Clinical Trials /

Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC

NCT02669719

Description:

This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal growth factor receptor).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC
  • Official Title: A Randomized Phase II Study to Evaluate Efficacy and Safety of DCVAC/LuCa Added to Chemotherapy With Carboplatin and Pemetrexed vs Chemotherapy Alone in Patients With Stage IV Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: ILU02
  • NCT ID: NCT02669719

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
chemotherapy followed dendritic cellschemotherapy followed dendritic cells
pemetrexed and carboplatinchemotherapy

Purpose

This is a randomized, open-label, phaseⅡ study evaluating efficacy and safety of DC (dendritic cells) vaccine concurrent with chemotherapy compared to chemotherapy alone in patients with stage IV NSCLC (non small cell lung cancer) with wild-type EGFR (epidermal growth factor receptor).

Detailed Description

      Screening period: Patients will be screened for eligibility for the clinical study within a
      4-week period.

      Randomization and leukapheresis periods: When the patients meet all entry criteria, they will
      be randomized in a ratio of 1:1 into one of the following two groups:

      Group A (experimental group): Treatment with DC in addition to chemotherapy with 4-6 cycles
      of pemetrexed/carboplatin as first-line induction chemotherapy followed by pemetrexed as
      maintenance therapy. These patients will undergo leukapheresis within 1 week after
      randomization before start of treatment.

      Group B (control group): Chemotherapy with 4-6 cycles of pemetrexed/carboplatin as first-line
      induction chemotherapy followed by pemetrexed as maintenance therapy.

      Treatment periods:

      Standard of care chemotherapy will be administered to patients in both treatment groups in
      cycles. Each chemotherapy cycle will be 3 weeks long. Patients in the group A will start with
      chemotherapy 2-5 days after leukapheresis, and patients in the group B will start with
      chemotherapy within 2 weeks after randomization.

      Induction chemotherapy period

      Pemetrexed in combination with carboplatin will be administered on Day 1 of each 3-week
      chemotherapy cycle. After 2 cycles of chemotherapy, tumor response will be evaluated
      according to RECIST v. 1.1. Patients with progressive disease or intolerance to chemotherapy
      will terminate study treatment but will be followed for survival. Patients with complete
      response, partial response, or stable disease will continue chemotherapy with carboplatin and
      pemetrexed for a total of 6 cycles . After at least a total of 4 cycles of chemotherapy,
      patients can be administered pemetrexed maintenance chemotherapy.

      Maintenance chemotherapy period

      During the Maintenance chemotherapy period, patients will receive pemetrexed of each 3-week
      chemotherapy cycle. Chemotherapy with pemetrexed will be administered in up to a total of 21
      cycles or until disease progression or development of intolerance.

      DCVAC

      Patients in the group A will start with DC treatment on Day 15 of chemotherapy Cycle 3
      provided.During the Induction chemotherapy period, DC will be administered on Day 15 of each
      subsequent 3-week chemotherapy cycle of chemotherapy. During the Maintenance chemotherapy
      period, DC will be administered on Day 15 of every other 3-week chemotherapy cycle.

      Follow-up periods: Patients who complete or discontinue all study treatments after Cycle 3
      before disease progression will undergo disease evaluation by CT scan every 3 months until
      progression of the disease.Patients who discontinue all study treatments before or at Cycle 2
      for any reason or those who complete or discontinue all study treatments after Cycle 3 after
      disease progression will be followed up for survival. The survival data will be collected
      every 3 months by directly contacting the patient (or a relative/caretaker) by phone until
      death from any reason or termination of the study. The clinical study will be terminated when
      at least 45 PFS (progression-free survival) events have been reached, which is assumed to
      happen approximately 24 months after start of treatment of the first patient included in the
      study.
    

