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

NCT04041011 | Completed Phase 1

• 1 other identifier: FZPL-Ib-106
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

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

  Up to approximately 24 months.

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

  Up to approximately 24 months.

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

  Up to approximately 24 months.

Secondary Outcomes (6)

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

  Up to approximately 24 months.

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

  Up to approximately 24 months.

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

  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.

  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.

  Up to approximately 24 months.

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

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

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

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310005, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 1, 2019
• Study Start: September 17, 2019
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)