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.

Study Overview

• Status: Completed
• Conditions: Advanced Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: CS-7017; Drug: erlotinib

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Gauting, Germany, D-82131
    • Zentrum fur Pneumologie und Thoraxchirurgie
• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380009
      • Vedanta Institute Of Medical Sciences
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431001
      • Kodlikeri Memorial Hospital
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial hospital
  • Maharastra
    • Pune, Maharastra, India, 411 013
      • Noble Hospital
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 035
      • Apollo Speciality Hospital
    • Madurai, Tamil Nadu, India, 625107
      • Meenakshi Mission Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700 054
      • Orchid Nursing Home
• Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of, 442-723
    • St. Vincent's Hospital
  • Jeonnam, Korea, Republic of, 519-763
    • Hwasun Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • DHHA
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CS-7017 plus erlotinib	Drug: CS-7017; CS-7017, Two 0.25mg Tablets administered twice daily; Drug: erlotinib; Erlotinib; One 150mg tablet administered once daily; Other Names: Tarceva
Active Comparator: erlotinib	Drug: erlotinib; Erlotinib; One 150mg tablet administered once daily; Other Names: Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline to disease progression or death, up to approximately 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Overall survival (OS) was defined as the time from randomization until death from any cause.	Baseline to death, up to approximately 2.5 years
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy	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.	Baseline to disease progression or death, up to approximately 2.5 years
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	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.	Baseline to 30 days after last dose, up to approximately 2.5 years

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride; Efatutazone
• Other Study ID Numbers: CS7017-A-U204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR