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CompletedNCT04041011Updated Jun 21, 2022

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

A Phase 1 interventional study of 1.Experimental: A (Part 1): Fluzoparib and SHR -1316 and 2.Experimental: B (Part 1): Fluzoparib and SHR -1316 in Small Cell Lung Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 23 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

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

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

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

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

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

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

Interventions

  • Drug1.Experimental: A (Part 1): Fluzoparib and SHR -1316

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

  • Drug2.Experimental: B (Part 1): Fluzoparib and SHR -1316

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

  • Drug3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion

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

06

What researchers measure

Primary outcomes

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

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

Secondary outcomes

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

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

  5. 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.

    Time frame: Up to approximately 24 months.

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

    Time frame: Up to approximately 24 months.

07

Study locations

1 site
  • Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310005, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04041011
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Aug 1, 2019
Start date
Sep 17, 2019
Primary completion
Apr 23, 2021
Completion
Apr 23, 2021
Last update
Jun 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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