A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Jan 30, 2024
  • participants needed
    120
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 12 June 2021

Summary

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation

Details
Condition Advanced Non Small Cell Lung Cancer
Treatment SHR-A1811
Clinical Study IdentifierNCT04818333
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able and willing to provide a written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy
There is at least one measurable lesion according to RECIST V1.1 criteria

Exclusion Criteria

Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade 1
Has received HER2 antibody drug conjugates
Central nervous system metastasis or meningeal metastasis with clinical symptoms
Has active infection requiring systemic treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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