NCT01015443|TerminatedPhase 3ResultsDMC
Loading search results
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
INSPIRE
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
Sponsor study identifier
interventional
285
5 countries
47
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2009
Actual (reported)November 18, 2009
Actual (reported)December 2009
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)June 2015
Actual (reported)August 2, 2016
Actual (reported)Overall Survival (OS) Time
OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.
From the date of randomization until death, assessed up to 5.6 years
Time to Symptom Progression (TTSP)
From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years
Time to Progression (TTP)
From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years
Progression Free Survival (PFS)
From the date of randomization to PD, assessed up to 5.6 years
Time to Treatment Failure (TTF)
From the date of randomization to the date of first missed treatment, assessed up to 5.6 years
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
Saline + Placebo + Best supportive care (BSC)
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.
307 Hospital of Chinese PLA
Beijing, China
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital
Beijing, China
Cancer Institue & Hospital, Chinese Academy of Medical Sciences
Beijing, China
The First Hospital of Jilin University
Changchun, 130021, China
Jillin Provincial Cancer Hospital
Changchun, China
West China Hospital of Sichuan University
Chengdu, Sichuan Province, China
Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.
Wu YL, Park K, Soo RA, Sun Y, Tyroller K, Wages D, Ely G, Yang JC, Mok T. INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer. BMC Cancer. 2011 Oct 7;11:430. doi: 10.1186/1471-2407-11-430.
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
Medical responsible
Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany
285 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2009
First Posted
November 18, 2009
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
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.
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.
A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Southwest Hospital of the Third Military Medical University
Chongqing, China
The Second Affiliate Hospital of the Third Military Medical University
Chongqing, China
Fujian Province Tumor Hospital
Fuzhou, China
Guangdong General Hospital
Guangzhou, China
The First Affilated Hospital of Guangzhou Medical College
Guangzhou, China
Heilongjiang Cancer Hospital
Haerbin, China
China PLA General Hospital
Haidian Districk, Beijing, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Yunan Tumor Hospital
Kunming, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
PLA 81 Hospital
Nanjing, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Fundan University Cancer Hospital
Shanghai, China
Shangahi Pulmonary Hosptial
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Chest Hosptial
Shanghai, China
Cancer Hospital of Shantou University Medical College
Shantou, China
Tongji Hospital of Tongji Medical Colleague of Huazhong University of Science and Technology
Wuhan, China
Peking Union Medical College Hospital
XiCheng District, Beijing, China
Subei People's Hospital
Yangzhou, China
Queen Elizabeth Hospital
Kowloon, Hong Kong
Tuen Mun Hospital
New Territories, Hong Kong
Queen Mary Hospital
Pok Fu Lam, Hong Kong
Prince of Wales Hospital
Shatin, N.T., Hong Kong
National University Hospital
Singapore, Singapore
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsi University College of Medicine
Seoul, South Korea
St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Chang Gung Medical Foundation, Kaohsiung
Kaohsiung County, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Chi Mei Hospital, Liouying
Tainan County, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital, Dept of Chest
Taipei, Taiwan
Chang Gung medical Foundation, Linkou Branch
Taoyuan, Taiwan
Primary Completion
June 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
October 26, 2016
Results First Posted
August 2, 2016
Record last verified: 2016-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: