A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

  • STATUS
    Recruiting
  • participants needed
    82
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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Updated on 16 February 2024
See if I qualify
cancer
ct scan
measurable disease
platinum-based chemotherapy
lung cancer
MRI
temozolomide
recurrent small cell lung cancer
fluzoparib
small cell lung cancer

Summary

This research study is a multicentre phase b/ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer

Details
Condition Small Cell Lung Cancer, Small Cell Lung Cancer
Age 18years - 70years
Treatment Temozolomide, Fluzoparib, SHR-1316
Clinical Study IdentifierNCT04400188
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects who have recurrent small cell lung cancer confirmed by histology or cytology
Failed one prior line of platinum-based chemotherapy
Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment)
Freshly acquired samples or archived specimens within 12 months before randomization must be provided
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Participant must have a life expectancy 12 weeks

Exclusion Criteria

Active or untreated central nervous system (CNS) metastases
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
History of autoimmune disease
Positive test result for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
Severe infections
Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment
Significant cardiovascular disease
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
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