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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT01101334
• Date of registration: 07/04/2010
• Primary sponsor: Daiichi Sankyo Inc.
• Public title: Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
• Scientific title: Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
• Date of first enrolment: March 2010
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01101334
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Germany, India, Korea, Republic of, United States

Key inclusion & exclusion 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Non-small Cell Lung Cancer

Intervention(s)

Drug: CS-7017

Drug: erlotinib

Primary Outcome(s)

proportion of subjects with progression free survival [Time Frame: 4-12 months]

Secondary Outcome(s)

number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE, and treatment-emergent SAEs. [Time Frame: 4-12 months]

overall response rate [Time Frame: 4-12 months]

overall survival [Time Frame: 4-12 months]

plasma concentration of CS-7017 [Time Frame: week 3]

Secondary ID(s)

CS7017-A-U204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors