Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Condition: Advanced Non-small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: CS-7017; erlotinib
Intervention description: CS-7017, Two 0.25mg Tablets administered twice daily; Erlotinib; One 150mg tablet administered once daily
Intervention MeSH terms: Erlotinib Hydrochloride; Efatutazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC

Summary:

      This is a Phase 2 and open-label (subject will know the treatment he or she is receiving)
      study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

      The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of
      survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed stage IIIB or IV NSCLC.

          -  Recurrent disease (either no response to treatment or subsequent relapse after an
             objective response) that has progressed after first line therapy.

          -  Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
             Version 1.1 criteria.

          -  ≥ 18 years of age.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

          -  Adequate organ and bone marrow function.

          -  Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer
             Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0
             grade ≤ 1.

          -  Agreement to use effective contraception while on treatment and for at least 3 months
             after end of treatment.

        Exclusion Criteria:

          -  Treatment with anticancer therapy within 3 weeks before study treatment.

          -  Therapeutic or palliative radiation therapy within 2 weeks or major surgery within 4
             weeks before study treatment (except for radiotherapy for brain metastases).

          -  Administration of other thiazolidinediones (TZDs) within 4 weeks before study
             treatment.

          -  Current need for concomitant use of other TZDs during the study.

          -  Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known
             human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at
             time of screening.

          -  History of any of the following conditions within 6 months before initiating study
             treatment: diabetes mellitus requiring treatment with insulin or TZD agents;
             myocardial infarction with significant impairment of cardiac function; severe/unstable
             angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association
             (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic
             diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel
             obstruction.

          -  Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement
             with the tumor. Participants with minimal pleural effusion may be eligible upon
             request by Investigator and approval by Sponsor.

          -  Pregnant or breast feeding.

          -  Prior treatment with epidermal growth factor receptor (EGFR) inhibitors.