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

Sponsor

Zai Lab (Shanghai) Co., Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03516084

Collaborator

(none)

185

Enrollment

Locations

Arms

Actual Duration (Months)

5.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Extensive-stage Small Cell Lung Cancer	Drug: ZL-2306(nirapairb) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 20, 2018

Actual Primary Completion Date :

Feb 21, 2020

Actual Study Completion Date :

Mar 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ZL-2306(nirapairb)	Drug: ZL-2306(nirapairb) The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
Placebo Comparator: Placebo	Drug: Placebo The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

Arm

Intervention/Treatment

Experimental: ZL-2306(nirapairb)

Drug: ZL-2306(nirapairb)

The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

Placebo Comparator: Placebo

Drug: Placebo

The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Change in patient reported outcomes (PROs)--physical functioning domain [Approximately 48 months since first subject enrolled]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Anhui Provincal Hospital	Hefei	Anhui	China
2	Beijing Cancer Hospital	Beijing	Beijing	China
3	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing	China
4	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing	China
5	Hospital, Academy of Military Medical Sciences	Beijing	Beijing	China
6	Peking union medical college hospital	Beijing	Beijing	China
7	Fujian Cancer Hospital	Fuzhou	Fujian	China
8	Nanfang Hospital	Guangzhou	Guangdong	China
9	The first affiliated hospital of Guangzhou medical school	Guangzhou	Guangdong	China
10	The first affiliated hospital of Guangxi Medical University	Nanning	Guangxi	China
11	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
12	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China
13	Henan Cancer Hospital	Zhengzhou	Henan	China
14	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
15	Union hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China
16	Hunan Cancer Hospital	Changsha	Hunan	China
17	The second xiangya hospital of central south university	Changsha	Hunan	China
18	Nanjing General Hospital	Nankín	Jiangsu	China
19	Nantong Tumor Hospital	Nantong	Jiangsu	China
20	The first affiliated hospital of Nanchang University	Nanchang	Jiangxi	China
21	The Second Affiliated hospital of Nanchang University	Nanchang	Jiangxi	China
22	The First Hospital of Jilin University	Changchun	Jilin	China
23	Jinzhou Central Hospital	Jinzhou	Liaoning	China
24	China shenyang chest hospital	Shenyang	Liaoning	China
25	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning	China
26	Lin Yi Cancer Hospital	Linyi	Shandong	China
27	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China
28	Shanghai Chest Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai	China
29	Tangdu Hospital	Xi'an	Shanxi	China
30	Xinjiang Cancer Hospital	Ürümqi	Xinjiang	China
31	Second Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang	China
32	Zhejiang cancer hospital	Hangzhou	Zhejiang	China
33	First Affiliated Hospital, Zhejiang University	Hanzhou	Zhejiang	China

Sponsors and Collaborators

Zai Lab (Shanghai) Co., Ltd.

Investigators

Study Director: Zai Lab, Zai Lab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zai Lab (Shanghai) Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03516084

Other Study ID Numbers:

ZL-2306-005

First Posted:

May 4, 2018

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Study Results

No Results Posted as of Dec 21, 2020