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
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.
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
Wuhan, Hubei, China
Shanghai, Shanghai Municipality, China
Hanzhou, Zhejiang, China