The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Summary

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

Timeline

Start

2005-05

Primary completion

2008-05

Completion

2008-05

Outcome

Missed primary endpoint

Stopped (Enrollment): “slow accrual”

paper median OS was 40.0 weeks in arm A, 32.6 weeks in arm B (p=0.18 vs. A) PMID 18632181 ↗

paper and 39.7 weeks in arm C (p=0.90 vs. A). PMID 18632181 ↗

Publications

• Results Gebbia V, Morena R, Frontini L, Aitini E, Daniele B, Gamucci T, Di Maio M, Morabito A, Gallo C, Gridelli C. The DISTAL-2 phase III randomized trial of single agent weekly docetaxel (wD) vs wD plus gemcitabine (G) or vinorelbine (V) vs wD plus capecitabine (X) as second-line treatment of advanced non-small-cell lung cancer (NSCLC) patients (pts). J Clin Oncol 26: 2008 (May 20 suppl; abstr 19057)
• Results Gebbia V, Gridelli C, Verusio C, Frontini L, Aitini E, Daniele B, Gamucci T, Mancuso G, Di Maio M, Gallo C, Perrone F, Morabito A. Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial. Lung Cancer. 2009 Feb;63(2):251-8. doi: 10.1016/j.lungcan.2008.05.027. Epub 2008 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	625 mg/m2	—
Subject	Docetaxel	Small molecule	30 mg/m2	—
Subject	Docetaxel	Small molecule	33.3 mg/m2	—
Subject	Gemcitabine	Small molecule	800 mg/m2	—
Subject	Vinorelbine	Small molecule	20 mg/m2	—

Indications