Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer

The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: CS7017 tablets; Drug: Paclitaxel; Drug: Carboplatin; Drug: Placebo Tablets

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600035
    • Apollo Specialty Hospital
  • Pune, India, 411 001
    • Ruby Hall Clinic
  • Pune, India, 411 013
    • Noble Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560029
      • Kidwai Memorial Institute of Oncology
  • Maharashtra
    • Aundh, Maharashtra, India, 411007
      • Pentagon Research
  • Mumbai Naka
    • Nashik, Mumbai Naka, India, 422005
      • Shatabdi Super Specialty Hospital
  • Navrangpura, Ahmedabad
    • Gujarat, Navrangpura, Ahmedabad, India, 380009
      • Hemato-Oncology Clinic, Vedanta
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625 107
      • Meenakshi Mission Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700054
      • Orchid Nursing Home
• Poland
  • Olsztyn, Poland, 10-228
    • Oddzial Chemioterapii ZOZ MSWiA
  • Poznan, Poland, 60-569
    • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
  • Szczecin, Poland, 70-891
    • Specjalistyczny Szpital im. Prof. Alfresa Sokolowskiego
• Romania
  • Bucuresti, Romania
    • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu
  • Cluj-Napoca, Romania, 400015
    • Institutul Oncologic Prof. Dr. Ion Chiricuta
  • Cluj-Napoca, Romania
    • Institutul Oncologic Prof. Dr. Ion Chiricuta
  • Iasi, Romania
    • Centrul de Oncologie Medicala
  • Judet Timis
    • Timisoara, Judet Timis, Romania, 300239
      • Oncomed SRL
  • Prahova
    • Ploiesti, Prahova, Romania
      • Spitalul Municipal Ploiesti
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University Colorado Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown Univ. Medical Center
  • Illinois
    • Centralia, Illinois, United States, 45042
      • Southern Illinois Hematology/Oncology
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Michiana Hematology-Oncology
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Harbor View Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Ohio
    • Middletown, Ohio, United States, 62801
      • Signal Point Clinical Research Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton Hershey Cancer Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

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 metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
• Age greater than or equal to 18 years
• Adequate organ and bone marrow function

Exclusion Criteria:

• Any prior systemic therapy for NSCLC
• Major surgical procedure or other investigational agents within 4 weeks before study enrollment
• Need for concomitant use of other thiazolidinediones during the study
• History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
• Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CS-7017 with Paclitaxel and Carboplatin	Drug: CS7017 tablets; CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months; Drug: Paclitaxel; Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks; Drug: Carboplatin; IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks
Placebo Comparator: Paclitaxel and Carboplatin	Drug: Paclitaxel; Intravenous (IV), 200 mg/m^2, once every three weeks for up to 18 weeks; Drug: Carboplatin; IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks; Drug: Placebo Tablets; Placebo tablets matching CS-7017 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Progression-Free Survival at 18 Weeks Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. As per Response Evaluation Criteria for Solid Tumors v1.0, disease progression was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started.	18 weeks postdose
Percentage of Participants With Progression-Free Survival Based on Radiologic and Clinical Assessments and Death After Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	Progression-free survival (PFS) was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (based upon radiographic tumor assessments) or death. Disease progression was determined in accordance with the RECIST version 1.0 criteria.	18 weeks postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Kaplan-Meier Analysis of Overall Survival Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	Overall survival (OS) is defined as the time from randomization to the date of death resulting from any cause.	Baseline to date of death, up to approximately 2 years postdose
Number of Participants With Best Overall Tumor Response and Objective Response Rate Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer	As per Response Evaluation Criteria for Solid Tumors v1.0, the best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR.	Baseline to disease progression, death, or withdrawal from study, up to approximately 2 years postdose
Number of Participants With Treatment-Emergent Adverse Events Related to CS-7017/Placebo Following Administration of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-naïve Participants With Metastatic Non-small Cell Lung Cancer		Baseline up to approximately 2 years postdose

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• 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; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Efatutazone
• Other Study ID Numbers: CS7017-A-U202

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