NCT03516084|TerminatedPhase 3DMC

Study Stopped

As the treatment model of extensive-stage small cell lung cancer changed rapidly and the enrollment speed significantly lower than expected, ZaiLab decided to terminate this study

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

A 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

Zai Lab (Shanghai) Co., Ltd.ClinicalTrials.gov

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1 other identifier

ZL-2306-005

Study Type

interventional

Target

185

Locations

1 country

Sites

Timeline

RegisteredMay 2018

StartedAug 2018

CompletionMar 2020

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

185

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Aug 2018

Geographic Reach

1 country

33 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

April 23, 2018

Completed

11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2020

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed

Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

April 23, 2018

Last Update Submit

December 16, 2020

Conditions

Extensive-stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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.
Approximately 14 months since the first subject enrolled
Overall survival (OS)
The time from randomization to death due to any cause.
Approximately 48 months since first subject enrolled

Secondary Outcomes (1)

Investigator-assessed PFS
Approximately 14 months since the first subject enrolled

Other Outcomes (1)

Change in patient reported outcomes (PROs)--physical functioning domain
Approximately 48 months since first subject enrolled

Study Arms (2)

ZL-2306(nirapairb)

EXPERIMENTAL

Drug: ZL-2306(nirapairb)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ZL-2306(nirapairb)DRUG

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

ZL-2306(nirapairb)

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Zai Lab (Shanghai) Co., Ltd.lead

Study Sites (33)

Anhui Provincal Hospital

Hefei, Anhui, China

Location

Beijing Cancer Hospital