treatment is safe and can shrink tumors. About 130 participants will be enrolled in this Phase 2 trial.

What this could mean

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

Active substance
MK-1084 (a targeted therapy pill for KRAS G12C mutations) combined with pembrolizumab (Keytruda), cetuximab, carboplatin, or pemetrexed
What this could lead to
If successful, this could provide a new first-line treatment option for people with a specific genetic subtype of lung cancer, potentially shrinking tumors and delaying progression.
What could go wrong
This is an early Phase 2 study with a small number of participants, so results may not apply broadly. The drug combination may cause side effects or fail to improve outcomes compared to existing therapies.

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 140 people

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

Started

Dec 2025

Expected to finish

May 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: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations * Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated * Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement * Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected * Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive * Has undetectable hepatitis C (HCV) viral load if HCV-infected Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease * Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention * Has received prior systemic anticancer therapy for advanced or metastatic NSCLC * Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis * Has received previous treatment with an agent targeting KRAS * Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before allocation/randomization * Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening * 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.

autosomal dominant Parkinson disease 4 cancer neoplasm

As listed by the trial registrant

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

Malignant neoplasm

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

    38 sites in 13 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

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0351)

    RECRUITING

    Bangkok, Bangkok, 10300, Thailand

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0141)

    RECRUITING

    Adana, 1250, Turkey (Türkiye)

  • Bradfordhill ( Site 0168)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)

    RECRUITING

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • Centro de Oncología de Precisión ( Site 0160)

    RECRUITING

    Santiago, Region M. de Santiago, 7560908, Chile

  • Clermont Oncology Center ( Site 0041)

    RECRUITING

    Clermont, Florida, 34711, United States

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)

    RECRUITING

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

  • Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)

    RECRUITING

    Vinnitsya, Vinnytsia Oblast, 21029, Ukraine

  • Deventer Ziekenhuis ( Site 0272)

    RECRUITING

    Deventer, Overijssel, 7416 SE, Netherlands

  • Erciyes University ( Site 0145)

    RECRUITING

    Talas, Kayseri, 38039, Turkey (Türkiye)

  • Evangelismos General Hospital of Athens ( Site 0200)

    RECRUITING

    Athens, Attica, 106 76, Greece

  • Faculty of Medicine Siriraj Hospital ( Site 0350)

    RECRUITING

    Bangkok, Bangkok, 10700, Thailand

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fundacion Arturo Lopez Perez ( Site 0167)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • HYKS Syöpätautien klinikka ( Site 0260)

    RECRUITING

    Helsinki, Uusimaa, 00290, Finland

  • Hacettepe Universite Hastaneleri ( Site 0140)

    RECRUITING

    Ankara, 6230, Turkey (Türkiye)

  • Hong Kong Integrated Oncology Centre ( Site 0232)

    RECRUITING

    Central, 0000, Hong Kong

  • Hong Kong United Oncology Centre ( Site 0231)

    RECRUITING

    Kowloon, Hong Kong

  • Hospital Universitario Virgen de la Macarena ( Site 0093)

    RECRUITING

    Seville, 41009, Spain

  • Koç Üniversitesi Hastanesi ( Site 0142)

    RECRUITING

    Adana, 34010, Turkey (Türkiye)

  • Kuopion Yliopistollinen Sairaala ( Site 0261)

    RECRUITING

    Kuopio, Northern Savonia, 70200, Finland

  • LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)

    RECRUITING

    Kyiv, 03151, Ukraine

  • Leids Universitair Medisch Centrum ( Site 0273)

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)

    RECRUITING

    Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

  • Liv Hospital Ankara ( Site 0146)

    RECRUITING

    Ankara, 06680, Turkey (Türkiye)

  • Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)

    RECRUITING

    Lviv, Lviv Oblast, 79059, Ukraine

  • Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)

    RECRUITING

    Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318)

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Queen Mary Hospital ( Site 0230)

    RECRUITING

    Hong Kong, Hong Kong

  • Sanford Cancer Center Oncology Clinic ( Site 0038)

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Health Roger Maris Cancer Center ( Site 0039)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Severance Hospital Yonsei University Health System ( Site 0080)

    RECRUITING

    Seoul, 03722, South Korea

  • The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306)

    RECRUITING

    Nanchang, Jiangxi, 330209, China

  • Turku University Hospital ( Site 0262)

    RECRUITING

    Turku, Southwest Finland, 20520, Finland

  • Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)

    RECRUITING

    Uzhhorod, Zakarpattia Oblast, 88000, Ukraine

  • VISION PARTNER Medical Centre ( Site 0135)

    ACTIVE_NOT_RECRUITING

    Kyiv, 03022, Ukraine

  • Vaasan Keskussairaala ( Site 0263)

    RECRUITING

    Vaasa, Pohjanmaa, 65130, Finland

  • West China Hospital, Sichuan University ( Site 0315)

    RECRUITING

    Chengdu, Sichuan, 610066, China

  • Zhongshan Hospital Fudan University ( Site 0319)

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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