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

NCT03516084 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2020-12-21

No results posted yet for this study

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.

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DRUG

ZL-2306(nirapairb)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zai Lab · Zai Lab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2020-02-21
Completion
2020-03-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516084 on ClinicalTrials.gov