Extensive-stage Small Cell Lung Cancer
Conditions
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.
Interventions
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
DRUGPlacebo
The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BICR-assessed progression-free survival (PFS) | 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) | Approximately 48 months since first subject enrolled | The time from randomization to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed PFS | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported outcomes (PROs)--physical functioning domain | 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. |
Countries
China
Outcome results
None listed