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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04400188
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
20.6
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 11, 2020
Anticipated Primary Completion Date :
Jun 29, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental A (part 1) : Fluzoparib + temozolomide

Drug: Fluzoparib
Given PO

Drug: temozolomide
Given PO
Experimental: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

Drug: Fluzoparib
Given PO

Drug: temozolomide
Given PO

Biological: SHR-1316
Given injection

Outcome Measures

Primary Outcome Measures

  1. Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. [At the end of Cycle1 (each cycle is 21 days )]

  2. Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316. [Up to approximately 2 Years]

  3. Phase Ⅱ: Progression Free Survival (PFS) at four months. [Up to approximately 2 Years]

  4. Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1. [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 Outcome Measures

  1. Objective Response Rate [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.

  2. Duration of Response [Up to approximately 2 Years]

    Duration of Response, determined using RECIST v1.1 criteria.

  3. Disease Control Rate [Up to approximately 2 Years]

    Disease Control Rate, determined using RECIST v1.1 criteria.

  4. Time to Response [Up to approximately 2 Years]

    Time to Response, defined as the time from randomization to PR or CR.

  5. Overall survival and overall survival at 6 months, 9months and 12 months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital of Sichuan University Chengdu Sichuan China 610015

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Study Chair: You Lu, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04400188
Other Study ID Numbers:
  • SHR-3162-Ib-115
First Posted:
May 22, 2020
Last Update Posted:
Jun 22, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Temozolomide

Study Results

No Results Posted as of Jun 22, 2020