J Thorac Oncol: Phase 3 clinical trial results of niraparib as the first-line maintenance treatment for platinum-sensitive patients with extensive-stage small cell lung cancer in China

The latest epidemiological analysis shows that lung cancer is the cancer with the second highest age-standardized incidence rate (35.

ZL-2306-005 is a randomized, double-blind, multicenter phase 3 study to evaluate the use of the PARP inhibitor niraparib as a platinum-sensitive extensive-stage small cell lung cancer (ES-SCLC) patient in China The effectiveness and safety of the first-line maintenance treatment.

The study randomly divided patients with standardized, platinum-based, complete/partial remission (CR/PR) after first-line chemotherapy into two groups (2:1) and received niraparib or placebo (300 mg [baseline weight ≥77 kg, platelet count ≥150000/μL] or 200 mg), once a day until the disease progresses or unacceptable toxicity occurs.

Due to changes in the ES-SCLC treatment environment, the ZL-2306-005 trial was terminated early (data cut-off time: March 20, 2020).

Primary endpoint PFS (A) and OS (B)

The median PFS of the niraparib group and the placebo group were 1.

Adverse events

The incidence of adverse events ≥ grade 3 in the niraparib group and placebo group was 34.

In summary, ZL-2306-005 did not reach the main end point.

Ai Xinghao,Pan Yueyin,Shi Jianhua et al.