Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04933175
Other study ID # LZhenhua
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2021
Est. completion date June 2023

Study information

Verified date June 2021
Source Fujian Provincial Hospital
Contact Zhenhua Liu, Dr.
Phone 13850118018
Email ahyu1982@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a the researchers launched a multicenter, prospective, single arm phase II clinical study, the group always had at least two cycle line standard platinum-based treatment and curative effect for SD, at least 6 months during or after the treatment of disease progression broad stage small cell lung cancer patients, evaluating the efficacy and safety of fluzopalil combination With anlotinib. Fifty patients are expected to be enrolled in this study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2023
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - To be included in the study, subjects must meet all of the following inclusion criteria: 1. Volunteered to participate in the study, signed the informed consent, had good compliance, and cooperated with follow-up; 2. Age = 18 years old, = 75 years old, gender is not limited; 3. Histological diagnosis of small cell lung cancer, radiographic classification according to the American Legion Lung Cancer Association is extensive stage; 4. There is at least 1 evaluable lesion according to RECIST1.1, has not received previous local treatment such as irradiation, has not received tissue biopsy during the screening phase, and can be accurately measured at baseline, maximum diameter = 10 mm at baseline (short diameter = 15 mm if lymph node is present). The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion and no prior local treatment such as irradiation, it can be accepted as the target lesion and the baseline evaluation of the tumor lesion should be performed at least 14 days after the diagnostic biopsy. 5. Patients who have received at least 2 cycles of standard platinum-containing chemotherapy (cisplatin, carboplatin or Lobaplatin) with a efficacy of at least SD and who have developed disease progression according to RECIST1.1 as assessed by imaging during treatment or within 6 months after the end of the last treatment; 6. The Eastern Cooperative Tumor Group (ECOG) physical status score was 0-2, with a minimum expected survival of 12 weeks; 7. Peripheral blood and liver and renal function within the following allowable range (detected within 7 days before the start of treatment) : - leukocytes (WBC) =3.0×109/L or neutrophils (ANC) =1.5×109/L; - hemoglobin (HGB) =80 g/L; - platelet (PLT) =80×109/L; - liver transaminase (AST, ALT) < 2.5 times of the upper limit of the normal range; - Total bilirubin (TBIL) < 2 times the upper limit of the normal range; - creatinine (CREAT) < 1.5 times the upper limit of the normal range; 8. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 9. Women of childbearing age should take appropriate contraceptive measures and should not breastfeed for 3 months from screening to the cessation of study treatment. Negative pregnancy test (urine or serum) within 7 days prior to the start of administration, or no risk of pregnancy if one of the following criteria is met: A. Postmenopausal is defined as being older than 50 years of age and amenorrhea for at least 12 months after the cessation of all exogenous hormone replacement therapy; B. Women younger than 50 years of age may be considered postmenopausal if they have had amenorrhea for 12 months or more after discontinuation of all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory postmenopausal reference range; C. Has undergone irreversible sterilization, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, except for bilateral tubal ligation; 10.Men should use barrier contraception (i.e., condoms) for 3 months from screening to discontinuation of study treatment. Exclusion Criteria: - Subjects will not be enrolled in this study if they meet any of the following criteria: 1. Previous primary drug resistance to standard platinum two-drug chemotherapy; 2. Have received any of the following treatments: A. Previous use of any PARP inhibitors or antiangiogenic agents, including anlotinib, bevacizumab, sorafenib; B. Patients who had undergone major surgery within 4 weeks prior to the first dosing of the study drug; C. Have received more than 30% bone marrow irradiation or large area radiotherapy within 4 weeks prior to first dosing of the study drug; 3. Patients complicated with other malignant tumors, except basal cell carcinoma of the skin and carcinoma in situ; 4. Imaging (CT or MRI) showed obvious pulmonary cavitary tumor; 5. Participating in other clinical studies or participating in other clinical studies within 4 weeks prior to study commencement; 6. Known to be allergic to the study drug ingredients; 7. Within 4 weeks before the first dose of test drug treatment has received chemotherapy, radiation therapy, or other test with anticancer therapy (double phosphate except drugs) : always had received a local radiotherapy, if can meet the following conditions into groups: radiation from the end of the treatment to more than 4 weeks (brain radiotherapy for more than 2 weeks). In addition, the target lesions selected in this study were not in the radiotherapy area. Or if the target lesion is within the radiotherapy area but has been confirmed to have progressed; 8. Patients with antitumor treatment-related adverse reactions (except alopecia) that did not recover to NCI-CTCAE= grade 1 after previous systemic antitumor therapy; 9. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 s or APTT >1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Low dose heparin (60 000 ~ 12 000 U per day for adults) or low dose aspirin (100 mg or less per day) are allowed for prophylactic purposes on the premise that INR is =1.5. 10. Clinically significant hemoptysis (more than half tablespoon of hemoptysis per day) occurred within 3 months before enrollment; Or 4 weeks before the group has significant clinical significance of bleeding or bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers (including gastrointestinal perforation and/or fistula, but already after surgical removal of the gastrointestinal tract perforation or fistula, can be allowed into the group), baseline period + + and above of defecate occult blood, healing wounds, ulcers or fracture, etc.; 11. Renal insufficiency: Routine urine indicated that urinary protein was = ++, or confirmed that the 24-hour urinary protein amount was > 1.0g; 12. Patients with unsatisfactory blood pressure control after medication (systolic blood pressure =160 mmHg, diastolic blood pressure =100 mmHg); 13. Suffers from serious cardiovascular diseases: Myocardial ischemia or myocardial infarction above ?, poorly controlled arrhythmia; According to NYHA standard, ? ~ L cardiac dysfunction, or heart color ultrasound examination indicated left ventricular ejection fraction (LVEF) < 50%; 14. Peripheral neuropathy =CTCAE 2 is present, except due to trauma; 15. Uncontrolled medium to large serosal effusions (including pleural effusion, ascites, and pericarpericidal effusion) after pumping treatment, aggravated chronic obstructive pulmonary disease, active pulmonary infection and/or acute bacterial or fungal respiratory disease requiring intravenous antibiotic treatment; 16. Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 17. Artery/venous thrombosis events, such as cerebrovascular accidents (including cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the grouping; 18. A known history of psychotropic substance abuse, alcohol abuse or drug abuse; 19. Uncontrolled active hepatitis after treatment (hepatitis B: HBsAg positive and HBV DNA=1 x 104 copies /ml; Hepatitis C: HCV RNA positive and abnormal liver function); Co-infection with hepatitis B and hepatitis C; 20. Women who are lactating or who have positive blood or urine pregnancy test results within 3 days before the first dosing of study therapy; 21. Patients who, as judged by the Investigator, may have poor compliance with the study procedures and requirements; 22. The investigator identified patients with any condition that jeopardized patient safety or interfered with study evaluation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fluzoparil
Fluzoparil: 150 mg, P.O, BID, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.
Anlotinib
Anlotinib: 8mg, P.O, qd, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.

