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

Phase 3TerminatedNCT03516084

Zai Lab (Shanghai) Co., Ltd.185 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

185

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

ZL-2306(nirapairb)DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

BICR-assessed progression-free survival (PFS)

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.

Time frame: Approximately 14 months since the first subject enrolled

Overall survival (OS)

The time from randomization to death due to any cause.

Time frame: Approximately 48 months since first subject enrolled

Secondary Outcomes

Investigator-assessed PFS

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.

Time frame: Approximately 14 months since the first subject enrolled

Data from ClinicalTrials.gov

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Anhui Provincal Hospital

Hefei, Anhui, China

Beijing Cancer Hospital