Small Cell Lung Cancer
Conditions
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
Interventions
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of Response | Up to approximately 2 Years | Duration of Response, determined using RECIST v1.1 criteria. |
| 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. |
Countries
China
Outcome results
None listed