Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutated non‑small cell lung cancer after chemoradiotherapy

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What is this study about?

The trial focuses on people with locally advanced, unresectable stage II‑III non‑small cell lung cancer that carries a KRAS G12C genetic change. After completing standard platinum‑based chemoradiotherapy, participants receive either an oral tablet called MK‑1084 together with an intravenous infusion of durvalumab, or the same infusion with a matching placebo tablet.

The aim is to determine whether the drug combination can keep the cancer from growing for a longer time compared with the infusion alone. Participants are randomly assigned to one of the two groups, and the study is double‑blind, meaning neither the participants nor the study staff know which tablet is being taken.

During the study, participants attend regular clinic visits where the infusion is given, the oral tablet is taken daily, and health checks are performed. Blood tests, imaging scans, and questionnaires about quality of life are used to track safety and any side effects. Treatment continues until the cancer shows signs of progression, an unacceptable side effect occurs, or the study ends.

1 enrollment and consent

after joining the study, you will sign a consent form that explains the purpose of the trial and the procedures involved.

the study staff will collect basic health information, including your medical history and current medications.

2 baseline assessments

a series of tests will be performed to establish your starting condition. these may include blood tests, imaging scans, and questionnaires about quality of life.

the results will be used to compare future changes during the trial.

3 randomization

you will be assigned, by a computer system, to receive either mk-1084 plus durvalumab or placebo plus durvalumab. the assignment is double‑blind, meaning neither you nor the study staff will know which oral product you receive.

4 start oral medication

you will begin taking a film‑coated tablet once daily. the tablet contains either mk-1084 or a matching placebo.

the dose listed for mk-1084 is 0 % (v/v), which reflects the formulation used in the study; you will follow the dosing schedule provided by the study pharmacy.

5 first durvalumab infusion

you will receive an intravenous (iv) infusion of durvalumab at a dose of 1500 mg. the infusion is administered through a needle placed in a vein and takes several hours to complete.

the exact timing of subsequent infusions follows the study protocol, which may be every few weeks, but the schedule will be explained to you by the study team.

6 ongoing treatment and monitoring

you will continue the daily oral tablet (mk-1084 or placebo) as instructed.

additional durvalumab infusions will be given according to the protocol schedule.

regular visits will be scheduled for safety checks, blood tests, imaging scans, and quality‑of‑life questionnaires to assess how the treatment is working and to monitor any side effects.

7 treatment continuation or discontinuation

treatment will continue until disease progression is observed, an unacceptable adverse event occurs, or the study reaches its planned end.

if treatment is stopped, you will still be followed for a period of time to collect final outcome data.

Who Can Join the Study?

Has a histological or cytological diagnosis (a diagnosis made by examining tissue or cells) of locally advanced, unresected Stage II (node‑positive) to Stage III non‑small cell lung cancer (NSCLC) that is mainly nonsquamous (not the squamous cell type).
Has finished a full course of platinum‑based concurrent chemoradiotherapy (CCRT) (chemotherapy with platinum drugs given at the same time as radiation) before joining the study, and the cancer has not shown disease progression (has not gotten larger or spread).
Has provided a tumor tissue sample for a central laboratory to test for KRAS G12C mutation (a specific genetic change), PD‑L1 status (a protein that can affect the immune system), and other biomarker research.
The tumor sample shows a confirmed presence of the KRAS G12C mutation and an evaluable PD‑L1 status result.
If you are infected with human immunodeficiency virus (HIV), the virus must be well‑controlled with antiretroviral therapy (ART) (medicines that keep the virus low).
If you test positive for hepatitis B surface antigen (HBsAg), you must have an undetectable hepatitis B virus (HBV) viral load (no measurable virus in the blood) and be receiving HBV antiviral therapy (medicine that treats hepatitis B).
If you have a history of hepatitis C virus (HCV) infection, the HCV viral load must be undetectable (no measurable virus in the blood).
Your body weight must be at least 35 kg (about 77 pounds).

Who Cannot Join the Study?

