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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

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Zai Lab

Status and phase

Terminated
Phase 3

Conditions

Extensive-stage Small Cell Lung Cancer

Treatments

Drug: ZL-2306(nirapairb)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03516084
ZL-2306-005

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

185 participants in 2 patient groups, including a placebo group

ZL-2306(nirapairb)
Experimental group
Treatment:
Drug: ZL-2306(nirapairb)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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