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

Phase 1

Active, not recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Fluzoparib; Drug: temozolomide; Biological: SHR-1316

• Registration Number: NCT04400188
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Study Start: 2020-06-11
• Primary Completion: 2022-01-15
• Status Verified: 2022-10
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental A (part 1) : Fluzoparib + temozolomide	temozolomide	-
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316	SHR-1316	-
Experimental A (part 1) : Fluzoparib + temozolomide	Fluzoparib	-
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316	Fluzoparib	-
Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316	temozolomide	-

Primary Outcome Measures

Name	Time	Method
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.
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 )
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
Phase Ⅱ: Progression Free Survival (PFS) at four months.	Up to approximately 2 Years

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	Up to approximately 2 Years	Disease Control Rate, determined using RECIST v1.1 criteria.
Time to Response	Up to approximately 2 Years	Time to Response, defined as the time from randomization to PR or CR.
Duration of Response	Up to approximately 2 Years	Duration of Response, determined using RECIST v1.1 criteria.
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.
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.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China