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

Extensive-stage Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03516084
• Other study ID #: ZL-2306-005
• Status: Terminated
• Phase: Phase 3
• Start date: August 20, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: December 2020
• Source: Zai Lab (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 185
• Est. completion date: March 20, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• ZL-2306(nirapairb)
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
• Placebo
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Hospital, Academy of Military Medical Sciences	Beijing	Beijing
China	Peking union medical college hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The second xiangya hospital of central south university	Changsha	Hunan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Nanfang Hospital	Guangzhou	Guangdong
China	The first affiliated hospital of Guangzhou medical school	Guangzhou	Guangdong
China	Second Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang cancer hospital	Hangzhou	Zhejiang
China	First Affiliated Hospital, Zhejiang University	Hanzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincal Hospital	Hefei	Anhui
China	Jinzhou Central Hospital	Jinzhou	Liaoning
China	Lin Yi Cancer Hospital	Linyi	Shandong
China	The first affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing General Hospital	Nankín	Jiangsu
China	The first affiliated hospital of Guangxi Medical University	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai
China	China shenyang chest hospital	Shenyang	Liaoning
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Xinjiang Cancer Hospital	Ürümqi	Xinjiang
China	Union hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zai Lab (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in patient reported outcomes (PROs)--physical functioning domain	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.	Approximately 48 months since first subject enrolled
Primary	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.	Approximately 14 months since the first subject enrolled
Primary	Overall survival (OS)	The time from randomization to death due to any cause.	Approximately 48 months since first subject enrolled
Secondary	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.	Approximately 14 months since the first subject enrolled