Treatment Rationale and Design for J-AXEL: A Randomized Phase 3 Study Comparing Nab-Paclitaxel With Docetaxel in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer.
Nanoparticle albumin-bound (nab) paclitaxel is a promising new therapeutic agent for all histologic types of non-small-cell lung cancer (NSCLC). We recently performed a phase 2 study of weekly nab-paclitaxel in patients with previously treated advanced NSCLC, finding promising activity and acceptable toxicity for this regimen. We have now designed a randomized phase 3 intergroup study (J-AXEL, UMIN000017487) to examine the clinical benefit and safety of nab-paclitaxel compared to docetaxel in patients with previously treated advanced NSCLC.



Patients are randomized to receive either docetaxel (60 mg/m2on day 1 every 3 weeks, control arm) or nab-paclitaxel (100 mg/m2on days 1, 8, and 15 every 3 weeks, experimental arm), with each drug being administered until disease progression or unacceptable toxicity. The study will evaluate the noninferiority of nab-paclitaxel relative to docetaxel for the primary end point of overall survival.



If the primary objective is achieved, this study will provide evidence for a new alternative treatment option for patients with previously treated advanced NSCLC.
Division of Respiratory Medicine, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yasuto
Y
Yoneshima
Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Satoshi
S
Morita
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
Masahiko
M
Ando
Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Satoru
S
Miura
Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Hiroshige
H
Yoshioka
Department of Respiratory Medicine and Infectious Disease, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Tetsuya
T
Abe
Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Terufumi
T
Kato
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Masashi
M
Kondo
Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Yukio
Y
Hosomi
Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
Katsuyuki
K
Hotta
Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Nobuyuki
N
Yamamoto
Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Junji
J
Kishimoto
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoichi
Y
Nakanishi
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.
Isamu
I
Okamoto
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D012107:Research Design; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult
C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel
Intergroup study; Noninferiority; Overall survival; Previously treated advanced NSCLC; Weekly nab-paclitaxel