Phase 3 study for people with Lung Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 14 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Merck Sharp & Dohme LLC
Registry number NCT07431827
Started 18 March 2026 Today 16 October 2026 Estimated completion 26 October 2039

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Northern Beaches Hospital ( Site 3009) Frenchs Forest NSW Recruiting
Princess Alexandra Hospital ( Site 3012) Woolloongabba QLD Recruiting
Peninsula University Hospital ( Site 3011) Frankston VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 14 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 400

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 18 March 2026
Estimated completion 26 October 2039
Registry last updated 7 October 2026
Checked by Voxsanity 14 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 October 2026.
  • This page last checked by Voxsanity: 14 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.