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

Phase 2

Completed

Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: CS-7017
Drug: erlotinib

Registration Number: NCT01101334

Lead Sponsor: Daiichi Sankyo

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-7017 plus erlotinib	CS-7017	-
CS-7017 plus erlotinib	erlotinib	-
erlotinib	erlotinib	-

Primary Outcome Measures

Name	Time	Method
Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to disease progression or death, up to approximately 2.5 years	Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to death, up to approximately 2.5 years	Overall survival (OS) was defined as the time from randomization until death from any cause.
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to disease progression or death, up to approximately 2.5 years	The overall response rate (ORR) was defined as the proportion of participants who achieved best overall response of complete response (CR) or partial response (PR); ORR = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	Baseline to 30 days after last dose, up to approximately 2.5 years	A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state.

Trial Locations

Locations (17): Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Hwasun Hospital
🇰🇷
Jeonnam, Korea, Republic of
Apollo Speciality Hospital
🇮🇳
Chennai, Tamil Nadu, India
Tata Memorial Hospital
🇮🇳
Mumbai, Maharashtra, India
Kodlikeri Memorial Hospital
🇮🇳
Aurangabad, Maharashtra, India
King George Hospital
🇮🇳
Visakhapatnam, Andhra Pradesh, India
Vedanta Institute of Medical Sciences
🇮🇳
Ahmedabad, Gujarat, India
Gabrail Cancer Center
🇺🇸
Canton, Ohio, United States
DHHA
🇺🇸
Denver, Colorado, United States
Zentrum fur Pneumologie und Thoraxchirurgie
🇩🇪
Gauting, Germany
Providence Regional Medical Center Everett
🇺🇸
Everett, Washington, United States
St. Vincent's Hospital
🇰🇷
Gyeonggi-Do, Korea, Republic of
Noble Hospital
🇮🇳
Pune, Maharastra, India
Orchid Nursing Home
🇮🇳
Kolkata, West Bengal, India
Meenakshi Mission Hospital
🇮🇳
Madurai, Tamil Nadu, India
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of