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

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase Ib Study of SHR-1316 in Combination With Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041011
• Other study ID #: FZPL-Ib-106
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: April 23, 2021

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• 1.Experimental: A (Part 1): Fluzoparib and SHR -1316
1.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
• 2.Experimental: B (Part 1): Fluzoparib and SHR -1316
2.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
• 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion
3.Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).

Locations

Country	Name	City	State
China	Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: 1.Number of Participants with AEs and SAEs		Up to approximately 24 months.
Primary	Part 1: 2. RP2D: Recommended dose for phase II study		Up to approximately 24 months.
Primary	Part 2: 1. ORR: Percentage of Participants With a CR or PR		Up to approximately 24 months.
Secondary	Part 1: 1. ORR: Percentage of Participants With a CR or PR		Up to approximately 24 months.
Secondary	Part 2: 1.Number of Participants with AEs and SAEs		Up to approximately 24 months.
Secondary	Part 2: 2.DoR: Percentage of Participants With a CR or PR		Up to approximately 24 months.
Secondary	Part 2: 3. DCR: Percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.		Up to approximately 24 months.
Secondary	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.		Up to approximately 24 months.
Secondary	Part 2: 5. OS: Baseline until death from any cause		Up to approximately 24 months.