Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. Identifier:
First received: April 7, 2010
Last updated: May 7, 2014
Last verified: May 2014

April 7, 2010
May 7, 2014
March 2010
April 2013   (final data collection date for primary outcome measure)
proportion of subjects with progression free survival [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
Estimate the difference between the proportion of subjects with progression free survival who are treated with the combination of CS-7017/Erlotinib or Erlotinib alone.
Same as current
Complete list of historical versions of study NCT01101334 on Archive Site
  • overall survival [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    estimate the overall survival in both treatment groups
  • overall response rate [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    estimate the overall response rate for the two treatment groups
  • plasma concentration of CS-7017 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    determine the plasma concentration of CS-7017 at scheduled time points
  • number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE, and treatment-emergent SAEs. [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
    The number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE) will be summarized by treatment, the worst NCI CTCAE grade, system organ class, and preferred term. Similarly the number and percentage of subjects reporting treatment-emergent SAEs will be summarized.
Same as current
Not Provided
Not Provided
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

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.

Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Non-small Cell Lung Cancer
  • Drug: CS-7017
    CS-7017, Two 0.25mg Tablets administered twice daily
  • Drug: erlotinib
    Erlotinib; One 150mg tablet administered once daily
    Other Name: Tarceva
  • Experimental: CS-7017 plus erlotinib
    • Drug: CS-7017
    • Drug: erlotinib
  • Active Comparator: erlotinib
    Intervention: Drug: erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
  • 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:

  • No treatment with anticancer therapy within 4 weeks before study treatment.
  • No therapeutic or palliative radiation therapy or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
  • No administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
  • No current need for concomitant use of other TZDs during the study.
  • No 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.
  • No 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.
  • No pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
  • Neither pregnant nor breast feeding.
  • No known EGFR mutations.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   India,   Korea, Republic of
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP