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

Primary Purpose

Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

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

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

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

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

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

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

Arm Description

Outcomes

Primary Outcome Measures

Part 1: 1.Number of Participants with AEs and SAEs

Part 1: 2. RP2D: Recommended dose for phase II study

Part 2: 1. ORR: Percentage of Participants With a CR or PR

Secondary Outcome Measures

Part 1: 1. ORR: Percentage of Participants With a CR or PR

Part 2: 1.Number of Participants with AEs and SAEs

Part 2: 2.DoR: Percentage of Participants With a CR or PR

Part 2: 3. DCR: Percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

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.

Part 2: 5. OS: Baseline until death from any cause

Full Information

NCT ID

NCT04041011

First Posted

July 31, 2019

Last Updated

June 16, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04041011

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

September 17, 2019 (Actual)

Primary Completion Date

April 23, 2021 (Actual)

Study Completion Date

April 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).

Primary Outcome Measure Information:

Title

Part 1: 1.Number of Participants with AEs and SAEs

Time Frame