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Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

Phase 2
18 Years
Not Enrolling
Advanced Non-small Cell Lung Cancer

Thank you

Trial Information

Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

proportion of subjects with progression free survival

Outcome Description:

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.

Outcome Time Frame:

4-12 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

April 2013

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Gabrail Cancer Center Canton, Ohio  44718
Providence Regional Medical Center Everett Everett, Washington  98201
DHHA Denver, Colorado  80204