NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Non-small Cell Lung Cancer

Interventions: Calderasib, MK-3475A, Placebo

Countries: Argentina, Australia, Canada, China, France, Greece, Hong Kong, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (72)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
CABA, Argentina
CABA, Argentina
Frenchs Forest, New South Wales, Australia
Moncton, New Brunswick, Canada
Montreal, Quebec, Canada
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Wuhan, Hubei, China
Changsha, Hunan, China
Shanghai, Shanghai Municipality, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Ningbo, Zhejiang, China
Montpellier, Languedoc-Roussillon, France
Athens, Attica, Greece
Athens, Attica, Greece
Athens, Attica, Greece
Athens, Attica, Greece
Piraeus, Attica, Greece
Thessaloniki, Central Macedonia, Greece
Hong Kong, Hong Kong
Milan, Lombardy, Italy
Goyang-si, Kyonggi-do, South Korea
+ 42 more on CT.gov