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A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Primary Purpose

Extensive-stage Small Cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ZL-2306(nirapairb)
Placebo
Sponsored by
Zai Lab (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18-75 years

Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC)

Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Subjects must have adequate bone marrow, renal and hepatic function

Exclusion Criteria:

Subjects with Central Nervous System (CNS) metastases

Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy.

Subjects with pleural effusions that cannot be controlled with appropriate interventions.

All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline

Sites / Locations

  • Anhui Provincal Hospital
  • Beijing Cancer Hospital
  • Beijing Chest Hospital, Capital Medical University
  • Cancer Hospital Chinese Academy of Medical Science
  • Hospital, Academy of Military Medical Sciences
  • Peking union medical college hospital
  • Fujian Cancer Hospital
  • Nanfang Hospital
  • The first affiliated hospital of Guangzhou medical school
  • The first affiliated hospital of Guangxi Medical University
  • Fourth Hospital of Hebei Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Union hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan Cancer Hospital
  • The second xiangya hospital of central south university
  • Nanjing General Hospital
  • Nantong Tumor Hospital
  • The first affiliated hospital of Nanchang University
  • The Second Affiliated hospital of Nanchang University
  • The First Hospital of Jilin University
  • Jinzhou Central Hospital
  • China shenyang chest hospital
  • Liaoning Cancer Hospital & Institute
  • Lin Yi Cancer Hospital
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Chest Hospital, Shanghai Jiao Tong University
  • Tangdu Hospital
  • Xinjiang Cancer Hospital
  • Second Affiliated Hospital, Zhejiang University
  • Zhejiang cancer hospital
  • First Affiliated Hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZL-2306(nirapairb)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

BICR-assessed progression-free survival (PFS)
The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Overall survival (OS)
The time from randomization to death due to any cause.

Secondary Outcome Measures

Investigator-assessed PFS
the investigator-assessed time from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.

Full Information

First Posted
April 23, 2018
Last Updated
December 16, 2020
Sponsor
Zai Lab (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03516084
Brief Title
A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
Official Title
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
February 21, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zai Lab (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZL-2306(nirapairb)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ZL-2306(nirapairb)
Intervention Description
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
Primary Outcome Measure Information:
Title
BICR-assessed progression-free survival (PFS)
Description
The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Time Frame
Approximately 14 months since the first subject enrolled
Title
Overall survival (OS)
Description
The time from randomization to death due to any cause.
Time Frame
Approximately 48 months since first subject enrolled
Secondary Outcome Measure Information:
Title
Investigator-assessed PFS
Description
the investigator-assessed time from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria.
Time Frame
Approximately 14 months since the first subject enrolled
Other Pre-specified Outcome Measures:
Title
Change in patient reported outcomes (PROs)--physical functioning domain
Description
Evaluations of the quality of life of patients with small cell lung cancer include summary and analysis of absolute values and changes from baseline of various fields and single items in the patient-completed EORTC questionnaire QLQ-C30 (Version 3.0) and QLQ-LC13 Chinese version to evaluate the quality of life of lung cancer patients in the treatment group and the control group.
Time Frame
Approximately 48 months since first subject enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-75 years Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST version 1.1) following completion of 4 cycles of first-line platinum-based therapy (cisplatin or carboplatin, plus etoposide) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Subjects must have adequate bone marrow, renal and hepatic function Exclusion Criteria: Subjects with Central Nervous System (CNS) metastases Subjects receiving consolidative chest radiation after last dose of first-line chemotherapy. Subjects with pleural effusions that cannot be controlled with appropriate interventions. All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zai Lab
Organizational Affiliation
Zai Lab
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincal Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Hospital, Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The first affiliated hospital of Guangzhou medical school
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The first affiliated hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Union hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The second xiangya hospital of central south university
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing General Hospital
City
Nankín
State/Province
Jiangsu
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
The first affiliated hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Second Affiliated hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Jinzhou Central Hospital
City
Jinzhou
State/Province
Liaoning
Country
China
Facility Name
China shenyang chest hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Lin Yi Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Chest Hospital, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Xinjiang Cancer Hospital
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Second Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
First Affiliated Hospital, Zhejiang University
City
Hanzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

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