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NCT03516084

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

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2020-03-20

Brief Summary

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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

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Conditions

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Extensive-stage Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZL-2306(nirapairb)

Group Type EXPERIMENTAL

ZL-2306(nirapairb)

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ZL-2306(nirapairb)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zai Lab

Role: STUDY_DIRECTOR

Zai Lab

Locations

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