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

Primary Purpose

Advanced Non-small Cell Lung Cancer (NSCLC)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CS-7017
erlotinib
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer (NSCLC) focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DHHA
  • Gabrail Cancer Center
  • Providence Regional Medical Center Everett
  • Zentrum fur Pneumologie und Thoraxchirurgie
  • King George Hospital
  • Vedanta Institute of Medical Sciences
  • Kodlikeri Memorial Hospital
  • Tata Memorial Hospital
  • Noble Hospital
  • Apollo Speciality Hospital
  • Meenakshi Mission Hospital
  • Orchid Nursing Home
  • St. Vincent's Hospital
  • Hwasun Hospital
  • Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CS-7017 plus erlotinib

erlotinib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 7, 2010
Last Updated
June 12, 2020
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01101334
Brief Title
Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer
Official Title
Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer (NSCLC)
Keywords
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS-7017 plus erlotinib
Arm Type
Experimental
Arm Title
erlotinib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CS-7017
Intervention Description
CS-7017, Two 0.25mg Tablets administered twice daily
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib; One 150mg tablet administered once daily
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to disease progression or death, up to approximately 2.5 years
Secondary Outcome Measure Information:
Title
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
Description
Overall survival (OS) was defined as the time from randomization until death from any cause.
Time Frame
Baseline to death, up to approximately 2.5 years
Title
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Description
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.
Time Frame
Baseline to disease progression or death, up to approximately 2.5 years
Title
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
Description
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.
Time Frame
Baseline to 30 days after last dose, up to approximately 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
DHHA
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Zentrum fur Pneumologie und Thoraxchirurgie
City
Gauting
ZIP/Postal Code
D-82131
Country
Germany
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Vedanta Institute of Medical Sciences
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Kodlikeri Memorial Hospital
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Noble Hospital
City
Pune
State/Province
Maharastra
ZIP/Postal Code
411 013
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 035
Country
India
Facility Name
Meenakshi Mission Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India
Facility Name
Orchid Nursing Home
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 054
Country
India
Facility Name
St. Vincent's Hospital
City
Gyeonggi-Do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Hwasun Hospital
City
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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