Phase 3 Trial in Advanced NSCLC (Study 103)

Phase 3 Trial in Advanced NSCLC

Global Pivotal Trial

The global, pivotal Phase 3 trial (NCT02504489) of Plinabulin as a second-line treatment is being conducted in patients with advanced, metastatic non-small cell lung cancer (NSCLC).

16.12.09 phase3 2

Study Status


Study Design

The experimental arm consists of combination Plinabulin (30mg/m2) combined with Docetaxel (75mg/m2), while the control arm will assess Docetaxel alone (75mg/m2).

The planned number of patients for this study is a total of 550 patients, with approximately 110 from the U.S. and western countries and 440 from China. Patients will be stratified on the basis of ECOG performance status, region, and 2nd line or 3rd line who failed PD-1/PD-L1 treatments.

The duration of enrollment is planned for one year, with one year for follow-up after the last patient has been enrolled.

The primary endpoint of the Phase 3 trial is overall survival (OS), with secondary endpoints including progression-free survival (PFS), objective response rate (ORR), duration of response (DOR) safety, severity of neutropenia and granulocyte-colony stimulating factor (G-CSF) use, as well as population pharmacokinetics (PK) in patients enrolled in the U.S., Australia and China.

Patient Population

Patients with advanced non-small cell lung cancer (NSCLC), who have had one prior chemotherapy and have a measurable lung lesion and who are EGFR and ALK wild type.

More Information

For more information on this pivotal trial, please check (NCT02504489).

L. Bazhenova et al., Randomized Phase 3 Trial of Docetaxel + Plinabulin Compared to Docetaxel inAdvanced Non-Small Cell Lung Cancer with at Least 1 Large Lung Lesion., International Association forthe Study of Lung Cancer, Abstract 1498 / P2.01-101, 2015.