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Cellular Immunotherapy Synergize Chemotherapy in Patients With Stage IV NSCLC

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ClinicalTrials.gov Identifier: NCT02669719
Recruitment Status : Unknown
Verified January 2016 by Baohui Han, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
Sotio a.s.
Information provided by (Responsible Party):
Baohui Han, Shanghai Chest Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: chemotherapy followed dendritic cells Drug: pemetrexed and carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: chemotherapy followed dendritic cells
pemetrexed and carboplatin chemotherapy followed dendritic cells infusion from Cycle 3
Biological: chemotherapy followed dendritic cells
Pemetrexed and carboplatin would be administered on day 1 of each 3-week cycle.Patients will start with dendritic cells treatment on Day 15 of pemetrexed and carboplatin chemotherapy from Cycle 3 provided that both leukapheresis and the production of dendritic cells are successful.

Active Comparator: chemotherapy
pemetrexed and carboplatin chemotherapy only
Drug: pemetrexed and carboplatin
Chemotherapy with 4-6 cycles of pemetrexed and carboplatin as first-line induction chemotherapy followed by pemetrexed as maintenance therapy.




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Safety parameters in terms of AE, laboratory abnormalities, and vital signs [ Time Frame: through study completion, an average of 24 months ]
    adverse events [AEs], serious adverse events [SAEs], adverse events of special interest [AESIs], laboratory abnormalities, and vital signs

  2. Overall Survival [ Time Frame: From study treatment to death due to any cause, up to 24 months ]
  3. Objective Response Rate [ Time Frame: Objective Response Rate measured by RECIST criteria in ITT population, up to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669719


Contacts
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Contact: Baohui Han, MD 86-21-62821990 ext 3301 xkyyhan@gmail.com
Contact: Hua Zhong, MD 86-21-62821990 ext 3902 eddiedong8@hotmail.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Baohui Han, MD    86-21-62821990 ext 61201    xkyyhan@gmail.com   
Principal Investigator: Baohui Han, MD         
Sponsors and Collaborators
Shanghai Chest Hospital
Sotio a.s.
Investigators
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Principal Investigator: Baohui Han, MD Shanghai Chest Hospital
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Responsible Party: Baohui Han, Vice-President, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02669719    
Other Study ID Numbers: ILU02
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Baohui Han, Shanghai Chest Hospital:
Lung Cancer
Chemotherapy
Immunotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors