Phase 2 in NSCLC (Study 101)

Phase 2 Trial in Advanced NSCLC – Completed Study

The Phase 1b/2 trial (NCT00630110) evaluated patients with advanced non-small cell lung cancer (NSCLC) to compare the combination of Plinabulin and docetaxel to docetaxel alone.

Study Status


Study Design

Patients with advanced NSCLC previously treated with standard chemotherapy were randomized 1:1 in two dosing cohorts to evaluate a combination of Plinabulin and docetaxel versus docetaxel alone.

  • 30 Cohort: Patients with one prior standard chemotherapy enrolled to evaluate combination therapy of docetaxel plus Plinabulin at 30 mg/m2.
  • 20 Cohort: Patients with one prior standard chemotherapy enrolled to evaluate combination therapy of docetaxel plus Plinabulin at 20 mg/m2.

The experimental arm consisted of combination Docetaxel (75 mg/m2 intravenously) on day 1 plus Plinabulin at RP2D (30 mg/m2 or 20 mg/m2, intravenously) on days one and eight in 21-day cycles while the control arm consisted of Docetaxel alone (75 mg/m2).

The primary endpoint was median overall survival (OS), with secondary endpoints including median progression-free survival (PFS), response rate (RR) and safety. The study also aimed to identify, on an exploratory basis, Plinabulin mechanism-based patient population which responds better to combination therapy of Plinabulin and Docetaxel.

Patients in the sub-analysis were randomized one-to-one in a Plinabulin plus Docetaxel treatment arm compared to docetaxel alone. Patients in the treatment arm received 30 mg/m2 dose of Plinabulin had better anti-cancer efficacy, which was selected as the dose for an ongoing Phase 3 study.

Key Findings

Results of the Phase 2 trial demonstrated that Plinabulin in combination with Docetaxel was well tolerated, with no new or increased toxicity, compared to docetaxel alone.

Anti-cancer efficacy:

Overall, efficacy results appeared better for the combination therapy in the 30 Cohort (Plinabulin 30 mg/m2) compared to the 20 Cohort (Plinabulin 20 mg/m2):

*Data presented at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium

Neutropenia reduction efficacy:

There was a significantly reduced severity and incidence of Neutropenia (low white blood cell count) in patients in the combination Plinabulin and Docetaxel compared to Docetaxel alone.

Plinabulin plus Docetaxel for NSCLC Phase 2 Study -  Safety

Patient Population

Patients with advanced (Stage 3b/4) non-small cell lung cancer (NSCLC) who failed at least one prior platinum-containing (standard) chemotherapy treatment. A total of 172 patients were enrolled in the trial with intent to treat, with 163 patients treated.

More Information

Results of this trial have not yet been published; however, the data were presented at the 50thAmerican Society of Clinical Oncology (ASCO) Annual Meeting in 2014 with sub-analysis results presented at the 16th World Conference on Lung Cancer (WCLC) in 2015.

L. Bazhenova et al., Randomized Phase 2 Study of Plinabulin Combined with Docetaxel in Patientswith Advanced Non-Small Cell Lung Cancer – Mechanism-Based Efficacy Analyses., International Association for the Study of Lung Cancer, Abstract 1505 / P3.01-057, 2015.

R. Suk Heist et al., Randomized phase 2 trial of Plinabulin (NII-2358) plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC). 2014 ASCO Annual Meeting. J Clin. Oncol 32:5s, 2014 (suppl; abstr 8054)