NCT07431827

Brief Summary

This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
164mo left

Started Mar 2026

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
3 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Mar 2026Oct 2039

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2039

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

13.6 years

First QC Date

February 19, 2026

Last Update Submit

April 30, 2026

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Disease-free Survival (DFS)

    DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

    Up to ~11 years

Secondary Outcomes (11)

  • Overall Survival (OS)

    Up to ~11 years

  • Distant Metastasis-Free Survival (DMFS)

    Up to ~11 years

  • Lung Cancer Specific Survival (LCSS)

    Up to ~11 years

  • Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    Up to ~11 years

  • Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    Up to ~11 years

  • +6 more secondary outcomes

Study Arms (2)

Calderasib + MK-3475A

EXPERIMENTAL

Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.

Drug: CalderasibBiological: MK-3475A

Placebo + MK-3475A

ACTIVE COMPARATOR

Participants receive placebo qd and MK-3475A q6w for up to 9 doses.

Biological: MK-3475ADrug: Placebo

Interventions

PlaceboDRUG

Placebo oral tablet

Placebo + MK-3475A
MK-3475ABIOLOGICAL

Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.

Also known as: Pembrolizumab (+) Berahyaluronidase alfa
Calderasib + MK-3475APlacebo + MK-3475A
CalderasibDRUG

MK-1084 oral tablet

Also known as: MK-1084
Calderasib + MK-3475A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

National Cancer Center ( Site 3603)

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

RECRUITING

Keimyung University Dongsan Hospital ( Site 3605)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

National Cheng Kung University Hospital ( Site 3706)

Tainan, 704, Taiwan

RECRUITING

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

Cherkasy, Cherkasy Oblast, 18009, Ukraine

RECRUITING

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

Chernivtsi, Chernivetska Oblast, 58013, Ukraine

RECRUITING

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

Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine

RECRUITING

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

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

RECRUITING

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

Kropyvnytskyi, Kirovohrad Oblast, 25006, Ukraine

RECRUITING

Ukrainian Center of Tomotherapy ( Site 1917)

Kropyvnytskyi, Kirovohrad Oblast, 25011, Ukraine

RECRUITING

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

Lviv, Lviv Oblast, 79031, Ukraine

RECRUITING

Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)

Lviv, Lviv Oblast, 79059, Ukraine

RECRUITING

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

Odesa, Odesa Oblast, 65025, Ukraine

RECRUITING

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

Rivne, Rivne Oblast, 33010, Ukraine

RECRUITING

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

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

RECRUITING

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

Lutsk, Volyn Oblast, 43018, Ukraine

RECRUITING

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

Kyiv, 03057, Ukraine

RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 1907)

Kyiv, 03126, Ukraine

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839Trialsites@msd.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

October 26, 2039

Study Completion (Estimated)

October 26, 2039

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

KR(2)UA(14)TW(1)