A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

Overview

This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer

Full Title of Study: “A Phase Ⅰb/Ⅱ Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 29, 2021

Interventions

  • Drug: Fluzoparib
    • Given PO
  • Drug: temozolomide
    • Given PO
  • Biological: SHR-1316
    • Given injection

Arms, Groups and Cohorts

  • Experimental: Experimental A (part 1) : Fluzoparib + temozolomide
  • Experimental: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

Clinical Trial Outcome Measures

Primary Measures

  • Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
    • Time Frame: At the end of Cycle1 (each cycle is 21 days )
  • Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.
    • Time Frame: Up to approximately 2 Years
  • Phase Ⅱ: Progression Free Survival (PFS) at four months.
    • Time Frame: Up to approximately 2 Years
  • Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
    • Time Frame: Up to approximately 2 Years
    • Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.

Secondary Measures

  • Objective Response Rate
    • Time Frame: up to approximately 2 Years
    • Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
  • Duration of Response
    • Time Frame: Up to approximately 2 Years
    • Duration of Response, determined using RECIST v1.1 criteria.
  • Disease Control Rate
    • Time Frame: Up to approximately 2 Years
    • Disease Control Rate, determined using RECIST v1.1 criteria.
  • Time to Response
    • Time Frame: Up to approximately 2 Years
    • Time to Response, defined as the time from randomization to PR or CR.
  • Overall survival and overall survival at 6 months, 9months and 12 months
    • Time Frame: Up to approximately 1 Year
    • Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.

Participating in This Clinical Trial

Inclusion Criteria

1. Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.

2. Failed one prior line of platinum-based chemotherapy.

3. Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;

4. Freshly acquired samples or archived specimens within 12 months before randomization must be provided.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

6. Participant must have a life expectancy ≥ 12 weeks.

Exclusion Criteria

1. Active or untreated central nervous system (CNS) metastases.

2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

3. History of autoimmune disease.

4. Positive test result for human immunodeficiency virus (HIV).

5. Active hepatitis B or hepatitis C.

6. Severe infections.

7. 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.

8. Significant cardiovascular disease.

9. 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Quanren Wang, PhD, 18036618570, wangquanren@hrglobe.cn

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