Locations

Country Name City State
China Liu Zhenhua. ZhuangWu Fuzhou Fujain

Sponsors (1)

Lead Sponsor Collaborator
Liu Zhenhua

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Overall Response Rate (ORR) ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.
The ORR will be reported by percentage with each arms and appropriate confidence intervals.
From randomization to 24 month
Secondary Progression-Free Survival (PFS) PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.
From enrollment to 12 month
Secondary Overall Survival (OS) Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.
The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.
From enrollment to 24 month
Secondary Disease control rate(DCR) DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.
The DCR will be reported by percentage with each arms and appropriate confidence intervals.
From enrollment to 12 month
See also
  Status Clinical Trial Phase
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT01935336 - Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Phase 2
Completed NCT00544596 - R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04063163 - A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Phase 3
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Completed NCT00773955 - R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer Phase 2
Completed NCT00528645 - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer Phase 2
Recruiting NCT05468489 - To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC Phase 2
Active, not recruiting NCT00828139 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer Phase 2
Recruiting NCT05896059 - A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Anlotinib as Maintenance Therapy for ES-SCLC Phase 2
Recruiting NCT04346914 - Study of ZKAB001 Combined With Carboplatin and Etoposide in the Extensive Small Cell Lung Cancer Phase 1
Recruiting NCT06323265 - A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Withdrawn NCT01325753 - Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body N/A
Completed NCT00019006 - Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer Phase 1
Recruiting NCT02972320 - Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic Phase 2
Completed NCT01331525 - The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT01155258 - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors Phase 1
Terminated NCT00088933 - Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer Phase 1
Completed NCT00020202 - FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer Phase 2
Completed NCT02194049 - Cisplatin, Etoposide and PI3K Inhibitor BKM120 in Treating Patients With Advanced Solid Tumors or Small Cell Lung Cancer Phase 1