Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516685
Recruitment Status : Terminated (Due to inability of patient enrollment, decision taken to terminate in the interests of patients and later Malaysia is incorporated into global Phase 3 trial.)
First Posted : August 15, 2007
Last Update Posted : September 30, 2011
Information provided by:
Bioven Sdn. Bhd.

August 14, 2007
August 15, 2007
September 30, 2011
July 2007
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Survival [ Time Frame: Two and a half years ]
Same as current
Complete list of historical versions of study NCT00516685 on Archive Site
Assessment of immunogenecity, safety as well as preliminary assessment of objective response, time of progression and quality of life [ Time Frame: Two and a half years ]
Safety, immunogenicity and preliminary efficacy assessment [ Time Frame: Two and a half years ]
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Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
A Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy
The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).
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Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small-cell Lung Cancer (NSCLC) Stage IIIb/IV
Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
  • Experimental: Vaccine Group
    Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
    Intervention: Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
  • No Intervention: Control Group
    Patients in this arm will only receive Best Supportive Care.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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Inclusion Criteria:

  • Patients who have signed the informed consent form.
  • Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery.
  • Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using CT scan.
  • Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks.
  • Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD.
  • ECOG status 0 to 2.
  • Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range.
  • Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST.

Exclusion Criteria:

  • Patients who are candidates for combined modality treatment.
  • Patients who are receiving immunosuppressive therapy including corticosteroids.
  • Patients who have received immunotherapy within the previous 3 months.
  • Patients who have participated in a clinical study within the previous 30 days.
  • Patients who may be allergic to any component of the vaccine.
  • Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol.
  • Patients bearing brain metastasis from the primary lung tumor.
  • Patients bearing a second primary tumor.
  • Patients showing progressive disease after finishing first line chemotherapy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CT 07-03
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Bioven Sdn. Bhd.
Not Provided
Bioven Sdn. Bhd.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP