Fluzopalil in Combination With Anlotinib for Extensive Small-cell Lung Cancer

NCT04933175 | Unknown Phase 2

• 1 other identifier: LZhenhua
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-Free Survival (PFS)

  From enrollment to 12 month

• Overall Survival (OS)

  From enrollment to 24 month

• Disease control rate(DCR)

  From enrollment to 12 month

Study Arms (1)

fluzopali combined with anlotinib

EXPERIMENTAL

Patients 18 years of age or older, 75 years of age or younger with histologically proven small cell carcinoma of the lung were assessed by radiography as having an extensive stage (according to the American Veteran Lung Cancer Association). Patients received first-line two-drug chemotherapy with standard cisplatin, carboplatin, or lobaplatin, combined with or without immunotherapy, and developed radiologically evaluated disease progression during treatment or within 6 months of completion of treatment.

Drug: Fluzoparil; Drug: Anlotinib

Interventions

Fluzoparil DRUG

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

fluzopali combined with anlotinib

Anlotinib DRUG

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

fluzopali combined with anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteered to participate in the study, signed the informed consent, had good compliance, and cooperated with follow-up;
• Age ≥ 18 years old, ≤ 75 years old, gender is not limited;
• Histological diagnosis of small cell lung cancer, radiographic classification according to the American Legion Lung Cancer Association is extensive stage;
• 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.
• 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;
• The Eastern Cooperative Tumor Group (ECOG) physical status score was 0-2, with a minimum expected survival of 12 weeks;
• 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;
• Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lower limit of normal value (50%);
• 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:

You may not qualify if:

• Subjects will not be enrolled in this study if they meet any of the following criteria:
• Previous primary drug resistance to standard platinum two-drug chemotherapy;
• 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;
• Patients complicated with other malignant tumors, except basal cell carcinoma of the skin and carcinoma in situ;
• Imaging (CT or MRI) showed obvious pulmonary cavitary tumor;
• Participating in other clinical studies or participating in other clinical studies within 4 weeks prior to study commencement;
• Known to be allergic to the study drug ingredients;
• 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;
• Patients with antitumor treatment-related adverse reactions (except alopecia) that did not recover to NCI-CTCAE≤ grade 1 after previous systemic antitumor therapy;
• 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.
• 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.;
• Renal insufficiency: Routine urine indicated that urinary protein was ≥ ++, or confirmed that the 24-hour urinary protein amount was \> 1.0g;
• Patients with unsatisfactory blood pressure control after medication (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg);
• Suffers from serious cardiovascular diseases: Myocardial ischemia or myocardial infarction above Ⅱ, poorly controlled arrhythmia; According to NYHA standard, Ⅲ \~ L cardiac dysfunction, or heart color ultrasound examination indicated left ventricular ejection fraction (LVEF) \< 50%;

Sponsors & Collaborators

• Liu Zhenhua: lead

Study Sites (1)

Liu Zhenhua. ZhuangWu

Fuzhou, Fujain, 350000, China

Location

Related Publications (1)

• Li D, Huang Z, Zhong J, Lin L, Zhang G, Zhuang W, Liu Z. Efficacy and safety of fluzoparib combined with anlotinib in extensive stage small cell lung cancer after first-line platinum-based chemotherapy: a multi-center, single-arm prospective phase II clinical study (STAMP study). BMC Cancer. 2023 Aug 14;23(1):753. doi: 10.1186/s12885-023-11230-5.

  PMID: 37580661 DERIVED

MeSH Terms

Interventions

anlotinib

Study Officials

• Wu Zhuang, Dr.

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenhua Liu, Dr.

CONTACT

13850118018; ahyu1982@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Fluzopali combined with anlotinib for extensive stage small cell lung cancer after failure of first-line platinum-containing chemotherapy

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 21, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)