lung cancer
Conditions
Interventions
Test group:PD-L1 inhibitor + chemotherapy +PARP inhibitor
Sponsors
Shanxi Bethune Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Participants must have a histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) (according to the U.S. Veterans Lung Cancer Association, VALG Staging). 3. ECOG physical status score is 0-1; 4. ES-SCLC that did not receive any treatment at first visit 5. Expected survival =3 months 6. Patients with no history of symptomatic central nervous system metastasis were eligible to be enrolled if the following conditions were met Only supratentorial and cerebellar metastases are allowed (i.e. no metastases to the midbrain, pons, medulla, or spinal cord); (2) Central nervous system diseases do not require continuous glucocorticoid therapy; No evidence of intracranial progression during screening; 7. The main organ function is normal, that is, it meets the following criteria (without symptomatic treatment within 14 days) : ? Blood routine examination: hemoglobin (Hb) =90g/L; Platelet (PLT) =100×109/L; In the Sexual granulocyte count (ANC) =1.5×109/L; White blood cell count (WBC) =3.0×109/L; Lymphocyte =0.5×109/L; ? Biochemical examination: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =2.5×ULN; In patients with liver metastasis, ALT and AST=5 ULN; Liver or bone metastases: ALP =5 ULN; Serum total bilirubin (TBIL) =1.5×ULN (Gilbert syndrome subjects) = 3×ULN); albumin (ALB) =30 g/L; Renal function: serum creatinine = 1.5 x ULN or creatinine clearance rate (CrCl) = 50mL/minute (using the Cockcroft/Gault formula); ? Coagulation function: Activated partial thromboplastin time (APTT), International Standardized ratio (INR), Prothrombin time (PT) =1.5×ULN; ? Others: Lipase =1.5 x ULN. Lipase >1.5 x ULN is not clinically or radiologically confirmed in the pancreas Adenitis can be included in the group; (5) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)=50% ; 8. Participants with impaired decision-making abilities, provided that their neurological or psychological conditions do not prevent them from participating safely in the study (e.g For example, adverse drug reactions during follow-up) are eligible. 9. Non-surgical sterilized fertile female subjects of reproductive age 72 hours before enrollment in the first drug study Internal serum or urinary HCG tests must be negative and need to be performed during study therapy and 90 years after the end of the study therapy period Use a medically approved form of birth control (such as an IUD, birth control pill or condom) during the day, and must Must be non-lactation period; For men, consent was given during the trial and within 90 days after the last administration of the trial drug Effective method of contraception. 10. Female participants must agree not to breastfeed during the study period or for 180 days after the last dose of study treatment. 11. Participants must agree not to donate blood during the study period or for 90 days after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Participants who progressed from non-small cell lung cancer (NSCLC) to SCLC or SCLC with mixed histology were excluded. 2. The patient has a history of idiopathic pulmonary fibrosis, pneumonia (including drug-induced), tissue pneumonia (e.g., bronchiolitis obliterans, cryptogenic tissue pneumonia, etc.), or evidence of active pneumonia on a chest CT scan. 3. Severe infections such as severe sepsis or septic shock, including but not limited to hospitalization due to complications such as infection, bacteremia or severe pneumonia, occurred within 14 days prior to enrollment Patients with clinical symptoms of central nervous system metastasis (such as brain, spinal cord), pia metastasis; Patients with central nervous symptoms and progression during screening 5. Patients with current symptoms of spinal cord compression that cannot be relieved by drug treatment; 6. An active autoimmune disease requiring systemic treatment (e.g. use of disease-modifying drugs, corticosteroids, or immunosuppressants) or a history of autoimmune disease with expected recurrence has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic. 7. Immunodeficient or study receiving high dose systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to first administration; Physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) are permitted; 8. Have received or plan to receive a prophylactic or live attenuated vaccine within 4 weeks before the first dose; 9. Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF; 10. Subjects with past or co-existing malignant tumors within 5 years require active treatment (with the exception of fully treated patients with expected 5-year survival >90% basal cell or squamous cell skin cancer, cervical carcinoma in situ, local prost adenocarcinoma after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, and breast cancer in situ); 11. Subjects with any severe and/or uncontrolled medical condition, including: a) uncontrolled hypertension (subjects with systolic blood pressure =140 mmHg or diastolic blood pressure =90mmHg; History of hypertensive crisis or hypertensive encephalopathy; b) have clinical symptoms or diseases of the heart that are not well controlled, such as: Had grade 2 myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc =450ms in men, QTc = 470ms in women), grade 2 congestive heart failure (NYHA), unstable angina, had a myocardial infarction within 24 weeks, Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention); c) Cirrhosis, active hepatitis *; * Active hepatitis - Hepatitis B reference: HBsAg positive, exceeding the upper normal value (1000 copy number /ml or 500 IU/ml); Patients with prior hepatitis B virus (HBV) infection or cured of HBV infection (defined as hepatitis B core antibody [HBcAb] present and HbsAg absent, and with normal HBV DNA values detected during the screening period can be included); * Hepatitis C reference: HCV anti-virus positive and HCV virus titer test value exceeds the upper limit of normal /HCV RNA or HCV Ab test indicates acute or chronic infection; d) HIV posit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month Progression-free Survival Rate (PFS-6m%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Objective Response Rate(ORR);Duration of Overall ResponseDoR;Disease Control Rate(DCR);Adverse Events(AE);Progression-free Survival (PFS); | — |
Countries
China
Contacts
Public ContactJunping Zhang
Shanxi Bethune Hospital
Outcome results
None listed