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Study of DS-1062a in Advanced or Metastatic Non Small Cell Lung Cancer With Actionable Genomic Alterations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04484142
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
This is a study of the safety and efficacy of DS-1062a in subjects with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: DS-1062a Phase 2

Detailed Description:
Eligible participants will be randomized in a 1:1 ratio to 1 of 2 doses of DS-1062a. Randomization will be stratified by NSCLC genomic alteration type. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The investigator and participant will be blinded to the randomized starting dose and to subsequent dose reductions
Primary Purpose: Treatment
Official Title: Phase 2, Multicenter, Randomized Study of DS-1062a in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations and Previously Treated With Kinase Inhibitor Therapy and Platinum Based Chemotherapy With or Without Prior Immunotherapy (TROPION-Lung05)
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DS-1062a 8.0 mg/kg
Participants randomized to starting dose of 8.0 mg/kg of DS-1062a
Drug: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks

Experimental: DS-1062a 6.0 mg/kg
Participants randomized to starting dose of 6.0 mg/kg of DS-1062a
Drug: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks




Primary Outcome Measures :
  1. Objective Response Rate (ORR) As Assessed by Blind Independent Central Review Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
    ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.


Secondary Outcome Measures :
  1. Duration of Response (DOR) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
    DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.

  2. Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous (IV) Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
    PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.

  3. Overall Survival (OS) Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until death due to any cause, up to approximately 23 months ]
    OS is defined as the time from the date of randomization to the date of death due to any cause.

  4. Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Intravenous Infusion in Participants with Advanced or Metastatic NSCLC with Actionable Genomic Alterations [ Time Frame: From baseline up to approximately 23 months post treatment ]
    Reported treatment-emergent adverse events, serious adverse events, adverse events of interest, and those considered related to the study drug or study procedures, or that associated DS-1062a reduction, interruption, or discontinuation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects eligible for inclusion in the study must meet all inclusion criteria for this study.

  • Sign and date the inform consent form (ICF) prior to the start of any study- specific qualification procedures.
  • Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
  • Has pathologically documented NSCLC that:

    1. Is advanced or metastatic.
    2. Has documented positive test results for actionable genomic alterations (i.e, alterations in genes with approved therapies or other driver oncogenes).
  • Has documentation of radiological disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
  • Subject must meet the following prior therapy requirements for advanced or metastatic NSCLC:

    1. Has received at least 1 regimen of a kinase inhibitor, and
    2. At least 1 regimen of platinum-based chemotherapy with or without prior immunotherapy, either in combination or sequentially.
    3. Has had up to 3 prior lines of therapy.
  • Willing and able to undergo a mandatory tumor biopsy
  • Measurable disease based on local imaging assessment using RECIST v1.1 with confirmation based on central imaging review.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.

Exclusion Criteria:

Subjects meeting any exclusion criteria for this study will be excluded from this study.

  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study.
  • Has leptomeningeal carcinomatosis.
  • Uncontrolled or significant cardiovascular disease:

    1. History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
    2. History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
    3. History of New York Heart Association Class 2 to 4 congestive heart failure.
    4. History of serious cardiac arrhythmia requiring treatment.
    5. LVEF <50% or institutional lower limit of normal by ECHO or MUGA scan.
    6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Clinically significant corneal disease.
  • Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484142


Contacts
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Contact: (US sites only) Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Study Director Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT04484142    
Other Study ID Numbers: DS1062-A-U202
2020-002774-27 ( EudraCT Number )
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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
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.
URL: http://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Metastatic Non-small Cell Lung Cancer
Advanced Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
DS-1062a
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms