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

Study Overview
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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.

Official Title
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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

Conditions
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Extensive-stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: ZL-2306(nirapairb)
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZL-2306(nirapairb)<br> | Drug: ZL-2306(nirapairb)<br>* The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately 14 months since the first subject enrolled |