Health Condition 1: null- Treatment of patients with advanced non-small cell lung cancer (NSCLC) after failure of a prior chemotherapy regimen.
Conditions
Interventions
Intervention1: CS-7017 (PO, 0.50 mg BID) in combination with erlotinib: (PO, 150 mg once daily)
Control Intervention1: erlotinib alone: (PO, 150 mg once daily)
Sponsors
Daiichi Sankyo Pharma Development
ICON Clinical Research India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: 1.Histologically or cytologically confirmed stage IIIB or IV NSCLC. 2.Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy. 3.Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria. 4.≥ 18 years of age. 5.ECOG performance status of 0, 1, or 2. 6.Adequate organ and bone marrow function as assessed by clinical laboratory evaluations: o Hemoglobin ≥ 9 g/L o Absolute neutrophil count ≥ 1.5 x 109/L o Platelets ≥ 100 x 109/L Serum creatinine 60mL/min o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase o Total bilirubin ≤1.5 x ULN 7.Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade ≤ 1 8.Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter. 9.All female subjects of childbearing potential must have a negative serum or urine pregnancy test result before initiating study treatment. 10.Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC- or IRB-approved ICF (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests. 11.Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1.Treatment with anticancer therapy within 4 weeks before study treatment. 2.Therapeutic or palliative radiation therapy or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases, see Exclusion Criterion No. 4). 3.Prior administration of other TZDs within 4 weeks before study treatment or current need for concomitant use of other TZDs during the study. 4.Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anti convulsants to control associated symptoms; uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Subjects with treated brain metastases which are no longer symptomatic and require no treatment may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 15 days must have elapsed between the end of radiotherapy and study enrollment. 5. 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. 6. 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. 7. 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. 8. History of malignancy other than NCSLC, except adequately treated non melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumors curatively treated with no evidence of disease for ≥ 5 years. 9. Previous administration of CS-7017. 10. Pregnant or breast feeding. 11. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment. 12. Known EGFR mutations. 13. Known hypersensitivity to any of the two study drugs. 14. Subjects currently enrolled in another investigational drug study or within 4 weeks of start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is PFS. Disease progression will be determined in accordance with RECIST criteria, Version 1.1 Timepoint: PFS is defined as the time from the date of randomization until the date of the first objective evidence of disease progression or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are OS, ORR, safety endpoints including AEs, clinical laboratory evaluations, physical examination findings, vital sign measurements, and plasma concentrations of CS-7017. Timepoint: Response data will be obtained from serial radiographic assessments at the end of every 2 cycles (± 7 days) and survival data will be obtained from follow-up communications. Variables based on response to treatment will be assessed in accordance with RECIST criteria, Version 1.1 | — |
Countries
Germany, India, Republic of Korea, United States of America
Contacts
Public ContactMr John Luke
Outcome results
None listed