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:

Gilead Sciences

Intervention(s):

  • Drug: 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