A Study of SHR-1316 and Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients

Hengrui Medicine

Status and phase

Completed

Phase 1

Conditions

Small Cell Lung Cancer

Treatments

Drug: 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion

Drug: 2.Experimental: B (Part 1): Fluzoparib and SHR -1316

Drug: 1.Experimental: A (Part 1): Fluzoparib and SHR -1316

Study type

Interventional

Funder types

Industry

Identifiers

NCT04041011

FZPL-Ib-106

Details and patient eligibility

About

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

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be at least 18 years of age.
Histologically or cytologically confirmed SCLC.
Failed at least one prior line of platinum-based chemotherapy.
Patients must have measurable disease as defined by RECIST v1.1.
ECOG 0-1.
Adequate hematologic and organ function
Signed inform consent form

Exclusion criteria

Active or untreated central nervous system (CNS) metastases
Spinal cord compression not definitively treated with surgery and/or radiation .
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Malignancies other than SCLC within 5 years prior to randomization
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
Prior allogeneic bone marrow transplantation or solid organ transplant
Treatment with systemic immunosuppressive medications prior to randomization
Pregnant or lactating women
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.