NCT01015443

Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population

A Multi-national, Double-blind, Placebo-controlled, Randomized, Phase III Clinical Trial of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Asian Subjects With Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) Who Have Demonstrated Either Stable Disease or Objective Response Following Primary Chemo-radiotherapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of Asian subjects with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called placebo controlled study).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tecemotide	Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 918 microgram (mcg) of tecemotide (L-BLP25) at Week 1, 2, 3, 4, 5, 6, 7, and 8 (primary treatment phase) and then at 6-Week intervals, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinues for any other reason.
DRUG	Single low dose cyclophosphamide	A single intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first administration of tecemotide.
DRUG	Placebo	Subjects will receive 8 consecutive weekly subcutaneous vaccinations of tecemotide (L-BLP25) matching placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinues for any other reason.
OTHER	Saline	A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
OTHER	Best Supportive Care (BSC)	The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.

Timeline

• Start date: 2009-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2009-11-18
• Last updated: 2016-10-26
• Results posted: 2016-08-02

Locations

47 sites across 5 countries: China, Hong Kong, Singapore, South Korea, Taiwan