Study Stopped
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population
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
1 other identifier
interventional
285
5 countries
47
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Dec 2009
Typical duration for phase_3 nonsmall-cell-lung-cancer
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
August 2, 2016
CompletedOctober 26, 2016
September 1, 2016
5.5 years
October 1, 2009
June 17, 2016
September 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
Study Arms (2)
Investigational Arm
EXPERIMENTALTecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
Control Arm
PLACEBO COMPARATORSaline + Placebo + Best supportive care (BSC)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented unresectable stage III non-small cell lung cancer (NSCLC)
- Documented stable disease or objective response, according to Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST v1.0) after primary concomitant chemo-radiotherapy for unresectable stage III disease, within four weeks (28 days) prior to randomization
- Receipt of concomitant chemo-radiotherapy. The chemotherapy-part must have been platinum-based, must have been administered with a minimum of two cycles overlap with radiotherapy (one cycle lasts either 3 or 4 weeks depending on the chemotherapy regimen), and a minimum of two platinum-based chemotherapy administrations must have been given during radiotherapy. Purely radio sensitizing doses of chemotherapy are not acceptable. Radiotherapy must have delivered a radiation dose of \>= (greater than or equal to) 50 Gray (Gy). Induction or consolidation chemotherapy is allowed and if given, should be accounted as part of primary thoracic chemoradiotherapy. Subjects must have completed the primary thoracic chemo-radiotherapy at least four weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary chemo-radiotherapy are eligible
- Geographically accessible for ongoing follow-up, and committed to comply with the designated visits
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A platelet count \>= the lower limit of normal for the site or \>= 100 x 10\^9 per liter (/Liter) (whichever is greater); white blood cell (WBC) \>= 2.5 x 10\^9/Liter and haemoglobin \>= 90 gram per liter (g/L)
- \>=18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is greater than \[\>\] 18 years of age)
You may not qualify if:
- Pre-Therapies\*:
- Prior sequential chemo-radiotherapy
- Lung-cancer-specific therapy (including surgery) other than primary chemoradiotherapy
- Immunotherapy (e.g., interferons, tumor necrosis factor \[TNF\], interleukins, or biological response modifiers \[granulocyte macrophage colony stimulating factor {GMCSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}\], monoclonal antibodies) within four weeks (28 days) prior to randomization
- Investigational systemic drugs (including off-label use of approved products) within four weeks (28 days) prior to randomization
- Disease Status:
- Metastatic disease
- Malignant pleural effusion at initial diagnosis and/or at trial entry
- Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years
- Autoimmune disease
- A recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
- Any preexisting medical condition requiring chronic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
- Known active Hepatitis B infection and/or Hepatitis C infection
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or of family members who suffer(ed) from such
- Physiological Functions:
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
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
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 District, Taiwan
Related Publications (2)
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.
PMID: 34870327DERIVEDWu 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.
PMID: 21982342DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical responsible
Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
November 18, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 26, 2016
Results First Posted
August 2, 2016
Record last verified: 2016-09