Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sierra Oncology LLC - a GSK company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Individuals with KRAS-mutated metastatic or recurrent non-small cell lung cancer
Radiologic documentation of disease progression
Measurable disease per RECIST v1.1
Adequate organ function defined as follows:
* Hepatic: Total conjugated bilirubin ≤ 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x upper limit of normal (ULN) or \< 5 x ULN in the setting of liver metastases
Hematological: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelet ≥ 100 x 10\^9/L, hemoglobin ≥ 9 g/dL
* Renal: Serum creatinine \< 1.5 x ULN OR calculated creatinine clearance (CLcr) ≥ 60 ml/min
Adequate left ventricular ejection fraction (LVEF) ≥ 50%
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Negative serum pregnancy test for females
You may not be if
Less than or equal to 3 weeks since receiving treatment with biologic, small molecule, chemotherapy or other agent for non-small cell lung cancer and 28 days since any prior immunotherapy (such as nivolumab)
History of a concurrent or second malignancy, except for specified exceptions in the protocol or any other cancer that has been in complete remission for ≥ 5 years
Known positive status for human immunodeficiency virus (HIV)
Chronic active or acute viral hepatitis A, B, or C infection or hepatitis B or C carrier
Presence of ≥ Grade 2 peripheral neuropathy
A history of uveitis and/or scleritis
Retinal pathology beyond normal age-related processes
Evidence of a retinal vein occlusion on ophthalmological exam or a history of retinal vein occlusion
History of newly diagnosed or uncontrolled glaucoma/intraocular pressure \> 21 mm Hg as measured by tonography
Use of daily and/or chronic oral or ocular steroids. Individuals must be off daily steroids for at least 3 weeks prior to enrolling into the trial
History of interstitial pneumonitis
History of long QT syndrome or whose corrected QT interval (QTc) measured (Fridericia method) at screening is prolonged (\> 480 ms for males and females)
Clareo Health | Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase
