Small Cell Lung Cancer
Conditions
Interventions
Intervention group:Fluzoparib combined with temozolomide
Sponsors
Zigong Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with recurrent extensive small cell lung cancer who failed first-line platinum-based chemotherapy. 1.Patients with extensious-stage small cell lung cancer diagnosed by pathology, aged 18 to 75 years, who have failed first-line platinum-based chemotherapy in the past. 2.According to the efficacy evaluation Criteria for Solid Tumors (RECIST Version 1.1), there is at least one radiologically measurable lesion. 3 Eastern Cooperative Oncology Group Performance Status Score (ECOG PS) : 0-1 point. 4Laboratory indicators meet the following standards: (1)Blood routine: Absolute neutrophil count (ANC) >=1.5 × 10^9/L; Hemoglobin >=90g/L Platelet count >=75x10^9/L; (2) Biochemical indicators: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60ml/min; (3)Coagulation function: International normalized Ratio (INR) or prothrombin time (PT) =50%. 6.Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after the cessation of research and treatment, and they must be non-lactating patients. Seven days before the start of administration, the pregnancy test was negative. For men, it is necessary to agree to use appropriate contraceptive methods or have undergone surgical sterilization during the trial and 8 weeks after the last administration of the trial drug. 7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up. 8. Patients with asymptomatic brain metastases or controlled brain metastases (with stable clinical symptoms for at least 2 weeks after symptomatic treatment of brain metastases). In addition, preventive brain irradiation for patients is allowed.
Exclusion criteria
Exclusion criteria: 1. Pathologically confirmed mixed small cell lung cancer and non-small cell lung cancer. 2. Other malignant neoplastic diseases other than small cell lung cancer diagnosed within 5 years before the first administration (excluding radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radical resected carcinoma in situ). 3. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent form. 4. Two weeks (or longer, depending on the defining characteristics of the drug used) before treatment, the last dose of chemotherapy or radiotherapy (except palliative treatment) was received. Patients can receive a stable dose of bisphosphonate for bone metastasis treatment before and during the study, provided that these drugs were initiated at least four weeks before the treatment of flazoparib and temozolomide. 5.Participants who did not discontinue the use of the following categories of CYP3A4 inhibitors could be included if the last CYP3A4 inhibitor had a clearance period of at least 7 days before the initiation of flazoparib and temozolomide treatment. Azole antifungal drugs, macrolide antibiotics, protease inhibitors. 6.There is clinically uncontrollable pleural effusion/peritoneal effusion (subjects who do not require drainage of the effusion or whose effusion does not increase significantly after 3 days of drainage cessation can be enrolled). 7. Before the initiation of treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention measures (i.e., = grade 1 or reaching the baseline, excluding fatigue or alopecia). 8. Have severe cardiovascular diseases, such as New York Heart Association (NYHA) grade 2 or above heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident that occurred within the first 3 months before the first medication. 9. Patients with gastrointestinal diseases who are unable to swallow oral medications and who may interfere with the absorption of the studied drugs. 10. Positive for HBsAg, and the titer of hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood is >=104 copies /ml or >=2000 IU/ml; Or HCV positive; Known history of HIV positivity or known acquired immunodeficiency syndrome. 11.There was a severe infection before the first medication, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. 12. Those who are known to be allergic to the active ingredient or excipients of the drug in this study. 13. It is known that there are mental illnesses, alcohol abuse, inability to quit smoking, drug abuse or drug abuse, etc. 14. The researcher judged that the subjects had other factors that might lead to the forced termination of this study halfway, such as non-compliance with the protocol, other serious diseases (including mental disorders) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that would affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Ratel, DCR;Progression-Free-Survival, PFS; | — |
Countries
China
Contacts
Public ContactJidong Miao
Zigong Fourth People's Hospital
Outcome results
None listed