A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Interventions
- Drug: ZL-2306(nirapairb)Drug: Placebo
- Registration Number
- NCT03516084
- Lead Sponsor
- Zai Lab (Shanghai) Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 185
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZL-2306(nirapairb) ZL-2306(nirapairb) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method BICR-assessed progression-free survival (PFS) Approximately 14 months since the first subject enrolled 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) Approximately 48 months since first subject enrolled The time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Investigator-assessed PFS Approximately 14 months since the first subject enrolled 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.
Trial Locations
- Locations (33)
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
Hospital, Academy of Military Medical Sciences
π¨π³Beijing, Beijing, China
Peking union medical college hospital
π¨π³Beijing, Beijing, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Nanjing General Hospital
π¨π³NankΓn, Jiangsu, China
The first affiliated hospital of Guangzhou medical school
π¨π³Guangzhou, Guangdong, China
The first affiliated hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Nantong Tumor Hospital
π¨π³Nantong, Jiangsu, China
Jinzhou Central Hospital
π¨π³Jinzhou, Liaoning, China
Lin Yi Cancer Hospital
π¨π³Linyi, Shandong, China
Tangdu Hospital
π¨π³Xi'an, Shanxi, China
Liaoning Cancer Hospital & Institute
π¨π³Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
π¨π³Shanghai, Shanghai, China
Xinjiang Cancer Hospital
π¨π³ΓrΓΌmqi, Xinjiang, China
First Affiliated Hospital, Zhejiang University
π¨π³Hanzhou, Zhejiang, China
Beijing Chest Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
Fourth Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
Anhui Provincal Hospital
π¨π³Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
π¨π³Beijing, Beijing, China
The second xiangya hospital of central south university
π¨π³Changsha, Hunan, China
Shanghai Chest Hospital, Shanghai Jiao Tong University
π¨π³Shanghai, Shanghai, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
The Second Affiliated hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
Union hospital, Tongji Medical College, Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
The first affiliated hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
Zhejiang cancer hospital
π¨π³Hangzhou, Zhejiang, China
China shenyang chest hospital
π¨π³Shenyang, Liaoning, China
Second Affiliated Hospital, Zhejiang University
π¨π³Hangzhou, Zhejiang, China
Nanfang Hospital
π¨π³Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
π¨π³Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
The First Hospital of Jilin University
π¨π³Changchun, Jilin, China
Fujian Cancer Hospital
π¨π³Fuzhou, Fujian, China