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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516084
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Zai Lab (Shanghai) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Extensive-stage Small Cell Lung Cancer Drug: ZL-2306(nirapairb) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 591 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ZL-2306(nirapairb) Drug: ZL-2306(nirapairb)
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.

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




Primary Outcome Measures :
  1. BICR-assessed progression-free survival (PFS) [ Time Frame: Approximately 14 months since the first subject enrolled ]
    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.

  2. Overall survival (OS) [ Time Frame: Approximately 48 months since first subject enrolled ]
    The time from randomization to death due to any cause.


Secondary Outcome Measures :
  1. Investigator-assessed PFS [ Time Frame: Approximately 14 months since the first subject enrolled ]
    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.


Other Outcome Measures:
  1. Change in patient reported outcomes (PROs)--physical functioning domain [ Time Frame: Approximately 48 months since first subject enrolled ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516084


Contacts
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Contact: Zai Lab +86 21 6163 2588 info@zailaboratory.com

Locations
Show Show 33 study locations
Sponsors and Collaborators
Zai Lab (Shanghai) Co., Ltd.
Investigators
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Study Director: Zai Lab Zai Lab

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Responsible Party: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03516084    
Other Study ID Numbers: ZL-2306-005
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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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
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms