A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT03516084 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2018
Last Update Posted : January 24, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Extensive-stage Small Cell Lung Cancer | Drug: ZL-2306(nirapairb) Drug: Placebo | Phase 3 |
| 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 |
| 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. |
- 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.
- Overall survival (OS) [ Time Frame: Approximately 48 months since first subject enrolled ]The time from randomization to death due to any cause.
- 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.
- 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.
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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 |
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
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
| Contact: Zai Lab | +86 21 6163 2588 | info@zailaboratory.com |
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| Study Director: | Zai Lab | Zai Lab |
| 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 |
| 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 |
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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 |