A Study of SHR-1316 and Fluzoparib（SHR-3162） in Small Cell Lung Cancer Patients
NCT ID: NCT04041011
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2019-09-17
2021-04-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）
NCT04659785
A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)
NCT03083041
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
NCT06430437
A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
NCT04884009
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
NCT04580498
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1.Experimental: A (Part 1): Fluzoparib and SHR -1316
1.Experimental: A (Part 1): Fluzoparib and SHR -1316
1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
2.Experimental: B (Part 1): Fluzoparib and SHR -1316
2.Experimental: B (Part 1): Fluzoparib and SHR -1316
2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion
3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion
3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
1.Experimental: A (Part 1): Fluzoparib and SHR -1316
1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
2.Experimental: B (Part 1): Fluzoparib and SHR -1316
2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion
3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed SCLC.
* Failed at least one prior line of platinum-based chemotherapy.
* Patients must have measurable disease as defined by RECIST v1.1.
* ECOG 0-1.
* Adequate hematologic and organ function
* Signed inform consent form
Exclusion Criteria
* Spinal cord compression not definitively treated with surgery and/or radiation .
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Malignancies other than SCLC within 5 years prior to randomization
* History of autoimmune disease
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infections
* 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.
* Significant cardiovascular disease
* Prior allogeneic bone marrow transplantation or solid organ transplant
* Treatment with systemic immunosuppressive medications prior to randomization
* Pregnant or lactating women
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FZPL-Ib-106
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.