Trial Arms

NameTypeDescriptionInterventions
chemotherapy followed dendritic cellsExperimentalpemetrexed and carboplatin chemotherapy followed dendritic cells infusion from Cycle 3
    chemotherapyActive Comparatorpemetrexed and carboplatin chemotherapy only
    • pemetrexed and carboplatin

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Histologically or cytologically confirmed stage IV, non-squamous, wild-type
                 EGFR,ALK-negative NSCLC
    
              2. Signed ICF and ability to comply with this protocol
    
              3. 18 years of age or older
    
              4. ECOG performance status of 0-1
    
              5. Patients must have measurable disease as defined by RECIST v. 1.1
    
              6. Systematic treatment naive with respect to the currently diagnosed NSCLC
    
              7. Patients must have recovered from toxicity of previous therapy. Recovery is defined as
                 less than or equal to grade 2 toxicity according to National Cancer Institute Common
                 Terminology Criteria for Adverse Events (NCI CTCAE) (except alopecia).
    
              8. Sufficient hematologic and organ function for leukapheresis and chemotherapy:
    
                   -  WBC equal to or higher than 4×10^9 /L
    
                   -  Neutrophil equal to or higher than 1.5×10^9 /L
    
                   -  PLT equal to or higher than 100×10^9 /L
    
                   -  Hemoglobin equal to or higher than9 g/dL (90 g/L)
    
                   -  Total bilirubin less than or equal to 1.5 times upper limit of normal (benign
                      hereditary hyperbilirubinemias, eg, Gilbert's syndrome are permitted)
    
                   -  Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
                      alkaline phosphatase (ALP) should be less than or equal to 3 times upper limit of
                      normal. ALP, AST, and ALT less than or equal to 5 times upper limit of normal is
                      acceptable if liver has tumor involvement.
    
                   -  Creatinine clearance equal to or higher than 45 mL/min (calculated with the
                      standard Cockcroft and Gault formula)
    
              9. Women of childbearing potential and sexually active males must agree to use an
                 accepted and effective method of contraception (hormonal or barrier methods,
                 abstinence) prior to study entry and for the duration of the treatment plus 3 months
    
            Exclusion Criteria:
    
              1. Known active/untreated CNS metastases
    
              2. Any known primary immunodeficiency
    
              3. Any preexisting medical condition requiring long term chronic steroid or
                 immunosuppressive therapy
    
              4. HIV positivity, hepatitis B and/or C infection, syphilis
    
              5. Past or current history of malignant neoplasm other than lung carcinoma, except for
                 adequately 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 five years
    
              6. Patient's significant co-morbidities:
    
                   -  Cardiovascular diseases - unstable angina pectoris, uncontrolled hypertension,
                      myocardial infarction or ventricular arrhythmia or stroke within a 6-month period
                      before randomization, congestive heart failure or cardiac arrhythmia not
                      controlled by treatment
    
                   -  Active severe infections or other severe medical condition
    
              7. Participation in a clinical study using experimental therapy and
                 immunotherapy,monoclonal antibodies within the last 4 weeks prior to study entry
    
              8. Pregnant or breastfeeding woman
    
              9. History of severe hypersensitivity to pemetrexed and carboplatin and their
                 ingredients, and to DCVAC ingredients
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression-free survival
    Time Frame:the time from the date of randomization to the date of an event defined as the first progression or death due to any cause, whichever occurs first, up to 24 months
    Safety Issue:
    Description:randomization to the date of an event defined as the first progression or death due to any cause (institution of a new systemic anticancer treatment will also be considered as a progression event),whichever occurs first up to 24 months

    Secondary Outcome Measures

    Measure:Safety parameters in terms of AE, laboratory abnormalities, and vital signs
    Time Frame:through study completion, an average of 24 months
    Safety Issue:
    Description:adverse events [AEs], serious adverse events [SAEs], adverse events of special interest [AESIs], laboratory abnormalities, and vital signs
    Measure:Overall Survival
    Time Frame:From study treatment to death due to any cause, up to 24 months
    Safety Issue:
    Description:
    Measure:Objective Response Rate
    Time Frame:Objective Response Rate measured by RECIST criteria in ITT population, up to 24 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Shanghai Chest Hospital

    Trial Keywords

    • Lung Cancer
    • Chemotherapy
    • Immunotherapy

    Last Updated

    January 28, 2016