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

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

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 Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: 1.Experimental: A (Part 1): Fluzoparib and SHR -1316; Drug: 2.Experimental: B (Part 1): Fluzoparib and SHR -1316; Drug: 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1.Experimental: A (Part 1): Fluzoparib and SHR -1316	Drug: 1.Experimental: A (Part 1): Fluzoparib and SHR -1316; 1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
EXPERIMENTAL: 2.Experimental: B (Part 1): Fluzoparib and SHR -1316	Drug: 2.Experimental: B (Part 1): Fluzoparib and SHR -1316; 2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
EXPERIMENTAL: 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion	Drug: 3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion; 3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.
Part 2: 5. OS: Baseline until death from any cause	Up to approximately 24 months.

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2019
• Primary Completion (ACTUAL): April 23, 2021
• Study Completion (ACTUAL): April 23, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: FZPL-Ib-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No