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

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 Overview

• Status: Terminated
• Conditions: Extensive-stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: ZL-2306(nirapairb); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincal Hospital
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Beijing Cancer Hospital
    • Beijing, Beijing, China
      • Beijing Chest Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Cancer Hospital Chinese Academy of Medical Science
    • Beijing, Beijing, China
      • Hospital, Academy of Military Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian cancer hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The first affiliated hospital of Guangzhou medical school
  • Guangxi
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Henan cancer hospital
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
    • Changsha, Hunan, China
      • The second Xiangya Hospital of Central South University
  • Jiangsu
    • Nankín, Jiangsu, China
      • Nanjing General Hospital
    • Nantong, Jiangsu, China
      • Nantong Tumor Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of NanChang University
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Jinzhou, Liaoning, China
      • Jinzhou Central Hospital
    • Shenyang, Liaoning, China
      • Liaoning cancer Hospital & Institute
    • Shenyang, Liaoning, China
      • China Shenyang Chest Hospital
  • Shandong
    • Linyi, Shandong, China
      • Lin Yi Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital, Shanghai Jiao Tong University
  • Shanxi
    • Xi'an, Shanxi, China
      • Tangdu Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Xinjiang Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, Zhejiang University
    • Hanzhou, Zhejiang, China
      • First affiliated hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
EXPERIMENTAL: ZL-2306(nirapairb)	Drug: ZL-2306(nirapairb); The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported outcomes (PROs)--physical functioning domain	Evaluations of the quality of life of patients with small cell lung cancer include summary and analysis of absolute values and changes from baseline of various fields and single items in the patient-completed EORTC questionnaire QLQ-C30 (Version 3.0) and QLQ-LC13 Chinese version to evaluate the quality of life of lung cancer patients in the treatment group and the control group.	Approximately 48 months since first subject enrolled

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.
• Investigators: Study Director: Zai Lab, Zai Lab

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ACTUAL): February 21, 2020
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (ACTUAL): May 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ZL-2306-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No