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Adjuvant calderasib with subcutaneous pembrolizumab plus berahyaluronidase alfa for completely resected KRAS G12C stage IIA–IIIB (N2) NSCLC

A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 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 (KANDLELIT-013)

PHASE3 · Merck Sharp & Dohme LLC · NCT07431827

This trial tests whether adding the oral KRAS G12C inhibitor calderasib to subcutaneous pembrolizumab plus berahyaluronidase alfa helps prevent recurrence in people with completely resected stage IIA–IIIB (N2) KRAS G12C non‑small cell lung cancer.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionspembrolizumab, chemotherapy
Locations24 sites (CABA and 23 other locations)
Trial IDNCT07431827 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind phase 3 trial comparing adjuvant calderasib plus MK-3475A (subcutaneous pembrolizumab and berahyaluronidase alfa) versus placebo plus MK-3475A in participants with completely resected stage IIA–IIIB (N2) KRAS G12C NSCLC. Eligible participants must have no radiographic evidence of disease after surgery and received either neoadjuvant pembrolizumab plus chemotherapy or adjuvant platinum‑doublet chemotherapy, with the first adjuvant dose given within 12 weeks of surgery or last chemotherapy. The primary endpoint is investigator‑assessed disease‑free survival; participants are randomized and treated in a double‑blind fashion to isolate the effect of calderasib. Safety and secondary clinical endpoints will also be collected to compare outcomes between the two arms.

Who should consider this trial

Good fit: People with completely resected stage IIA–IIIB (N2) non‑small cell lung cancer whose tumor harbors a KRAS G12C mutation, who have no evidence of disease on post‑surgical imaging and are within 12 weeks of surgery or last adjuvant chemotherapy, are the intended participants.

Not a fit: Patients without a KRAS G12C mutation, those with residual radiographic disease after surgery, or those more than 12 weeks from their qualifying surgery or adjuvant chemotherapy are not eligible and are unlikely to benefit from this adjuvant approach.

Why it matters

Potential benefit: If successful, adding calderasib may reduce risk of recurrence and extend the time patients remain disease‑free after surgery for KRAS G12C NSCLC.

How similar studies have performed: KRAS G12C inhibitors have shown benefit in advanced/metastatic NSCLC, but using a KRAS G12C inhibitor as adjuvant therapy and combining it with pembrolizumab plus hyaluronidase in this setting is largely novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

CABA and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.