Although nab-PTX plus carboplatin is one of the standard treatment for chemo-naive advanced non-small cell lung cancer (NSCLC), the efficacy, safety and optimal schedule of nab-PTX monotherapy as 2nd or 3rd line for NSCLC pts without any driver mutations remains unknown.
This was a single arm phase I/II study. Eligible pts are advanced NSCLC without EGFR mutation and ALK rearrangement that progressed after platinum-doublet chemotherapy. The pts were received 100 mg/m2 of nab-PTX on day 1, 8, 15 and 22 (level 0) or on day 1, 8, and 15 (level -1) every 4-week in phase I. Dose limiting toxicities (DLT) were assessed and the recommended schedule was determined in the phase I. The primary endpoint was objective response rate (ORR), assuming that estimated ORR was 15% and threshold ORR was 5% with α error of 0.05 and β error of 0.2 in the phase II part. Total 55 pts were planned to be enrolled.
The recommended schedule of nab-PTX was determined as the level -1, because the DLTs were found in 4 of 5 pts in level 0. Total 55 pts were enrolled in the phase II and the characteristics were as followings; median age, 66 years (range, 41–90 years), male/female = 40/15, PS 0/1/2 = 12/39/4, 2nd/3rd line = 34/21, adeno/squamous/large/others = 34/17/2/2. The median number of treatment cycles was three (range, 1–10). The ORR was 7.3% (95% [CI], 2.0 – 17.6%) (PR (n = 4), SD (n = 26), PD (n = 24), and NE (n = 1)). At the median follow-up time of 5.3 months (range, 1.9 – 26.0 months) for all pts, the median PFS was 3.4 months (95%[CI], 1.9 – 4.0 months). Treatment related grade 3 or 4 toxicities were neutropenia (36%), pulmonary infection (3.6%), and pneumonitis (5.4%). One patient (2%) was died due to treatment-related ARDS.
In phase I part, we confirmed that schedule level -1 was tolerable and the schedule had been recommended. In phase II part, this study failed to meet predefined primary endpoint although PFS was comparable and toxicity was acceptable for pts with advanced NSCLC without any driver mutations as 2nd or 3rd line treatment.
Clinical trial identification
Legal entity responsible for the study
Okayama Lung Cancer Study Group
All authors have declared no conflicts of interest.