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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04400188
• Other study ID #: SHR-3162-Ib-115
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 11, 2020
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 2023
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Fluzoparib
Given PO
• temozolomide
Given PO

Biological:
• SHR-1316
Given injection

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase ?b: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.		At the end of Cycle1 (each cycle is 21 days )
Primary	Phase ?b: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.		Up to approximately 2 Years
Primary	Phase ?: Progression Free Survival (PFS) at four months.		Up to approximately 2 Years
Primary	Phase ?: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.	Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.	Up to approximately 2 Years
Secondary	Objective Response Rate	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.	up to approximately 2 Years
Secondary	Duration of Response	Duration of Response, determined using RECIST v1.1 criteria.	Up to approximately 2 Years
Secondary	Disease Control Rate	Disease Control Rate, determined using RECIST v1.1 criteria.	Up to approximately 2 Years
Secondary	Time to Response	Time to Response, defined as the time from randomization to PR or CR.	Up to approximately 2 Years
Secondary	Overall survival and overall survival at 6 months, 9months and 12 months	Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.	Up to approximately 1 Year