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

Phase 3

Terminated

• 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

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Study Start: 2018-08-20
• Primary Completion: 2020-02-21
• Study Completion: 2020-03-20
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 185

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

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)

Anhui Provincal Hospital; 🇨🇳 Hefei, Anhui, 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

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

The first affiliated hospital of Guangzhou medical school; 🇨🇳 Guangzhou, Guangdong, China

The first affiliated hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

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