Trial Search Results
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to examine the effects of erlotinib, an FDA-approved medication for the treatment of non-small cell lung cancer compared to a combination therapy of erlotinib and momelotinib (an investigational drug) in humans.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Sierra Oncology, Inc.
Stanford Investigator(s):
Intervention(s):
- Drug: Momelotinib (MMB)
- Drug: Erlotinib
Phase:
Phase 1
Eligibility
Key Inclusion Criteria:
- Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution
mutation
- Treatment naive OR one prior standard chemotherapy that is platinum-based
- Adequate organ function defined as follows:
- Hepatic: Total bilirubin < upper limit of the normal range (ULN); aspartate
transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Hematological: absolute neutrophil count (ANC) ≥1500 cells/mm^3, platelet ≥
100,000 cells/mm^3, hemoglobin ≥ 9.0 g/dL
- Renal: Serum creatinine < ULN OR calculated creatinine clearance (CLcr) of ≥ 60
ml/min
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Key Exclusion Criteria:
- Known positive status for human immunodeficiency virus (HIV)
- Chronic active or acute viral hepatitis A, B, or C infection (testing required for
hepatitis B and C)
- Presence of > Grade 1 peripheral neuropathy
- Symptomatic leptomeningeal, brain metastases, or spinal cord compression.
- History of interstitial pneumonitis
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting