Recruiting
Phase 3

Calderasib & Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07431827

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calderasib

MK-3475A

Placebo

Study Details

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.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT07431827

Start date

Mar 18, 2026

Status verified date

Aug, 2026

Completion date

Oct 26, 2039

Anticipated

Primary completion date

Oct 26, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Calderasib + MK-3475A

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

active comparator: Placebo + MK-3475A

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

Interventions

Calderasib

MK-1084 oral tablet

MK-3475A

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

Placebo

Placebo oral tablet

Primary outcome measure

  • Disease-free Survival (DFS) [ Time Frame: Up to ~11 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Moncton Hospital ( Site 0200)

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

Contacts

Study Coordinator

5068575104

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

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

5148908000x26832

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.