search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tecemotide
Single low dose cyclophosphamide
Placebo
Saline
Best Supportive Care (BSC)
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Carcinoma, Tecemotide, L-BLP25, Cyclophosphamide, placebo controlled, Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

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:

  • 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

Sites / Locations

  • 307 Hospital of Chinese PLA
  • Beijing Cancer Hospital
  • Beijing Chest Hospital
  • Cancer Institue & Hospital, Chinese Academy of Medical Sciences
  • The First Hospital of Jilin University
  • Jillin Provincial Cancer Hospital
  • West China Hospital of Sichuan University
  • Southwest Hospital of the Third Military Medical University
  • The Second Affiliate Hospital of the Third Military Medical University
  • Fujian Province Tumor Hospital
  • Guangdong General Hospital
  • The First Affilated Hospital of Guangzhou Medical College
  • Heilongjiang Cancer Hospital
  • China PLA General Hospital
  • Sir Run Run Shaw Hospital
  • Zhejiang Cancer Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Yunan Tumor Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jiangsu Cancer Hospital
  • PLA 81 Hospital
  • Fundan University Cancer Hospital
  • Shangahi Pulmonary Hosptial
  • Shanghai Chest Hospital
  • Shanghai Chest Hosptial
  • Cancer Hospital of Shantou University Medical College
  • Tongji Hospital of Tongji Medical Colleague of Huazhong University of Science and Technology
  • Peking Union Medical College Hospital
  • Subei People's Hospital
  • Queen Elizabeth Hospital
  • Tuen Mun Hospital
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Severance Hospital, Yonsi University College of Medicine
  • St. Mary's Hospital, The Catholic University of Korea
  • National University Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Chang Gung Medical Foundation, Kaohsiung
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi Mei Hospital, Liouying
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital, Dept of Chest
  • Chang Gung medical Foundation, Linkou Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational Arm

Control Arm

Arm Description

Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)

Saline + Placebo + Best supportive care (BSC)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Symptom Progression (TTSP)
TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.
Time to Progression (TTP)
Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.
Progression Free Survival (PFS)
Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.
Time to Treatment Failure (TTF)
TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.

Full Information

First Posted
October 1, 2009
Last Updated
September 16, 2016
Sponsor
Merck KGaA, Darmstadt, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01015443
Brief Title
Cancer Vaccine Study for Stage III, Unresectable, Non-small Cell Lung Cancer (NSCLC) in the Asian Population
Acronym
INSPIRE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Carcinoma, Tecemotide, L-BLP25, Cyclophosphamide, placebo controlled, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Arm
Arm Type
Experimental
Arm Description
Tecemotide (L-BLP25) + Single low dose cyclophosphamide + Best supportive care (BSC)
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Saline + Placebo + Best supportive care (BSC)
Intervention Type
Biological
Intervention Name(s)
Tecemotide
Other Intervention Name(s)
L-BLP25, Stimuvax
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Single low dose cyclophosphamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
A single IV infusion of 0.9 percent (%) sodium chloride (saline) will be given 3 days before first placebo vaccination.
Intervention Type
Other
Intervention Name(s)
Best Supportive Care (BSC)
Intervention Description
The BSC will be provided as per the investigator's discretion, and is not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Primary Outcome Measure Information:
Title
Overall Survival (OS) Time
Description
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.
Time Frame
From the date of randomization until death, assessed up to 5.6 years
Secondary Outcome Measure Information:
Title
Time to Symptom Progression (TTSP)
Description
TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.
Time Frame
From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years
Title
Time to Progression (TTP)
Description
Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.
Time Frame
From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years
Title
Progression Free Survival (PFS)
Description
Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.
Time Frame
From the date of randomization to PD, assessed up to 5.6 years
Title
Time to Treatment Failure (TTF)
Description
TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.
Time Frame
From the date of randomization to the date of first missed treatment, assessed up to 5.6 years
Title
Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Description
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Other protocol defined inclusion criteria could apply Exclusion Criteria: 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical responsible
Organizational Affiliation
Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
307 Hospital of Chinese PLA
City
Beijing
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Chest Hospital
City
Beijing
Country
China
Facility Name
Cancer Institue & Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
ChangChun
ZIP/Postal Code
130021
Country
China
Facility Name
Jillin Provincial Cancer Hospital
City
Changchun
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu, Sichuan Province
Country
China
Facility Name
Southwest Hospital of the Third Military Medical University
City
Chongqing
Country
China
Facility Name
The Second Affiliate Hospital of the Third Military Medical University
City
Chongqing
Country
China
Facility Name
Fujian Province Tumor Hospital
City
Fuzhou
Country
China
Facility Name
Guangdong General Hospital
City
GuangZhou
Country
China
Facility Name
The First Affilated Hospital of Guangzhou Medical College
City
Guangzhou
Country
China
Facility Name
Heilongjiang Cancer Hospital
City
Haerbin
Country
China
Facility Name
China PLA General Hospital
City
Haidian Districk, Beijing
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou, Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou, Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Yunan Tumor Hospital
City
Kunming
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing, Jiangsu
Country
China
Facility Name
PLA 81 Hospital
City
Nanjing
Country
China
Facility Name
Fundan University Cancer Hospital
City
Shanghai
Country
China
Facility Name
Shangahi Pulmonary Hosptial
City
Shanghai
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Chest Hosptial
City
Shanghai
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
Country
China
Facility Name
Tongji Hospital of Tongji Medical Colleague of Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Peking Union Medical College Hospital
City
XiCheng District, Beijing
Country
China
Facility Name
Subei People's Hospital
City
Yangzhou
Country
China
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
New Territories
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Pok Fu Lam
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin, N.T.
Country
Hong Kong
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsi University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
St. Mary's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Kaohsiung
City
Kaohsiung County
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung City
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying
City
Tainan County
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital, Dept of Chest
City
Taipei
Country
Taiwan
Facility Name
Chang Gung medical Foundation, Linkou Branch
City
Tao-Yuan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34870327
Citation
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.
Results Reference
derived
PubMed Identifier
21982342
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs