A randomized phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy for patients with wild-type EGFR non-small cell lung cancer (HOT1002)

Abstract

UMIN000005308.

Anlotinib Combined with S-1 in Third- or Later-Line Stage IV Non-Small Cell Lung Cancer Treatment: A Phase II Clinical Trial

“…Ono et al [ 11 ] reported the use of S‐1 as a third‐ or fourth‐line therapy for NSCLC, with an ORR of 5.7% in a retrospective analysis. A previous study reported [ 12 ] that when S‐1 was used as third‐line therapy, PFS was 3.3 months, and OS was 12.2 months. S‐1 is also well tolerated in elderly patients [ 13 ].…”

Phase II study of S-1 in patients with previously-treated invasive thymoma and thymic carcinoma: North Japan lung cancer study group trial 1203

“…CI, conficence interval. incidence of grade 3/4 pneumonitis has been reported to be similar at 2.8-5.6 % in NSCLC patients after third-line treatment [16][17][18]. We selected a regime of administration for 2 weeks followed by a 1 week rest period in this study based on findings from randomized controlled trials of adjuvant chemotherapy in NSCLC, head and neck cancer and gastric cancer.…”

A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy after standard of chemotherapy for previously treated advanced non-small cell lung cancer

“…Harada et al reported an ORR of 9.8%, median PFS of 3.0 months, and DCR of 61.0% for a single-arm phase II trial of amrubicin monotherapy as third- or fourth-line treatment [26]. On the other hand, a phase II trial of erlotinib vs. S-1 as a third- or fourth-line therapy in patients with advanced NSCLC reported an ORR of 16.7%, DCR of 66.7%, and PFS of 3.3 months for S-1 [27], while a retrospective study reported S-1 ORR and DCR values of 17.0% and 34.4%, respectively, as third-line treatment and 11.3% and 24.5%, respectively, as fourth-line treatment [16].…”