A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）

NCT04659785 | Unknown Phase 1

• 1 other identifier: ES-SCLC-2nd-IIT-SHR3162-APA
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

Fluzoparib; Apatinib; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability and efficacy data collected during the dose escalation portion of the study

  Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy

• PhaseⅠb: Incidence of Adverse Events [safety and tolerability]

  Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0

  From screening up to 28 days after end of treatment

• Phase Ⅱ: Objective Response Rate(ORR) as Assessed by the Investigator according to RECIST v1.1

  Objective Response Rate(Complete response + Partial response (CR+PR)), determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.

  up to approximately 2 Years

Secondary Outcomes (5)

• Progression Free Survival（PFS）

  Up to approximately 2 Years

• Overall survival（OS）

  Up to approximately 2 Years

• Duration of Response（DoR）

  Up to approximately 2 Years

• Adverse Event Rate（AER）

  Up to approximately 2 Years

• Biomarker Detection

  Up to approximately 2 Years

Study Arms (1)

Fluzoparib + Apatinib

EXPERIMENTAL

Fluzoparib and apatinib will be administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.

Drug: Fluzoparib; Drug: Apatinib

Interventions

Fluzoparib DRUG

Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity

Also known as: SHR3162, HS10160

Fluzoparib + Apatinib

Apatinib DRUG

Take apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity

Also known as: Apatinib mesylate

Fluzoparib + Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Extensive Stage Small Cell Lung Cancer diagnosed by pathology (histology or cytology) (according to WHO classification in 2015);
• Failure of first-line treatment；
• Age 18-70 years old;
• ≤21 days before the first study drug, CT or MRI scan, at least one target lesion without previous radiotherapy as defined by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1);
• PS score: 0-2; the expected survival time ≥ 12 weeks;
• No anti-angiogenesis drugs or PARP inhibitors have been used in previous treatments;

You may not qualify if:

• No blood transfusion or blood products, no correction with G-CSF and other hematopoietic stimulating factors within 14 days before the first administration. First research before investigating drugs, laboratory test values meet the following conditions:
• Blood routine: white blood cell count (WBC) ≥3.0 × 109/L; absolute neutrophil count (ANC) ≥1.5 × 109/L; Platelet (PLT) ≥100 × 109/L; Hemoglobin content (HGB) ≥9.0 g/dL;
• Liver function: Aspartate aminotransferase (AST) ≤2.5 x ULN in subjects without liver metastasis, alanine liver aminotransferase (ALT) ≤2.5 x ULN; ALT and AST in subjects with liver metastases \<5 x ULN; Serum total bilirubin (TBIL) ≤1.5 x ULN (except Gilbert syndrome total bilirubin \<3.0 mg/dL); Albumin (ALB) ≥3 g/dL;
• Renal function: serum creatinine ≤1.5 x ULN or creatinine clearance CrCl≥40 mL/minute;
• Coagulation function: International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
• Others: Lipase ≤ 1.5 x ULN, if lipase\> 1.5 x ULN but no clinical or imaging confirmed pancreatitis can be included; amylase ≤ 1.5 x ULN, if amylase\> 1.5 x ULN but no clinical or imaging confirmed pancreatitis can be included in the group. Alkaline phosphatase (ALP)≤2.5ULN, subjects with bone metastases, ALP≤5ULN;
• Non-surgically sterilized female subjects of childbearing age must have a negative serum HCG test within 3 days before the first medication, and non-lactating period. Male subjects and females of childbearing age must start the first study drug to after the last study drug 6 contraception within months;
• Subjects voluntarily join the study, with good compliance, with safety and survival follow-up.
• Active brain metastases or meningeal metastases with clinical symptoms. Subjects with treated brain metastases need to meet the following conditions to be tested considered into the group:
• It is confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) that the lesion is stable since the end of treatment≥4 weeks;
• No need to receive systemic corticosteroids (\>10mg/day prednisone or equivalent dose) treatment;
• The third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion and effusion that cannot be controlled by pumping or other treatments ascites;
• People with symptoms of cough, hemoptysis, bloody sputum within 1 month before the first medication;
• Minor surgery (including catheterization) was performed within 48 hours before the first study drug;
• Other anti-tumor drugs are currently being used within 4 weeks after the last systemic cytotoxic drug treatment or radiotherapy drug treatment;

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead

Study Sites (1)

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

fluzoparib; apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haitao Wang

  Tianjin Medical University Second Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haitao Wang, MD

CONTACT

+86-022-88326791; peterrock2000@126.com

Li Zang, MD

CONTACT

+86-15202259910; 15202259910@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: July 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2022
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

CN (1)