Having a diagnosis of small cell lung cancer (a different type of lung cancer) or a tumor that contains small cell elements.
Having an active infection that needs systemic therapy (medication that works throughout the whole body).
Having a past history of a stem cell or solid organ transplant (receiving new bone marrow or an organ such as a kidney or liver).
Not having fully recovered from a major surgery (a big operation) or still having problems from that surgery.
Having a stomach or intestinal problem that interferes with how medicines are absorbed, or being unable to swallow pills taken by mouth.
Having active inflammatory bowel disease (conditions like Crohn’s disease or ulcerative colitis) that requires immunosuppressive medication (drugs that lower the immune system), or a clear past history of such disease.
Having uncontrolled, serious cardiovascular disease (heart or blood‑vessel problems) or cerebrovascular disease (blood‑vessel problems in the brain).
Being infected with HIV and having a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (rare cancers that can occur with weakened immunity).
Having received any prior treatment for non‑small cell lung cancer (NSCLC) other than definitive CCRT (combined chemotherapy and radiation given as a cure).
Having another cancer that is getting worse or that needed active treatment within the past three years.
Having an active autoimmune disease (where the body attacks itself) that required systemic treatment (medicine that works throughout the body) in the past two years.
Having a past or current non‑infectious pneumonitis or interstitial lung disease (inflammation of lung tissue) that required or now requires steroids (anti‑inflammatory medicines).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Metaxa Cancer Center Hospital Of Piraeus	Piraeus	Greece
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Centre Francois Baclesse	Caen	France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Alexandra Hospital	Athens	Greece
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Hopital Ambroise Pare	Boulogne-Billancourt	France
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Hopital Prive Clairval	Marseille	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Katholisches Marienkrankenhaus gGmbH	Hamburg	Germany
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Ziekenhuisgroep Twente Stichting	Almelo	The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Lmvmi Gadwrrd Hkyfsxzp On Acyiga	Athens	Greece
Apyuw Hicvkxefoubl Nfjb Apwmnl Cduhtyas	Valenciennes	France
Ijzjtlvz Rvrcfrxrx Prt Lf Svttae Dhr Tnchpd Dfmw Aahnlem Iudt Sqzqlw	Meldola	Italy
Cfux Dd Napxb	Vandoeuvre Les Nancy	France
Anqwfb Mdribls Cigttn Sddj	Thessaloniki	Greece
Nuhvgbal Igysaeic Oqjbbtokb Imf Mfnpe Skjowdrxkhsndhffbldavnjgyxxh Iapsjwty Bpsvhymp	Cracow	Poland
Utklriynqb Mwrhsqt Cabndc Hbocjsaupkqmbvksy	Hamburg	Germany
Udbbpbcbfbuvjaclciqlw Euufd Ach	Essen	Germany
Igjeqe Iomebkkn Foukkyomkkoxg Oqmaligqadh	Rome	Italy
Lbqar Ujofnmuofbxe Mgbotpl Cyaygnf (jdbiz	Leiden	The Netherlands
Ubcqdyrjyxna Myujwyp Cxejyyu Giawxchio	Groningen	The Netherlands
Wfkxtqzdbi Surowiw Iud Sucxfpz Pyz W Pdjkohgwb	Przemysl	Poland
Ketsqmfay Sbaodwj Srialdivtcwwoys ip Jtmt Pkcre Iv	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	07.07.2026
Germany	Not yet recruiting	07.07.2026
Greece	Not yet recruiting	07.07.2026
Italy	Not yet recruiting	07.07.2026
Poland	Not yet recruiting	07.07.2026
The Netherlands	Recruiting	07.07.2026

Trial locations

Investigated drugs:

MK-1084 is an experimental oral tablet that participants take by mouth. In this study the drug is being tested to see if it can improve the effect of an existing cancer‑fighting therapy. Researchers want to know whether adding MK‑1084 helps slow the growth of lung cancer compared with not using it.

Durvalumab is a medicine given through an IV infusion. It belongs to a class of treatments called immunotherapy, which work by helping the body’s immune system recognize and attack cancer cells. In the trial, every participant receives durvalumab, and the researchers compare outcomes when it is used together with MK‑1084 versus when it is used with a placebo.

Investigated diseases:

Non-small cell lung cancer

Non‑small cell lung cancer, KRAS G12C‑mutated, locally advanced, unresectable (Stage II‑III) – This cancer starts in the lining of the airways and carries a specific KRAS gene change. In the locally advanced stage, the tumor has grown beyond its original location but has not spread to distant parts of the body. Because of its size or position, it cannot be removed by surgery. The disease may slowly enlarge and involve nearby lymph nodes or tissues. Over time, the tumor can cause symptoms such as coughing, breathlessness, or chest discomfort.

Trial ID:

2025-522038-29-00

Protocol code:

MK-1084-015

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutated non‑small cell lung cancer after chemoradiotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?