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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Merck KGaA
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01015443
First received: October 1, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 patients with unresectable stage III non-small cell lung cancer in comparison to a placebo plus best supportive care (a so-called Placebo controlled study).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Biological: Tecemotide (L-BLP25)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Overall Survival Time [ Time Frame: Time from randomization to death or last date known to be alive, reported between day of first patient randomised, Dec 2009, until cut-off date expected May 2020 ] [ Designated as safety issue: No ]
    Time from randomization to death. Patients without event are censored at the date of last contact, or date lost to follow-up


Secondary Outcome Measures:
  • Safety - Adverse Events [ Time Frame: Enrollment in the trial (date of first signature of informed consent, Dec 2009) until End of Treatment visit. ] [ Designated as safety issue: No ]
  • Time to Symptom Progression (TTSP) [ Time Frame: Time from randomization to symptomatic progression reported between the day of first patient randomised, Dec 2009, until the cut-off date expected May 2020 ] [ Designated as safety issue: No ]
    Time from randomization to symptomatic progression. Symptomatic progression is defined as an increase (worsening) of the ASBI (The Average Symptomatic Burden Index i.e., the mean of the six major lung cancer specific symptom scores of the LCSS subject scale). Worsening is defined as a 10% increase in the scale breadth from the baseline score.

  • Time to Progression (TTP) [ Time Frame: Time from randomization to radiological confirmation of progressive disease (PD) reported between the day of first patient randomised, Dec 2009, until the cut-off date expected May 2020 ] [ Designated as safety issue: No ]
    Time from randomization to the radiological confirmation of progression performed according to Response Evaluation Criteria In Solid Tumors (RECIST). If radiological confirmation cannot be obtained but a subject is withdrawn from trial treatment due to PD, TTP will be measured from the date of randomization to the date of discontinuation of trial treatment. TTP of subjects without PD at the time of analysis will be censored at the time of last contact.

  • Progression Free Survival (PFS) Time [ Time Frame: Time from randomization to objective tumor progression or death (whichever occurs earlier)] reported between the day of first patient randomised, Dec 2009, until the cut-off date expected May 2020 ] [ Designated as safety issue: No ]
    Time from randomization to PD as determined by the investigator or death. PFS time for subjects without an event will be censored as of the date of last contact.

  • Time to Treatment Failure [ Time Frame: Time from randomization to the date of discontinuation of trial treatment], reported between the day of first patient randomised, Dec 2009, until the cut-off date expected May 2020 ] [ Designated as safety issue: No ]
    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 have missed two consecutive scheduled doses will be considered as treatment failures and the TTF will be calculated from the date of randomization to the date of their first missed treatment.


Estimated Enrollment: 500
Study Start Date: December 2009
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Arm
Pretreatment (Single Dose): 300 mg/m2 of IV cyclophosphamide plus Tecemotide (L-BLP25) plus Best Supportive Care (BSC)
Biological: Tecemotide (L-BLP25)
All subjects randomized to the investigational arm will begin the following treatment regimen within three days of randomization: A single I.V. infusion of 300 mg/m2 of cyclophosphamide administered exactly three days prior to the first Tecemotide (L-BLP25) vaccination. Subjects will then receive eight consecutive weekly subcutaneous vaccinations with 918 μg Tecemotide (L-BLP25) at weeks 1, 2, 3, 4, 5, 6, 7, and 8 (primary treatment phase) and then at six-week intervals, beginning at week 14 (maintenance phase) and continuing until disease progression is documented or the subject discontinues for any other reason.
Placebo Comparator: Control Arm
Pretreatment (Single Dose): 0.9% sodium chloride infusion Placebo plus BSC
Biological: Placebo
A single I.V. infusion of 0.9% sodium chloride will be administered to subjects randomized to the control arm exactly 3 days prior to treatment with placebo. Subjects will then receive eight consecutive weekly subcutaneous treatments with placebo at weeks 1, 2, 3, 4, 5, 6, 7, and 8 followed by maintenance treatment at 6 week intervals, beginning at week 14 and continuing until disease progression is documented.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented unresectable stage III NSCLC.
  • Documented stable disease or objective response, according to RECIST 1.0 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 radiosensitizing doses of chemotherapy are not acceptable. Radiotherapy must have delivered a radiation dose of ≥ 50 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 10⁹/L (whichever is greater); WBC ≥ 2.5 x 10⁹/L and hemoglobin ≥ 90 g/L
  • ≥18 years of age (or minimum age of legal consent consistent with local regulations, if minimum is > 18 years of age)

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 that in the opinion of the investigator could compromise the safety of the subject in this trial
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015443

Contacts
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

  Show 47 Study Locations
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Junliang Cai, MD Merck Serono (Beijing), Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA Darmstadt, Germany
  More Information

No publications provided by Merck KGaA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01015443     History of Changes
Other Study ID Numbers: EMR63325-012
Study First Received: October 1, 2009
Last Updated: June 23, 2014
Health Authority: China: Ministry of Health
China: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Health Sciences Authority
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs

Keywords provided by Merck KGaA:
Non-Small Cell Lung Carcinoma
stage III
unresectable
vaccine; Tecemotide ; L-BLP25
Cyclophosphamide
EMR 63325-012
placebo controlled
randomized
double blind
immunotherapy
Merck Serono
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer in the Asian Population

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on July 28, 2014