Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population
NCT ID: NCT01015443
Last Updated: 2016-10-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
285 participants
INTERVENTIONAL
2009-12-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Investigational Arm
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
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.
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.
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.
Control Arm
Saline + Placebo + Best supportive care (BSC)
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.
Saline
A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
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.
Interventions
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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.
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.
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.
Saline
A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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:
* Clinically significant hepatic dysfunction
* Clinically significant renal dysfunction
* Clinically significant cardiac disease
* Splenectomy
* Infectious process that in the opinion of the investigator could compromise the subject's ability to mount an immune response
Standard Safety:
* Pregnant or breastfeeding women, women of childbearing potential, unless using effective contraception as determined by the investigator
* Known drug abuse or alcohol abuse
* Participation in another clinical trial (excluding purely observational studies) within the past 28 days
* Requires concurrent treatment with a non-permitted drug
* Known hypersensitivity to any of the trial treatment ingredients
* Legal incapacity or limited legal capacity
* Any other reason that, in the opinion of the investigator precludes the subject from participating in the trial
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical responsible
Role: STUDY_DIRECTOR
Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany
Locations
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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, , 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 City, , 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
Countries
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References
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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.
Other Identifiers
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EMR63325-012
Identifier Type: -
Identifier Source: org_study_id