The purpose of this study is to evaluate the safety and efficacy of SHR-1316 in combination with Fluzoparib(SHR-3162) in Small Cell Lung Cancer Patients
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
1.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
2.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
3.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Part 1: 1.Number of Participants with AEs and SAEs
Time frame: Up to approximately 24 months.
Part 1: 2. RP2D: Recommended dose for phase II study
Time frame: Up to approximately 24 months.
Part 2: 1. ORR: Percentage of Participants With a CR or PR
Time frame: Up to approximately 24 months.
Part 1: 1. ORR: Percentage of Participants With a CR or PR
Time frame: Up to approximately 24 months.
Part 2: 1.Number of Participants with AEs and SAEs
Time frame: Up to approximately 24 months.
Part 2: 2.DoR: Percentage of Participants With a CR or PR
Time frame: Up to approximately 24 months.
Part 2: 3. DCR: Percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Time frame: Up to approximately 24 months.
Part 2: 4. PFS: PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Up to approximately 24 months.
Part 2: 5. OS: Baseline until death from any cause
Time frame: Up to approximately 24 months.
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