Clinical trial NCT03516084: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Extensive-stage Small Cell Lung Cancer
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: BICR-assessed progression-free survival (PFS)
timeFrame: Approximately 14 months since the first subject enrolled
measure: Overall survival (OS)
timeFrame: Approximately 48 months since first subject enrolled
Secondary outcomes:
measure: Investigator-assessed PFS
timeFrame: Approximately 14 months since the first subject enrolled
Other outcomes:
measure: Change in patient reported outcomes (PROs)--physical functioning domain
timeFrame: Approximately 48 months since first subject enrolled
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Hospital, Academy of Military Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou medical school
state: Guangdong
city: Nanning
country: China
facility: The first affiliated hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Changsha
country: China
facility: The second xiangya hospital of central south university
state: Hunan
city: Nankín
country: China
facility: Nanjing General Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The first affiliated hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: China shenyang chest hospital
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Linyi
country: China
facility: Lin Yi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
city: Ürümqi
country: China
facility: Xinjiang Cancer Hospital
state: Xinjiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
city: Hanzhou
country: China
facility: First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zai Lab
name: Zai Lab
role: STUDY_DIRECTOR
References: