A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

  • STATUS
    Recruiting
  • End date
    Oct 30, 2024
  • participants needed
    156
  • sponsor
    Shanghai Henlius Biotech
Updated on 13 May 2022

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.

Details
Condition Squamous Non-small-cell Lung Cancer
Treatment HLX10+chemo, HLX10+HLX07+chemo, HLX10+HLX07
Clinical Study IdentifierNCT04976647
SponsorShanghai Henlius Biotech
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Has a life expectancy of greater than 12 weeks
Has adequate organ function

Exclusion Criteria

Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
Has had other active malignancies within 5 years or at the same time
Has uncontrolled pleural effusion、pericardial effusion or ascites
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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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