For Healthcare Professionals

U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

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About the study

This study is designed to evaluate safety and antitumor activity of U3-1402 in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

for both Dose Escalation and Dose Expansion:

  1. Has locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation
  2. Has at least one measurable lesion per RECIST version 1.1
  3. Has Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening

EXCLUSION CRITERIA

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall +81-3-6225-1111 (M-F 9-5 JST)Email iconEmail Study Center

    Study’s details


    Contition

    Non-Small Cell Lung Cancer (NSCLC)

    Age

    18+

    Phase

    Phase 1

    Participants needed

    264

    Est. Completion Date

    Dec 2023

    Treatment type

    Interventional


    Sponsor

    Daiichi Sankyo, Inc.

    ClinicalTrials.gov identifier

    NCT03260491

    Study number

    U31402-A-U102

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